Trial Outcomes & Findings for Acute Respiratory Illness Surveillance (AcRIS) With Mobile Application in a Low-Interventional Decentralized Study. (NCT NCT04748445)

NCT ID: NCT04748445

Last Updated: 2024-02-23

Results Overview

Symptoms (fever, cough, difficult breathing, fatigue, runny nose, stuffy/blocked nose, sore throat, loss of taste/smell, chills, muscle pain, diarrhea, vomiting, headache, nausea, rigors, wheezing) recorded at least once daily in e-diary for 8 weeks \& rated 0:none to 4:severe for fever \& 0:none to 7:severe for other symptoms. Total symptom score=sum of all symptom scores in a recording session \& mean of daily total symptom score=average across available sessions for each day, range=0 to 109, higher value=more severe total symptoms. Baseline=average of values up to 7 days before 1st occurrence of new/increased symptoms. If no data in 7 days, average of endpoint values for closest 3 days prior to 7 days used as baseline. Linear mixed effect model used for analysis for change from baseline in each symptom versus day during well to sick period, with slope (without intercept) included as fixed effects and random effects. Fixed effect of slope, as population level estimate, was reported.

Recruitment status

COMPLETED

Target enrollment

9151 participants

Primary outcome timeframe

Baseline up to Day 56

Results posted on

2024-02-23

Participant Flow

This was an observational study involving collection of voice and respiratory symptoms data in participants in both the well state and sick state.

Participant milestones

Participant milestones
Measure
All Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Overall Study
STARTED
9151
Overall Study
COMPLETED
8520
Overall Study
NOT COMPLETED
631

Reasons for withdrawal

Reasons for withdrawal
Measure
All Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Overall Study
No longer met eligibility criteria
12
Overall Study
Other
36
Overall Study
Withdrawal by Subject
553
Overall Study
Lost to Follow-up
30

Baseline Characteristics

Acute Respiratory Illness Surveillance (AcRIS) With Mobile Application in a Low-Interventional Decentralized Study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=9151 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Age, Continuous
41.03 Years
STANDARD_DEVIATION 10.63 • n=99 Participants
Sex: Female, Male
Female
7235 Participants
n=99 Participants
Sex: Female, Male
Male
1916 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
793 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7915 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
443 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
116 Participants
n=99 Participants
Race (NIH/OMB)
Asian
89 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
18 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
1127 Participants
n=99 Participants
Race (NIH/OMB)
White
7112 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
452 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
237 Participants
n=99 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 56

Population: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study were included. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.

Symptoms (fever, cough, difficult breathing, fatigue, runny nose, stuffy/blocked nose, sore throat, loss of taste/smell, chills, muscle pain, diarrhea, vomiting, headache, nausea, rigors, wheezing) recorded at least once daily in e-diary for 8 weeks \& rated 0:none to 4:severe for fever \& 0:none to 7:severe for other symptoms. Total symptom score=sum of all symptom scores in a recording session \& mean of daily total symptom score=average across available sessions for each day, range=0 to 109, higher value=more severe total symptoms. Baseline=average of values up to 7 days before 1st occurrence of new/increased symptoms. If no data in 7 days, average of endpoint values for closest 3 days prior to 7 days used as baseline. Linear mixed effect model used for analysis for change from baseline in each symptom versus day during well to sick period, with slope (without intercept) included as fixed effects and random effects. Fixed effect of slope, as population level estimate, was reported.

Outcome measures

Outcome measures
Measure
All Participants
n=126 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Diarrhea
0.036 Scores on a scale
Standard Error 0.0077
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Chills
0.065 Scores on a scale
Standard Error 0.0110
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Cough
0.281 Scores on a scale
Standard Error 0.0361
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Difficulty breathing
0.113 Scores on a scale
Standard Error 0.0263
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Vomiting
0.005 Scores on a scale
Standard Error 0.0017
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Fatigue
0.259 Scores on a scale
Standard Error 0.0319
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Fever
0.029 Scores on a scale
Standard Error 0.0050
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Headache
0.194 Scores on a scale
Standard Error 0.0281
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Loss of taste or smell
0.103 Scores on a scale
Standard Error 0.0266
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Muscle pain
0.181 Scores on a scale
Standard Error 0.0268
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Nausea
0.044 Scores on a scale
Standard Error 0.0096
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Rigors
0.030 Scores on a scale
Standard Error 0.0085
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Runny nose
0.159 Scores on a scale
Standard Error 0.0216
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Wheezing
0.049 Scores on a scale
Standard Error 0.0174
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Mean of daily total symptom score
2.644 Scores on a scale
Standard Error 0.3279
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Sore throat
0.222 Scores on a scale
Standard Error 0.0330
Change From Baseline in Self-Reported Symptom Scores From Well-to-Sick State Through Day 56
Stuffy/blocked nose
0.337 Scores on a scale
Standard Error 0.0443

PRIMARY outcome

Timeframe: Baseline up to Day 56

Population: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.

Participants recorded voice features such as pitch, jitter once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Max Phonation Time: duration that sound is held for. Jitter Local Absolute: average absolute difference between consecutive periods. Indicates how unsteady the pitch is across neighboring glottal pulses. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.

