Trial Outcomes & Findings for Azithromycin for COVID-19 Treatment in Outpatients Nationwide (NCT NCT04332107)
NCT ID: NCT04332107
Last Updated: 2023-03-02
Results Overview
Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
263 participants
Primary outcome timeframe
14 days
Results posted on
2023-03-02
Participant Flow
Between May 22, 2020 and March 16, 2021, 604 participants were screened and 263 participants were enrolled. All study recruitment and enrollment was done remotely.
Common reasons for ineligibility included a negative COVID-19 test result (n=70), a COVID-19 test result outside of the 7 day window (n=118), could not be reached for consent (n=73), and under the age of 18 (19). A total of 341 screened participants were excluded.
Participant milestones
| Measure |
Azithromycin
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Day 3
STARTED
|
171
|
92
|
|
Day 3
COMPLETED
|
145
|
72
|
|
Day 3
NOT COMPLETED
|
26
|
20
|
|
Day 14
STARTED
|
148
|
78
|
|
Day 14
COMPLETED
|
131
|
70
|
|
Day 14
NOT COMPLETED
|
17
|
8
|
|
Day 21
STARTED
|
135
|
74
|
|
Day 21
COMPLETED
|
125
|
72
|
|
Day 21
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
| Measure |
Azithromycin
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Day 3
Lost to Follow-up
|
23
|
14
|
|
Day 3
Missing outcome data
|
3
|
6
|
|
Day 14
Lost to Follow-up
|
13
|
4
|
|
Day 14
Missing outcome data
|
4
|
4
|
|
Day 21
Lost to Follow-up
|
10
|
2
|
Baseline Characteristics
3 participants did not provide their gender information
Baseline characteristics by cohort
| Measure |
Azithromycin
n=171 Participants
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
n=92 Participants
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
n=171 Participants
|
44 years
n=92 Participants
|
43 years
n=263 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=168 Participants • 3 participants did not provide their gender information
|
57 Participants
n=92 Participants • 3 participants did not provide their gender information
|
174 Participants
n=260 Participants • 3 participants did not provide their gender information
|
|
Sex: Female, Male
Male
|
51 Participants
n=168 Participants • 3 participants did not provide their gender information
|
35 Participants
n=92 Participants • 3 participants did not provide their gender information
|
86 Participants
n=260 Participants • 3 participants did not provide their gender information
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
94 Participants
n=171 Participants
|
56 Participants
n=92 Participants
|
150 Participants
n=263 Participants
|
|
Race/Ethnicity, Customized
Latinx/Hispanic
|
49 Participants
n=171 Participants
|
27 Participants
n=92 Participants
|
76 Participants
n=263 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
11 Participants
n=171 Participants
|
1 Participants
n=92 Participants
|
12 Participants
n=263 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Asian
|
6 Participants
n=171 Participants
|
3 Participants
n=92 Participants
|
9 Participants
n=263 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
4 Participants
n=171 Participants
|
3 Participants
n=92 Participants
|
7 Participants
n=263 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Middle Eastern/Arab
|
2 Participants
n=171 Participants
|
1 Participants
n=92 Participants
|
3 Participants
n=263 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
1 Participants
n=171 Participants
|
0 Participants
n=92 Participants
|
1 Participants
n=263 Participants
|
|
Race/Ethnicity, Customized
Not reported (missing)
|
4 Participants
n=171 Participants
|
0 Participants
n=92 Participants
|
4 Participants
n=263 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Native American
|
0 Participants
n=171 Participants
|
1 Participants
n=92 Participants
|
1 Participants
n=263 Participants
|
|
Geographic region
West
|
79 Participants
n=171 Participants
|
40 Participants
n=92 Participants
|
119 Participants
n=263 Participants
|
|
Geographic region
Southeast
|
38 Participants
n=171 Participants
|
14 Participants
n=92 Participants
|
52 Participants
n=263 Participants
|
|
Geographic region
Southwest
|
24 Participants
n=171 Participants
|
16 Participants
n=92 Participants
|
40 Participants
n=263 Participants
|
|
Geographic region
Midwest
|
21 Participants
n=171 Participants
|
16 Participants
n=92 Participants
|
37 Participants
n=263 Participants
|
|
Geographic region
Northeast
|
9 Participants
n=171 Participants
|
6 Participants
n=92 Participants
|
15 Participants
n=263 Participants
|
|
Alcohol consumption >3x/week
|
23 Participants
n=171 Participants
|
9 Participants
n=92 Participants
|
32 Participants
n=263 Participants
|
|
Current cigarette smoker
|
13 Participants
n=171 Participants
|
5 Participants
n=92 Participants
|
18 Participants
n=263 Participants
|
|
Current marijuana user
|
9 Participants
n=171 Participants
|
6 Participants
n=92 Participants
|
15 Participants
n=263 Participants
|
|
Current e-cigarette/vaping
|
8 Participants