Outcome measures

Outcome measures
Measure
All Participants
n=126 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Change From Baseline in Voice Features (AHH_Max Phonation Time, EE_Jitter Local Absolute, MM_Jitter Local Absolute) Values From Well-to-Sick State Through Day 56
AHH_Max Phonation Time: LSM (10^-1), SE (10^-2)
-1.519 Seconds
Standard Error 2.769
Change From Baseline in Voice Features (AHH_Max Phonation Time, EE_Jitter Local Absolute, MM_Jitter Local Absolute) Values From Well-to-Sick State Through Day 56
EE_Jitter Local Absolute: LSM (10^-8)
6.899 Seconds
Standard Error 0
Change From Baseline in Voice Features (AHH_Max Phonation Time, EE_Jitter Local Absolute, MM_Jitter Local Absolute) Values From Well-to-Sick State Through Day 56
MM_Jitter Local Absolute: LSM (10^-7)
-1.743 Seconds
Standard Error 0

PRIMARY outcome

Timeframe: Baseline up to Day 56

Population: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Harmonicity, flatness, shimmer recorded and assessed by phonemes: 'eee' and 'mmm' for 4 seconds, "ahh" sustained and 5-sentence reading passage. Cepstral Peak Prominence: voice quality measure. Harmonicity: degree of periodicity in signal. mel frequency cepstral coefficients (MFCC) mean: quantifies shape of spectrum. MFCC std: quantifies variation in spectral shape over time. Signal-to-noise ratio (SNR): how loud signal is compared to background. Shimmer Local dB: average absolute difference between amplitudes of consecutive periods (how unsteady sound intensity is across neighboring glottal pulses). Spectral Flatness: quantifies how tone-like a signal is based on spectral distribution. Third Octave Band: energy in 200 Hz third octave band relative to total. VLHR: degree of nasality. Linear mixed effect model used for analysis. Fixed effect of slope, as population level estimate is reported. Individual exponential factors for data presented have been mentioned in respective row title.

Outcome measures

Outcome measures
Measure
All Participants
n=126 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_Cepstral Peak Prominence LSM (10^-3), SE (10^-2)
-1.326 Decibel
Standard Error 1.174
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_Harmonicity LSM (10^-3), SE (10^-2)
7.667 Decibel
Standard Error 1.741
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 01 LSM (10^0), SE (10^-1)
1.268 Decibel
Standard Error 2.820
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 02 LSM (10^-1), SE (10^-1)
-1.752 Decibel
Standard Error 2.127
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 03 LSM (10^-1), SE (10^-1)
1.390 Decibel
Standard Error 1.262
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 04 LSM (10^-1), SE (10^-1)
-1.407 Decibel
Standard Error 1.194
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 05 LSM (10^-3), SE (10^-2)
-4.466 Decibel
Standard Error 8.869
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 06 LSM (10^-1), SE (10^-2)
-1.572 Decibel
Standard Error 9.127
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 07 LSM (10^-1), SE (10^-2)
1.248 Decibel
Standard Error 7.598
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 08 LSM (10^-1), SE (10^-2)
-1.054 Decibel
Standard Error 7.218
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 09 LSM (10^-2), SE (10^-2)
5.944 Decibel
Standard Error 6.536
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 10 LSM (10^-2), SE (10^-2)
-3.115 Decibel
Standard Error 6.007
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 11 LSM (10^-2), SE (10^-2)
-1.908 Decibel
Standard Error 5.932
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 12 LSM (10^-4), SE (10^-2)
-6.574 Decibel
Standard Error 5.105
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC mean 13 LSM (10^-3), SE (10^-2)
5.026 Decibel
Standard Error 5.176
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 01 LSM (10^-2), SE (10^-2)
8.365 Decibel
Standard Error 2.873
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 02 LSM (10^-2), SE (10^-2)
2.906 Decibel
Standard Error 1.181
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 03 LSM (10^-2), SE (10^-2)
3.960 Decibel
Standard Error 1.447
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 04 LSM (10^-2), SE (10^-2)
2.816 Decibel
Standard Error 1.026
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 05 LSM (10^-3), SE (10^-2)
7.814 Decibel
Standard Error 1.034
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 06 LSM (10^-2), SE (10^-3)
1.151 Decibel
Standard Error 8.443
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 07 LSM (10^-2), SE (10^-3)
2.528 Decibel
Standard Error 8.228
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 08 LSM (10^-2), SE (10^-3)
1.755 Decibel
Standard Error 7.204
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 09 LSM (10^-2), SE (10^-3)
2.673 Decibel
Standard Error 5.892
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 10 LSM (10^-2), SE (10^-3)
1.394 Decibel
Standard Error 5.642
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 11 LSM (10^-2), SE (10^-3)
1.547 Decibel
Standard Error 6.666
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 12 LSM (10^-2), SE (10^-3)
1.118 Decibel
Standard Error 6.122
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_MFCC std 13 LSM (10^-2), SE (10^-3)
1.160 Decibel
Standard Error 5.226
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_SNR LSM (10^-2), SE (10^-2)
4.771 Decibel
Standard Error 3.351
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_Shimmer Local dB LSM (10^-4), SE (10^-4)
8.053 Decibel
Standard Error 9.807
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_Spectral Flatness LSM (10^-2), SE (10^-2)
-3.945 Decibel
Standard Error 1.892
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_Third Octave Band LSM (10^-2), SE (10^-2)
-7.075 Decibel
Standard Error 8.409
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
EE_VLHR LSM (10^-2), SE (10^-2)
1.658 Decibel
Standard Error 3.607
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_Cepstral Peak Prominence LSM (10^-2), SE (10^-2)
1.172 Decibel
Standard Error 1.423
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_Harmonicity LSM (10^-3), SE (10^-2)
-1.285 Decibel
Standard Error 2.112
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 01 LSM (10^-1), SE (10^-1)
9.159 Decibel
Standard Error 2.641
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 02 LSM (10^-1), SE (10^-1)
-2.180 Decibel
Standard Error 1.894
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 03 LSM (10^-1), SE (10^-1)
1.821 Decibel
Standard Error 1.028
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 04 LSM (10^-1), SE (10^-2)
-2.064 Decibel
Standard Error 8.474
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 05 LSM (10^-1), SE (10^-2)
-1.265 Decibel
Standard Error 9.670
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 06 LSM (10^-2), SE (10^-2)
2.851 Decibel
Standard Error 9.960
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 07 LSM (10^-1), SE (10^-2)
1.209 Decibel
Standard Error 7.569
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 08 LSM (10^-1), SE (10^-2)
-2.215 Decibel
Standard Error 8.498
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 09 LSM (10^-2), SE (10^-2)
5.560 Decibel
Standard Error 7.072
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 10 LSM (10^-2), SE (10^-2)
1.214 Decibel
Standard Error 6.190
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 11 LSM (10^-1), SE (10^-2)
-1.106 Decibel
Standard Error 4.852
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 12 LSM (10^-2), SE (10^-2)
-4.884 Decibel