n=171 Participants
|
2 Participants
n=92 Participants
|
10 Participants
n=263 Participants
|
|
Current cigar use
|
1 Participants
n=171 Participants
|
1 Participants
n=92 Participants
|
2 Participants
n=263 Participants
|
|
Comorbidities
Asthma
|
21 Participants
n=171 Participants
|
11 Participants
n=92 Participants
|
32 Participants
n=263 Participants
|
|
Comorbidities
Hypertension
|
20 Participants
n=171 Participants
|
12 Participants
n=92 Participants
|
32 Participants
n=263 Participants
|
|
Comorbidities
Diabetes
|
5 Participants
n=171 Participants
|
5 Participants
n=92 Participants
|
10 Participants
n=263 Participants
|
|
Comorbidities
Chronic obstructive pulmonary disease
|
4 Participants
n=171 Participants
|
0 Participants
n=92 Participants
|
4 Participants
n=263 Participants
|
|
Comorbidities
Chronic kidney disease
|
1 Participants
n=171 Participants
|
1 Participants
n=92 Participants
|
2 Participants
n=263 Participants
|
|
Comorbidities
Cancer
|
1 Participants
n=171 Participants
|
0 Participants
n=92 Participants
|
1 Participants
n=263 Participants
|
|
Comorbidities
Stroke
|
1 Participants
n=171 Participants
|
1 Participants
n=92 Participants
|
2 Participants
n=263 Participants
|
|
Recent macrolide use (<30 days)
|
22 Participants
n=171 Participants
|
11 Participants
n=92 Participants
|
33 Participants
n=263 Participants
|
|
Recent hydroxychloroquine use (<7 days)
|
1 Participants
n=171 Participants
|
0 Participants
n=92 Participants
|
1 Participants
n=263 Participants
|
|
Current medications
ACE/ARB inhibitor
|
15 Participants
n=171 Participants
|
14 Participants
n=92 Participants
|
29 Participants
n=263 Participants
|
|
Current medications
Metformin
|
4 Participants
n=171 Participants
|
3 Participants
n=92 Participants
|
7 Participants
n=263 Participants
|
|
Current medications
Omeprazole
|
1 Participants
n=171 Participants
|
1 Participants
n=92 Participants
|
2 Participants
n=263 Participants
|
|
Current medications
Tacrolimus
|
1 Participants
n=171 Participants
|
0 Participants
n=92 Participants
|
1 Participants
n=263 Participants
|
|
Current vitamin/supplement use
Vitamin D
|
64 Participants
n=171 Participants
|
37 Participants
n=92 Participants
|
101 Participants
n=263 Participants
|
|
Current vitamin/supplement use
Vitamin C
|
61 Participants
n=171 Participants
|
33 Participants
n=92 Participants
|
94 Participants
n=263 Participants
|
|
Current vitamin/supplement use
Multivitamin
|
52 Participants
n=171 Participants
|
27 Participants
n=92 Participants
|
79 Participants
n=263 Participants
|
|
Current vitamin/supplement use
Zinc
|
49 Participants
n=171 Participants
|
20 Participants
n=92 Participants
|
69 Participants
n=263 Participants
|
|
Current vitamin/supplement use
Omega-3 fatty acid
|
14 Participants
n=171 Participants
|
6 Participants
n=92 Participants
|
20 Participants
n=263 Participants
|
|
Self-reported symptoms
Multiple symptoms
|
152 Participants
n=171 Participants
|
82 Participants
n=92 Participants
|
234 Participants
n=263 Participants
|
|
Self-reported symptoms
Cough
|
111 Participants
n=171 Participants
|
61 Participants
n=92 Participants
|
172 Participants
n=263 Participants
|
|
Self-reported symptoms
Fatigue
|
107 Participants
n=171 Participants
|
55 Participants
n=92 Participants
|
162 Participants
n=263 Participants
|
|
Self-reported symptoms
Fever
|
87 Participants
n=171 Participants
|
40 Participants
n=92 Participants
|
127 Participants
n=263 Participants
|
|
Self-reported symptoms
Myalgia
|
82 Participants
n=171 Participants
|
40 Participants
n=92 Participants
|
122 Participants
n=263 Participants
|
|
Self-reported symptoms
Anosmia
|
80 Participants
n=171 Participants
|
39 Participants
n=92 Participants
|
119 Participants
n=263 Participants
|
|
Self-reported symptoms
Sore throat
|
71 Participants
n=171 Participants
|
37 Participants
n=92 Participants
|
108 Participants
n=263 Participants
|
|
Self-reported symptoms
Diarrhea
|
45 Participants
n=171 Participants
|
20 Participants
n=92 Participants
|
65 Participants
n=263 Participants
|
|
Self-reported symptoms
Shortness of breath
|
45 Participants
n=171 Participants
|
17 Participants
n=92 Participants
|
62 Participants
n=263 Participants
|
|
Self-reported symptoms
Dizziness
|
39 Participants
n=171 Participants
|
15 Participants
n=92 Participants
|
54 Participants
n=263 Participants
|
|
Self-reported symptoms
Abdominal pain
|
29 Participants
n=171 Participants
|
12 Participants
n=92 Participants
|
41 Participants
n=263 Participants
|
|
Self-reported symptoms
None
|
12 Participants
n=171 Participants
|
6 Participants
n=92 Participants
|
18 Participants
n=263 Participants
|
|
Self-reported symptoms
Conjunctivitis
|
8 Participants
n=171 Participants
|
2 Participants
n=92 Participants
|
10 Participants
n=263 Participants
|
|
Number of symptoms
|
5 Number of symptoms
n=171 Participants
|
4 Number of symptoms
n=92 Participants
|
4 Number of symptoms
n=263 Participants
|
|
Duration of symptoms prior to test