Standard Error 4.827
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC mean 13 LSM (10^-2), SE (10^-2)
3.600 Decibel
Standard Error 5.634
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 01 LSM (10^-2), SE (10^-2)
2.909 Decibel
Standard Error 3.096
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 02 LSM (10^-2), SE (10^-2)
1.720 Decibel
Standard Error 2.595
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 03 LSM (10^-3), SE (10^-2)
4.403 Decibel
Standard Error 1.503
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 04 LSM (10^-3), SE (10^-2)
7.542 Decibel
Standard Error 1.639
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 05 LSM (10^-2), SE (10^-3)
2.386 Decibel
Standard Error 8.233
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 06 LSM (10^-2), SE (10^-2)
1.593 Decibel
Standard Error 1.243
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 07 LSM (10^-3), SE (10^-2)
2.902 Decibel
Standard Error 1.082
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 08 LSM (10^-2), SE (10^-2)
1.615 Decibel
Standard Error 1.118
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 09 LSM (10^-2), SE (10^-2)
1.116 Decibel
Standard Error 1.104
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 10 LSM (10^-3), SE (10^-3)
-2.168 Decibel
Standard Error 9.632
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 11 LSM (10^-2), SE (10^-2)
1.394 Decibel
Standard Error 1.081
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 12 LSM (10^-2), SE (10^-3)
1.375 Decibel
Standard Error 6.622
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_MFCC std 13 LSM (10^-3), SE (10^-2)
-2.892 Decibel
Standard Error 1.205
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_SNR LSM (10^-3), SE (10^-2)
-3.105 Decibel
Standard Error 3.256
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_Shimmer Local dB LSM (10^-4), SE (10^-4)
6.145 Decibel
Standard Error 9.704
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_Spectral Flatness LSM (10^-2), SE (10^-2)
-2.911 Decibel
Standard Error 1.969
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_Third Octave Band LSM (10^-1), SE (10^-2)
-1.487 Decibel
Standard Error 8.770
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
MM_VLHR LSM (10^-3), SE (10^-2)
3.089 Decibel
Standard Error 3.396
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 01 LSM (10^-1), SE (10^-1)
8.362 Decibel
Standard Error 2.077
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 02 LSM (10^-2), SE (10^-1)
3.559 Decibel
Standard Error 1.147
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 03 LSM (10^-1), SE (10^-2)
2.043 Decibel
Standard Error 7.752
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 04 LSM (10^-2), SE (10^-2)
-8.280 Decibel
Standard Error 6.413
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 05 LSM (10^-2), SE (10^-2)
-2.415 Decibel
Standard Error 5.260
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 06 LSM (10^-1), SE (10^-2)
-1.209 Decibel
Standard Error 4.904
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 07 LSM (10^-2), SE (10^-2)
2.617 Decibel
Standard Error 4.639
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 08 LSM (10^-2), SE (10^-2)
-7.305 Decibel
Standard Error 4.267
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 09 LSM (10^-2), SE (10^-2)
-2.369 Decibel
Standard Error 4.428
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 10 LSM (10^-2), SE (10^-2)
-7.377 Decibel
Standard Error 3.339
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 11 LSM (10^-3), SE (10^-2)
8.703 Decibel
Standard Error 3.665
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 12 LSM (10^-2), SE (10^-2)
-7.414 Decibel
Standard Error 3.294
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC mean 13 LSM (10^-2), SE (10^-2)
2.929 Decibel
Standard Error 2.705
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 01 LSM (10^-1), SE (10^-2)
-2.717 Decibel
Standard Error 6.612
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 02 LSM (10^-2), SE (10^-2)
-5.798 Decibel
Standard Error 2.961
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 03 LSM (10^-2), SE (10^-2)
-1.008 Decibel
Standard Error 1.778
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 04 LSM (10^-2), SE (10^-2)
-2.230 Decibel
Standard Error 1.193
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 05 LSM (10^-2), SE (10^-2)
-1.336 Decibel
Standard Error 1.176
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 06 LSM (10^-3), SE (10^-2)
-6.497 Decibel
Standard Error 1.413
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 07 LSM (10^-2), SE (10^-3)
-1.213 Decibel
Standard Error 7.700
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 08 LSM (10^-3), SE (10^-3)
-7.959 Decibel
Standard Error 9.743
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 09 LSM (10^-3), SE (10^-3)
-4.137 Decibel
Standard Error 8.017
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 10 LSM (10^-4), SE (10^-3)
3.760 Decibel
Standard Error 7.531
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 11 LSM (10^-3), SE (10^-3)
-2.185 Decibel
Standard Error 5.703
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 12 LSM (10^-3), SE (10^-3)
7.716 Decibel
Standard Error 5.746
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_MFCC std 13 LSM (10^-3), SE (10^-3)
-4.019 Decibel
Standard Error 6.419
Change From Baseline in Voice Feature (Cepstral Peak Prominence, Harmonicity, MFCC Mean, MFCC Std, SNR, Shimmer Local dB, Spectral Flatness, Third Octave Band, and VLHR) Values From Well-to-Sick State Through Day 56
READ_SNR LSM (10^-3), SE (10^-2)
5.103 Decibel
Standard Error 2.737