|
3 days
n=171 Participants
|
3 days
n=92 Participants
|
3 days
n=263 Participants
|
|
Days between positive test and enrollment
|
3 days
n=171 Participants
|
2 days
n=92 Participants
|
3 days
n=263 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Percentage of participants who were symptom free at day 14 by randomized treatment group, overall and in pre-specified subgroups. Note that a single participant in the Azithromycin group did not have baseline symptom information.
Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no)
Outcome measures
| Measure |
Azithromycin
n=131 Participants
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
n=70 Participants
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Number of Participants Who Were Symptom Free at Day 14
Overall
|
66 Participants
|
35 Participants
|
|
Number of Participants Who Were Symptom Free at Day 14
Age <= 60 years
|
61 Participants
|
31 Participants
|
|
Number of Participants Who Were Symptom Free at Day 14
Age > 60 years
|
5 Participants
|
4 Participants
|
|
Number of Participants Who Were Symptom Free at Day 14
Asymptomatic at baseline
|
9 Participants
|
3 Participants
|
|
Number of Participants Who Were Symptom Free at Day 14
Symptomatic at baseline
|
57 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and will never be analyzed
Viral load by self-collected nasal swab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 daysPopulation: Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and won't ever be analyzed
Viral load by self-collected saliva swab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: This outcome is based on the 125 participants in the azithromycin group and the 72 participants in the placebo group who completed the trial.
All-cause mortality
Outcome measures
| Measure |
Azithromycin
n=125 Participants
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
n=72 Participants
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Adverse events were recorded at day 3 of the trial via an online questionnaire. Other adverse events were recorded in an open text field and included stomach cramps, light headedness, fatigue, ansomia, cough, and painful respiration.
Percentage of participants experiencing adverse events, including gastrointestinal side effects and rash
Outcome measures
| Measure |
Azithromycin
n=145 Participants
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
n=72 Participants
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Adverse Events
Diarrhea
|
60 Participants
|
12 Participants
|
|
Adverse Events
Nausea
|
32 Participants
|
7 Participants
|
|
Adverse Events
Abdominal Pain
|
25 Participants
|
1 Participants
|
|
Adverse Events
Vomiting
|
5 Participants
|
2 Participants
|
|
Adverse Events
Rash
|
4 Participants
|
2 Participants
|
|
Adverse Events
Other
|
10 Participants
|
3 Participants
|
|
Adverse Events
None
|
9 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and won't ever be analyzed
Prevalence of positive SARS-CoV-2 test by self-collected nasal swab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 daysPopulation: Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and won't ever be analyzed
Prevalence of positive SARS-CoV-2 test by self-collected saliva swab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 daysPopulation: Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and won't ever be analyzed
Prevalence of positive SARS-CoV-2 test by self-collected rectal swab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 daysPopulation: Participants whose samples were received back by the study team. The trial was terminated for futility, funding was withdraw and samples not analyzed and won't ever be analyzed
Prevalence of genetic macrolide resistance determinants by self-collected rectal swab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cumulative over 21 days reported (assessed at 3, 7, 14, 21 days)Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms through Day 21
Outcome measures
| Measure |
Azithromycin
n=125 Participants
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
n=72 Participants
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Secondary Outcomes Through Day 21
Other
|
10 Participants
|
9 Participants
|
|
Secondary Outcomes Through Day 21
Absence of symptoms
|
71 Participants
|
43 Participants
|
|
Secondary Outcomes Through Day 21
Fever
|
1 Participants
|
1 Participants
|
|
Secondary Outcomes Through Day 21
Cough
|
14 Participants
|
13 Participants
|
|
Secondary Outcomes Through Day 21
Diarrhea
|
4 Participants
|
1 Participants
|
|
Secondary Outcomes Through Day 21
Abdominal pain
|
0 Participants
|
1 Participants
|
|
Secondary Outcomes Through Day 21
Anosmia
|
12 Participants
|
9 Participants
|
|
Secondary Outcomes Through Day 21
Conjunctivitis
|
2 Participants
|
0 Participants
|
|
Secondary Outcomes Through Day 21
Sore throat
|
4 Participants
|
4 Participants
|
|
Secondary Outcomes Through Day 21
Shortness of breath
|
16 Participants
|
4 Participants
|
|
Secondary Outcomes Through Day 21
Myalgia
|
5 Participants
|
3 Participants
|
|
Secondary Outcomes Through Day 21
Fatigue
|
32 Participants
|
17 Participants
|
|
Secondary Outcomes Through Day 21
Dizziness
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Number of patients who reported emergency room visit information through Day 21
Number of emergency room visits \<24 hours
Outcome measures
| Measure |
Azithromycin
n=125 Participants
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
n=72 Participants
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Number of Participants With Emergency Room Visits
|
18 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Includes the total number of participants from 69 households in the placebo group and 134 households in the azithromycin group
Number of household members with confirmed or symptomatic COVID-19 through Day 21
Outcome measures
| Measure |
Azithromycin
n=522 Participants
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
n=278 Participants
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Number of Household Members With COVID-19 (Confirmed or Symptomatic)
|
33 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Participants that completed the day 21 questionnaire were included in this secondary analysis.
Deaths within the study
Outcome measures
| Measure |
Azithromycin
n=125 Participants
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
n=72 Participants
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Number of Participants That Died
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 21 DaysPopulation: Number of patients who reported hospitalization information through Day 21
Number of hospitalizations defined as a hospital stay or ER stay longer than 24 hours through 21 days post enrollment
Outcome measures
| Measure |
Azithromycin
n=125 Participants
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
n=72 Participants
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Number of Participants Reporting Hospitalization
|
5 Participants
|
0 Participants
|
Adverse Events
Azithromycin
Serious events: 0 serious events
Other events: 132 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Azithromycin
n=145 participants at risk
1.2g of oral azithromycin
Azithromycin: Participants will be shipped a single 1.2 g dose of oral azithromycin
|
Placebo
n=72 participants at risk
Matching placebo
Placebos: Participants will be shipped a dose of matching placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
41.4%
60/145 • 21 days
Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for \>= 24 hours) and/or if they had visited an emergency department or urgent care center.
|
16.7%
12/72 • 21 days
Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for \>= 24 hours) and/or if they had visited an emergency department or urgent care center.
|
|
Gastrointestinal disorders
Nausea
|
22.1%
32/145 • 21 days
Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for \>= 24 hours) and/or if they had visited an emergency department or urgent care center.
|
9.7%
7/72 • 21 days
Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for \>= 24 hours) and/or if they had visited an emergency department or urgent care center.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.2%
25/145 • 21 days
Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for \>= 24 hours) and/or if they had visited an emergency department or urgent care center.
|
1.4%
1/72 • 21 days
Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for \>= 24 hours) and/or if they had visited an emergency department or urgent care center.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
5/145 • 21 days
Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for \>= 24 hours) and/or if they had visited an emergency department or urgent care center.
|
2.8%
2/72 • 21 days
Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for \>= 24 hours) and/or if they had visited an emergency department or urgent care center.
|
|
Gastrointestinal disorders
Other
|
6.9%
10/145 • 21 days
Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for \>= 24 hours) and/or if they had visited an emergency department or urgent care center.
|
4.2%
3/72 • 21 days
Participants completed a survey at day 3 where they were asked if they had experienced any of the following symptoms since they took their study medication to assess possible adverse events: vomiting, nausea, diarrhea, rash, or abdominal pain. Participants were asked at every time point if they had stayed in a hospital setting (defined as in the emergency department or admitted to the hospital for \>= 24 hours) and/or if they had visited an emergency department or urgent care center.
|
Additional Information
Dr. Thomas Lietman, Director of the UCSF FI Proctor Foundation
University of California, San Francisco FI Proctor Foundation
Phone: 415-476-1442
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place