PRIMARY outcome

Timeframe: Baseline up to Day 56

Population: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Voice features were recorded once daily in an electronic diary for 8 weeks. Assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Coefficient of Variation of F0: measures variation in pitch over time. MFCC 1st order delta: time-averaged estimate of first derivate of the MFCCs. MFCC 2nd order delta: time-averaged estimate of the second derivative of the MFCCs. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.

Outcome measures

Outcome measures
Measure
All Participants
n=126 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_Coefficient of Variation F0 LSM (10^-4), SE (10^-4)
2.975 Unitless
Standard Error 3.383
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 01 LSM (10^-3), SE (10^-3)
-5.601 Unitless
Standard Error 2.751
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 02 LSM (10^-3), SE (10^-3)
4.120 Unitless
Standard Error 1.464
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 03 LSM (10^-3), SE (10^-3)
-3.067 Unitless
Standard Error 1.053
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 04 LSM (10^-3), SE (10^-4)
2.780 Unitless
Standard Error 9.751
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 05 LSM (10^-3), SE (10^-4)
-1.324 Unitless
Standard Error 8.289
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 06 LSM (10^-4), SE (10^-4)
-2.606 Unitless
Standard Error 9.707
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 07 LSM (10^-4), SE (10^-4)
-5.071 Unitless
Standard Error 7.593
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 08 LSM (10^-4), SE (10^-4)
3.067 Unitless
Standard Error 6.273
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 09 LSM (10^-3), SE (10^-4)
-1.649 Unitless
Standard Error 7.998
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 10 LSM (10^-4), SE (10^-4)
8.236 Unitless
Standard Error 7.053
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 11 LSM (10^-4), SE (10^-4)
-2.920 Unitless
Standard Error 6.839
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 12 LSM (10^-4), SE (10^-4)
-3.363 Unitless
Standard Error 6.312
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 1st order delta 13 LSM (10^-4), SE (10^-4)
7.281 Unitless
Standard Error 5.677
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 01 LSM (10^-4), SE (10^-3)
5.153 Unitless
Standard Error 1.523
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 02 LSM (10^-3), SE (10^-4)
-1.330 Unitless
Standard Error 6.782
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 03 LSM (10^-4), SE (10^-4)
-1.560 Unitless
Standard Error 6.763
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 04 LSM (10^-5), SE (10^-4)
-9.713 Unitless
Standard Error 6.180
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 05 LSM (10^-4), SE (10^-4)
4.520 Unitless
Standard Error 5.576
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 06 LSM (10^-4), SE (10^-4)
-1.528 Unitless
Standard Error 5.586
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 07 LSM (10^-5), SE (10^-4)
-5.254 Unitless
Standard Error 4.217
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 08 LSM (10^-4), SE (10^-4)
-4.591 Unitless
Standard Error 3.830
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 09 LSM (10^-4), SE (10^-4)
7.046 Unitless
Standard Error 3.687
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 10 LSM (10^-4), SE (10^-4)
-1.564 Unitless
Standard Error 3.606
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 11 LSM (10^-5), SE (10^-4)
6.573 Unitless
Standard Error 2.810
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 12 LSM (10^-4), SE (10^-4)
-4.071 Unitless
Standard Error 3.664
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
EE_MFCC 2nd order delta 13 LSM (10^-4), SE (10^-4)
2.799 Unitless
Standard Error 3.317
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_Coefficient of Variation F0 LSM (10^-4), SE (10^-4)
1.123 Unitless
Standard Error 1.676
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 01 LSM (10^-5), SE (10^-3)
7.586 Unitless
Standard Error 2.882
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 02 LSM (10^-4), SE (10^-3)
8.249 Unitless
Standard Error 1.815
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 03 LSM (10^-3), SE (10^-3)
-1.188 Unitless
Standard Error 1.322
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 04 LSM (10^-4), SE (10^-3)
-7.258 Unitless
Standard Error 1.101
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 05 LSM (10^-3), SE (10^-4)
-1.326 Unitless
Standard Error 7.555
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 06 LSM (10^-4), SE (10^-3)
5.502 Unitless
Standard Error 1.056
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 07 LSM (10^-4), SE (10^-4)
-4.691 Unitless
Standard Error 7.305
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 08 LSM (10^-3), SE (10^-4)
-1.530 Unitless
Standard Error 7.820
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 09 LSM (10^-4), SE (10^-4)
4.166 Unitless
Standard Error 7.294
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 10 LSM (10^-3), SE (10^-4)
-2.112 Unitless
Standard Error 7.299
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 11 LSM (10^-4), SE (10^-4)
-7.706 Unitless
Standard Error 7.494
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 12 LSM (10^-4), SE (10^-4)
2.388 Unitless
Standard Error 6.494
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 1st order delta 13 LSM (10^-4), SE (10^-4)
2.121 Unitless
Standard Error 6.877
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 01 LSM (10^-3), SE (10^-3)
-2.784 Unitless
Standard Error 1.667
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 02 LSM (10^-4), SE (10^-4)
-1.368 Unitless
Standard Error 9.117
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 03 LSM (10^-3), SE (10^-4)
-1.551 Unitless
Standard Error 6.294
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 04 LSM (10^-3), SE (10^-4)
1.840 Unitless
Standard Error 7.343
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 05 LSM (10^-3), SE (10^-4)
1.290 Unitless
Standard Error 5.029
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 06 LSM (10^-4), SE (10^-4)
-1.473 Unitless
Standard Error 5.891
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 07 LSM (10^-4), SE (10^-4)
-5.556 Unitless
Standard Error 4.647
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 08 LSM (10^-3), SE (10^-4)
1.128 Unitless
Standard Error 5.339
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 09 LSM (10^-4), SE (10^-4)
-3.297 Unitless
Standard Error 5.134
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 10 LSM (10^-4), SE (10^-4)
-2.104 Unitless
Standard Error 3.528
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 11 LSM (10^-4), SE (10^-4)
5.126 Unitless
Standard Error 4.289
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 12 LSM (10^-4), SE (10^-4)
2.703 Unitless
Standard Error 4.094
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
MM_MFCC 2nd order delta 13 LSM (10^-4), SE (10^-4)
-2.020 Unitless
Standard Error 5.334
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 01 LSM (10^-3), SE (10^-4)
-2.660 Unitless
Standard Error 9.220
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 02 LSM (10^-4), SE (10^-4)
6.490 Unitless
Standard Error 4.448
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 03 LSM (10^-4), SE (10^-4)
1.355 Unitless
Standard Error 3.323
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 04 LSM (10^-5), SE (10^-4)
7.664 Unitless
Standard Error 2.574
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 05 LSM (10^-4), SE (10^-4)
-1.708 Unitless
Standard Error 2.028
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 06 LSM (10^-4), SE (10^-4)
2.510 Unitless
Standard Error 1.904
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 07 LSM (10^-4), SE (10^-4)
2.393 Unitless
Standard Error 1.627
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 08 LSM (10^-4), SE (10^-4)
4.111 Unitless
Standard Error 1.553
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 09 LSM (10^-5), SE (10^-4)
-4.151 Unitless
Standard Error 1.134
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 10 LSM (10^-4), SE (10^-4)
1.593 Unitless
Standard Error 1.291
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 11 LSM (10^-4), SE (10^-5)
1.893 Unitless
Standard Error 9.442
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 12 LSM (10^-4), SE (10^-5)
1.380 Unitless
Standard Error 6.614
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 1st order delta 13 LSM (10^-4), SE (10^-4)
1.166 Unitless
Standard Error 1.040
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 01 LSM (10^-3), SE (10^-4)
-1.190 Unitless
Standard Error 5.790
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 02 LSM (10^-4), SE (10^-4)
-4.504 Unitless
Standard Error 3.040
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 03 LSM (10^-4), SE (10^-4)
2.968 Unitless
Standard Error 3.334
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 04 LSM (10^-5), SE (10^-4)
-7.963 Unitless
Standard Error 2.101
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 05 LSM (10^-4), SE (10^-4)
5.075 Unitless
Standard Error 1.878
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 06 LSM (10^-4), SE (10^-4)
-1.880 Unitless
Standard Error 1.174
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 07 LSM (10^-4), SE (10^-4)
1.667 Unitless
Standard Error 1.164
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 08 LSM (10^-4), SE (10^-5)
1.531 Unitless
Standard Error 9.552
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 09 LSM (10^-4), SE (10^-4)
1.989 Unitless
Standard Error 1.076
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 10 LSM (10^-5), SE (10^-5)
5.573 Unitless
Standard Error 9.318
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 11 LSM (10^-5), SE (10^-5)
1.774 Unitless
Standard Error 8.677
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 12 LSM (10^-5), SE (10^-5)
7.327 Unitless
Standard Error 6.630
Change From Baseline in Voice Feature (Coefficient of Variation, Mel Frequency Cepstral Coefficients (MFCC) 1st Order Delta, MFCC 2nd Order Delta) Values From Well-to-Sick State Through Day 56
READ_MFCC 2nd order delta 13 LSM (10^-4), SE (10^-5)
1.534 Unitless
Standard Error 9.067

PRIMARY outcome

Timeframe: Baseline up to Day 56

Population: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Participants recorded voice features such as entropy once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Entropy: Shannon entropy of the spectral distribution. Quantifies tonailty similar to spectral flatness. "EE\_Entropy" and "MM\_Entropy" refer to this same measure computed on the "eee" and "mmm" phonemes, respectively. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.

Outcome measures

Outcome measures
Measure
All Participants
n=126 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Change From Baseline in Voice Features (EE_Entropy, MM_Entropy) Values From Well-to-Sick State Through Day 56
EE_Entropy: LSM (10^-3), SE (10^-3)
-1.931 Bit
Standard Error 3.554
Change From Baseline in Voice Features (EE_Entropy, MM_Entropy) Values From Well-to-Sick State Through Day 56
MM_Entropy: LSM (10^-4), SE (10^-3)
-1.479 Bit
Standard Error 2.847

PRIMARY outcome

Timeframe: Baseline up to Day 56

Population: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Participants recorded voice features once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Formant: frequency at which the vocal tract produces an acoustic resonance. Formant Bandwidth: the spectral width of the acoustic resonance. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.

Outcome measures

Outcome measures
Measure
All Participants
n=126 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
EE_Formant 1: LSM (10^-2), SE (10^-1)
-3.262 Hertz
Standard Error 4.487
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
EE_Formant 1 Bandwidth: LSM (10^-2), SE (10^-1)
-6.912 Hertz
Standard Error 5.997
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
EE_Formant 2: LSM (10^-1), SE (10^0)
1.985 Hertz
Standard Error 1.230
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
EE_Formant 2 Bandwidth: LSM (10^-1), SE (10^0)
6.573 Hertz
Standard Error 2.191
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
EE_Formant 3: LSM (10^-1), SE (10^-1)
6.504 Hertz
Standard Error 8.958
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
EE_Formant 3 Bandwidth: LSM (10^-2), SE (10^0)
9.459 Hertz
Standard Error 1.255
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
MM_Formant 1: LSM (10^-1), SE (10^-1)
6.945 Hertz
Standard Error 7.972
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
MM_Formant 1 Bandwidth: LSM (10^-2), SE (10^0)
2.424 Hertz
Standard Error 1.021
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
MM_Formant 2: LSM (10^-1), SE (10^0)
-9.256 Hertz
Standard Error 1.083
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
MM_Formant 2 Bandwidth: LSM (10^-1), SE (10^0)
9.350 Hertz
Standard Error 1.289
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
MM_Formant 3: LSM (10^0), SE (10^0)
2.105 Hertz
Standard Error 1.231
Change From Baseline in Voice Features (Formant and Formant Bandwidth) Values From Well-to-Sick State Through Day 56
MM_Formant 3 Bandwidth: LSM (10^0), SE (10^0)
1.664 Hertz
Standard Error 1.358

PRIMARY outcome

Timeframe: Baseline up to Day 56

Population: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Participants recorded voice features once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. The voiced frames rate indicates how much of the sound is voiced. EE and MM refer to the sounds on which the measure is computed. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.

Outcome measures

Outcome measures
Measure
All Participants
n=126 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Change From Baseline in Voice Features (EE_Voiced Frames, MM_Voiced Frames) Values From Well-to-Sick State Through Day 56
EE_Voiced Frames: LSM (10^-4), SE (10^-3)
-4.024 Frame per second
Standard Error 3.122
Change From Baseline in Voice Features (EE_Voiced Frames, MM_Voiced Frames) Values From Well-to-Sick State Through Day 56
MM_Voiced Frames: LSM (10^-4), SE (10^-4)
-6.624 Frame per second
Standard Error 7.961

PRIMARY outcome

Timeframe: Baseline up to Day 56

Population: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Voice features such as jitter were recorded once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Jitter Local: average absolute difference between consecutive periods divided by the average period as a percentage. Indicates how unsteady the pitch is across neighboring glottal pulses. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.

Outcome measures

Outcome measures
Measure
All Participants
n=126 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Change From Baseline in Voice Features (EE_Jitter Local, MM_Jitter Local) Values From Well-to-Sick State Through Day 56
EE_Jitter Local: LSM (10^-4), SE (10^-3)
8.654 Percentage of period
Standard Error 1.441
Change From Baseline in Voice Features (EE_Jitter Local, MM_Jitter Local) Values From Well-to-Sick State Through Day 56
MM_Jitter Local: LSM (10^-4), SE (10^-3)
-2.206 Percentage of period
Standard Error 3.176

PRIMARY outcome

Timeframe: Baseline up to Day 56

Population: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Voice features such as shimmer were once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Shimmer Local: average absolute difference between the amplitudes of consecutive periods divided by the average amplitude as a percentage. Indicates how unsteady the sound intensity is across neighboring glottal pulses. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor in addition to values mentioned. Individual exponential factors have been mentioned in respective row title.

Outcome measures

Outcome measures
Measure
All Participants
n=126 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Change From Baseline in Voice Features (EE_Shimmer Local, MM_Shimmer Local) Values From Well-to-Sick State Through Day 56
EE_Shimmer Local: LSM (10^-3), SE (10^-2)
7.567 Percentage of amplitude
Standard Error 1.120
Change From Baseline in Voice Features (EE_Shimmer Local, MM_Shimmer Local) Values From Well-to-Sick State Through Day 56
MM_Shimmer Local: LSM (10^-3), SE (10^-2)
6.060 Percentage of amplitude
Standard Error 1.101

PRIMARY outcome

Timeframe: Baseline up to Day 56

Population: Participants who initially were SARS-CoV-2, Influenza and/or RSV negative (at Swab 1) and had no acute symptoms, and became SARS-CoV-2, Influenza virus or RSV positive (at Swab 2) and symptomatic during the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Participants recorded voice features once daily in an electronic diary for 8 weeks. Voice assessments were done by 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Baseline was average of endpoint values up to 7 days before first occurrence of new/increased symptoms. If participant had no data in 7 days, average of endpoint values for closest 3 days prior to these 7 days was used as baseline. Linear mixed effect model was used for analysis for change from baseline in each voice feature versus day during the well to sick period, with slope (without intercept) included as fixed effects and random effects. The fixed effect of the slope, as the population level estimate, was reported. The data given has exponential factor (i.e. LSM\*10\^-2, SE\*10\^-3) in addition to values mentioned.

Outcome measures

Outcome measures
Measure
All Participants
n=126 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Change From Baseline in Voice Features (READ_Speaking Rate) Values From Well-to-Sick State Through Day 56
2.130 Syllable per second
Standard Error 3.211

SECONDARY outcome

Timeframe: Day 1 up to Day 56

Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, percentage of compliant days in total days of self-reported symptoms and total days of voice recordings as entered in the electronic diary were reported. Compliant days were calculated for the following and expressed as percentage: symptom compliance = number of compliant days of self-reported symptoms divided by the total number of days in the study. Voice compliance (expressed as percentage) = number of compliant days of completed voice recordings divided by the total number of days in the study. Partial voice compliance (expressed as percentage) = number of compliant days of partially completed voice recordings divided by the total number of days in the study. Symptom and voice compliance (expressed as percentage) = number of compliant days of self-reported symptoms and completed voice recordings divided by the total number of days in the study. Participants who experienced technical issues due to study operational errors were excluded.

Outcome measures

Outcome measures
Measure
All Participants
n=8755 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary
Symptom Compliance
33.81 Percentage of days
Standard Deviation 35.158
Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary
Voice Compliance
32.06 Percentage of days
Standard Deviation 34.535
Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary
Partial Voice Compliance
0.49 Percentage of days
Standard Deviation 1.369
Percentage of Compliant Days in Total Days of Symptoms and Total Days of Voice Recordings Entered in the Electronic Diary
Symptom and Voice Compliance
32.06 Percentage of days
Standard Deviation 34.535

SECONDARY outcome

Timeframe: Day 1 up to Day 56

Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study.

In this outcome measure, percentage was calculated over the number of days that the participant was able to complete the task for each recording. Participants were required to record their daily voice in electronic diary and the assessment included 2 phonemes: 'eee' and 'mmm' for 4 seconds (minimum 3 seconds), 1 phoneme: "ahh" sustained (as long as possible) and a 5-sentence reading passage. Quality recordings were defined as recordings exceeding signal-to-noise (SNR) and duration thresholds (i.e. SNR \>= 20 decibels \[dB\] that have duration \>= 3 seconds for phoneme and \>= 10 seconds for reading tasks). In the case of multiple electronic diary sessions per day, the session with the highest quality voice recordings for that day was used in this analysis.

Outcome measures

Outcome measures
Measure
All Participants
n=9151 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Percentage of Quality Voice Recordings
84.15 Percentage of quality recordings
Standard Deviation 20.23

SECONDARY outcome

Timeframe: Day 2 up to Day 43

Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.

In this outcome measure, percentage of participants with valid self-swab 1 and 2 results positive for SARS-COV-2, Flu A, Flu B, RSV and SARS-CoV-2 and/or Influenza (Flu A/Flu B) and/or RSV were reported.

Outcome measures

Outcome measures
Measure
All Participants
n=6259 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Self-swab 1: SARS-COV-2
6 Percentage of participants
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Self-swab 1: Flu A
0.2 Percentage of participants
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Self-swab 1: Flu B
0 Percentage of participants
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Self-swab 1: RSV
0.1 Percentage of participants
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Self-swab 1: SARS-CoV-2 and/or Influenza and/or RSV
6.3 Percentage of participants
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Self-swab 2: SARS-COV-2
7.7 Percentage of participants
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Self-swab 2: Flu A
0.2 Percentage of participants
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Self-swab 2: Flu B
0 Percentage of participants
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Self-swab 2: RSV
0.6 Percentage of participants
Percentage of Participants With a Positive Self-Swab Result for SARS-CoV-2 and/or Influenza and/or RSV
Self-swab 2: SARS-CoV-2 and/or Influenza and/or RSV
8.5 Percentage of participants

SECONDARY outcome

Timeframe: Day 2 up to Day 43

Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, percentage of participants who administered self-swab 1, self-swab 2 and self-swab 1 and 2 excluding participants who experienced technical issues due to study operational errors were reported.

Outcome measures

Outcome measures
Measure
All Participants
n=8755 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Percentage of Participants Who Administered Self-swab 1 and Self-swab 2
Participants who administered self-swab 1
43.4 Percentage of participants
Percentage of Participants Who Administered Self-swab 1 and Self-swab 2
Participants who administered self-swab 2
31.4 Percentage of participants
Percentage of Participants Who Administered Self-swab 1 and Self-swab 2
Participants who administered self-swab 1 and self-swab 2
28.3 Percentage of participants

SECONDARY outcome

Timeframe: Day 2 Up to Day 43

Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants had administered self swab 2 and were evaluable for this outcome measure.

In this outcome measure, number of days from symptom onset (reporting new or increased symptoms in the electronic diary) to the day of recording Swab 2 day in the electronic diary averaged across participants who administered self-swab 2 was reported.

Outcome measures

Outcome measures
Measure
All Participants
n=1578 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Number of Days Between Reporting Symptoms and Recording Swab 2 in the Electronic-Diary
18.98 Days
Standard Deviation 17.01

SECONDARY outcome

Timeframe: Day 2 Up to Day 43

Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.

In this outcome measure, 1) participants (par) who administered (adm) self-swab 2 (SS2) before Week 6 (W6) divided by the number of participants who reported new or increased (inc) symptoms (sym) in the electronic diary (e-diary) before W6 and 2) number of participants who reported new or increased symptoms in the e-diary before Week 6 divided by the number of participants who administered self-swab 2 before Week 6 were reported in percentage.

Outcome measures

Outcome measures
Measure
All Participants
n=2554 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Percentage of Participants Reporting Symptoms in the Electronic Diary Who Have a Self-swab Collected at or Around Symptom Onset
Par who adm SS2 before W6/par who reported new or inc symptoms in e-diary before W6
9.3 Percentage of participants
Percentage of Participants Reporting Symptoms in the Electronic Diary Who Have a Self-swab Collected at or Around Symptom Onset
Par who reported new or inc sym in e-diary before W6/par who adm SS2 before W6
22.3 Percentage of participants

SECONDARY outcome

Timeframe: Day 2 Up to Day 43

Population: Full analysis set included all participants who signed the informed consent document and enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.

In this outcome measure, percentage of participants with valid (positive or negative) self-swab results for SARS-CoV-2, Flu A, Flu b and RSV were reported.

Outcome measures

Outcome measures
Measure
All Participants
n=6788 Participants
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Percentage of Participants Who Administered Self-swabs With Valid Results
Positive or negative self-swab 1 result for SARS-CoV-2
91.24 Percentage of participants
Percentage of Participants Who Administered Self-swabs With Valid Results
Positive or negative self-swab 1 result for Flu A
91.21 Percentage of participants
Percentage of Participants Who Administered Self-swabs With Valid Results
Positive or negative self-swab 1 result for Flu B
91.21 Percentage of participants
Percentage of Participants Who Administered Self-swabs With Valid Results
Positive or negative self-swab 1 result for RSV
91.21 Percentage of participants
Percentage of Participants Who Administered Self-swabs With Valid Results
Positive or negative self-swab 2 result for SARS-CoV-2
93.57 Percentage of participants
Percentage of Participants Who Administered Self-swabs With Valid Results
Positive or negative self-swab 2 result for Flu A
93.57 Percentage of participants
Percentage of Participants Who Administered Self-swabs With Valid Results
Positive or negative self-swab 2 result for Flu B
93.57 Percentage of participants
Percentage of Participants Who Administered Self-swabs With Valid Results
Positive or negative self-swab 2 result for RSV
93.57 Percentage of participants

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
All Participants
n=9151 participants at risk
Eligible participants aged 18 years and older recorded acute respiratory illnesses symptoms and voice data daily for up to a maximum of 8 weeks in both the well state and sick state, utilizing the electronic diary on their mobile application. Additionally, participants who performed two nasal self-swabs and the participants who tested positive for any of the three viruses (severe acute respiratory syndrome cornonavirus-2 \[SARS-CoV-2\], influenza virus and respiratory syncytial virus) at swab1 or swab 2, continued the study until end of Week 8. The participants who tested negative for the three viruses at swab 1 and swab 2, exited the study at end of Week 6.
Eye disorders
Lacrimation increased
0.01%
1/9151 • Maximum up to Day 56
Gastrointestinal disorders
Abdominal pain upper
0.01%
1/9151 • Maximum up to Day 56
Gastrointestinal disorders
Diarrhoea
0.07%
6/9151 • Maximum up to Day 56
Gastrointestinal disorders
Nausea
0.04%
4/9151 • Maximum up to Day 56
Gastrointestinal disorders
Vomiting
0.02%
2/9151 • Maximum up to Day 56
General disorders
Asthenia
0.01%
1/9151 • Maximum up to Day 56
General disorders
Chest discomfort
0.01%
1/9151 • Maximum up to Day 56
General disorders
Chills
0.04%
4/9151 • Maximum up to Day 56
General disorders
Fatigue
0.04%
4/9151 • Maximum up to Day 56
General disorders
Malaise
0.01%
1/9151 • Maximum up to Day 56
General disorders
Pain
0.05%
5/9151 • Maximum up to Day 56
General disorders
Pyrexia
0.08%
7/9151 • Maximum up to Day 56
Musculoskeletal and connective tissue disorders
Myalgia
0.01%
1/9151 • Maximum up to Day 56
Musculoskeletal and connective tissue disorders
Spinal pain
0.01%
1/9151 • Maximum up to Day 56
Nervous system disorders
Headache
0.12%
11/9151 • Maximum up to Day 56
Nervous system disorders
Migraine
0.01%
1/9151 • Maximum up to Day 56
Reproductive system and breast disorders
Dysmenorrhoea
0.01%
1/9151 • Maximum up to Day 56
Respiratory, thoracic and mediastinal disorders
Cough
0.04%
4/9151 • Maximum up to Day 56
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.01%
1/9151 • Maximum up to Day 56
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.04%
4/9151 • Maximum up to Day 56
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.05%
5/9151 • Maximum up to Day 56
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.04%
4/9151 • Maximum up to Day 56
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.05%
5/9151 • Maximum up to Day 56
Respiratory, thoracic and mediastinal disorders
Sneezing
0.01%
1/9151 • Maximum up to Day 56
Skin and subcutaneous tissue disorders
Rash
0.01%
1/9151 • Maximum up to Day 56

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Results disclosure agreements

  • Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
  • Publication restrictions are in place

Restriction type: OTHER