Trial Outcomes & Findings for ACTIV-6: COVID-19 Study of Repurposed Medications - Arm E (Fluvoxamine 100) (NCT NCT05894564)
NCT ID: NCT05894564
Last Updated: 2024-11-15
Results Overview
Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1208 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2024-11-15
Participant Flow
Participant milestones
| Measure |
Arm E - Fluvoxamine 100
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
Arm E - Placebo
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Overall Study
STARTED
|
601
|
607
|
|
Overall Study
COMPLETED
|
592
|
589
|
|
Overall Study
NOT COMPLETED
|
9
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm E (Fluvoxamine 100)
Baseline characteristics by cohort
| Measure |
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Total
n=1181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
n=99 Participants
|
50 years
n=107 Participants
|
50 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
388 Participants
n=99 Participants
|
390 Participants
n=107 Participants
|
778 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=99 Participants
|
199 Participants
n=107 Participants
|
403 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
256 Participants
n=99 Participants
|
276 Participants
n=107 Participants
|
532 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
336 Participants
n=99 Participants
|
313 Participants
n=107 Participants
|
649 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black, African American, or African
|
51 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Middle Eastern or North African
|
35 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
422 Participants
n=99 Participants
|
409 Participants
n=107 Participants
|
831 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · None of the above
|
28 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Prefer not to answer
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · No response
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
592 Participants
n=99 Participants
|
589 Participants
n=107 Participants
|
1181 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Participants who recovered.
Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
Outcome measures
| Measure |
Arm E - Placebo
n=568 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=569 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Time to Sustained Recovery in Days
|
10 days
Interval 10.0 to 11.0
|
10 days
Interval 10.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Number of Participants With Hospitalization or Death
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Number of Participants With Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Data not collected as no participant deaths occurred.
Time to mortality was the number of days between drug receipt and death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
|
21 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: Participants with a COVID Clinical Progression Scale score available.
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Outcome measures
| Measure |
Arm E - Placebo
n=566 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=551 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.
0 = No clinical or virological evidence of infection
|
37 Participants
|
55 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.
1 = No limitation of activities
|
504 Participants
|
472 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.
2 = Limitation of activities
|
25 Participants
|
24 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.
3 = Hospitalized, no oxygen therapy
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.
4 = Hospitalized, on oxygen by mask or nasal prongs
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.
5 = Hospitalized, on non-invasive ventilation or high-flow oxygen
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.
6 = Hospitalized, on intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.
7 = Hospitalized, on ventilation + additional organ support pressors, RRT, ECMO)
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.
8 = Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: Participants with a COVID Clinical Progression Scale score available.
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Outcome measures
| Measure |
Arm E - Placebo
n=558 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=541 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
0 = No clinical or virological evidence of infection
|
36 Participants
|
39 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
1 = No limitation of activities
|
500 Participants
|
490 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
2 = Limitation of activities
|
22 Participants
|
12 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
3 = Hospitalized, no oxygen therapy
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
4 = Hospitalized, on oxygen by mask or nasal prongs
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
5 = Hospitalized, on non-invasive ventilation or high-flow oxygen
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
6 = Hospitalized, on intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
8 = Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Participants with a COVID Clinical Progression Scale score available.
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Outcome measures
| Measure |
Arm E - Placebo
n=544 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=537 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
0 = No clinical or virological evidence of infection
|
28 Participants
|
37 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
1 = No limitation of activities
|
502 Participants
|
488 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
2 = Limitation of activities
|
14 Participants
|
12 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
3 = Hospitalized, no oxygen therapy
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
4 = Hospitalized, on oxygen by mask or nasal prongs
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
5 = Hospitalized, on non-invasive ventilation or high-flow oxygen
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
6 = Hospitalized, on intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
8 = Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, and 120Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function.
Outcome measures
| Measure |
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 28
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 20.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 7
|
20 score on a scale
Interval 17.0 to 20.0
|
20 score on a scale
Interval 17.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 14
|
20 score on a scale
Interval 19.0 to 20.0
|
20 score on a scale
Interval 19.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 90
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 20.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 120
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 20.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, and 120Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue.
Outcome measures
| Measure |
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 7
|
8 score on a scale
Interval 4.0 to 10.0
|
8 score on a scale
Interval 4.0 to 11.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 14
|
5 score on a scale
Interval 4.0 to 8.0
|
6 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 28
|
4 score on a scale
Interval 4.0 to 8.0
|
4 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 90
|
4 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 7.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 120
|
4 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 7.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, and 120Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain.
Outcome measures
| Measure |
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 7
|
4 score on a scale
Interval 4.0 to 8.0
|
4 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 14
|
4 score on a scale
Interval 4.0 to 6.0
|
4 score on a scale
Interval 4.0 to 6.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 28
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 90
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 120
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, and 120Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domain with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression.
Outcome measures
| Measure |
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 7
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 14
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 28
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 90
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 120
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, and 120Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.
Outcome measures
| Measure |
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 7
|
4 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 6.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 14
|
4 score on a scale
Interval 4.0 to 5.5
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 28
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 90
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 120
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, and 120Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.
Outcome measures
| Measure |
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 7
|
20 score on a scale
Interval 16.0 to 20.0
|
19 score on a scale
Interval 15.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 14
|
20 score on a scale
Interval 17.0 to 20.0
|
20 score on a scale
Interval 16.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 28
|
20 score on a scale
Interval 19.0 to 20.0
|
20 score on a scale
Interval 18.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 90
|
20 score on a scale
Interval 19.0 to 20.0
|
20 score on a scale
Interval 19.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 120
|
20 score on a scale
Interval 19.0 to 20.0
|
20 score on a scale
Interval 19.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 90, and 120Population: Participants with data collected at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.
Outcome measures
| Measure |
Arm E - Placebo
n=589 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=592 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 7
|
9 score on a scale
Interval 7.0 to 12.0
|
9 score on a scale
Interval 7.0 to 12.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 14
|
8 score on a scale
Interval 6.0 to 11.0
|
8 score on a scale
Interval 7.0 to 11.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 28
|
8 score on a scale
Interval 6.0 to 10.0
|
8 score on a scale
Interval 6.0 to 10.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 90
|
8 score on a scale
Interval 6.0 to 10.0
|
8 score on a scale
Interval 6.0 to 10.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 120
|
8 score on a scale
Interval 6.0 to 10.0
|
8 score on a scale
Interval 6.0 to 10.0
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: Participants with data collected.
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.
Outcome measures
| Measure |
Arm E - Placebo
n=565 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=562 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Time Unwell in Days as Measured by the Symptom and Clinical Event Scale
|
11.45 days
Interval 11.25 to 11.66
|
11.28 days
Interval 11.06 to 11.48
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: Participants with data collected.
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.
Outcome measures
| Measure |
Arm E - Placebo
n=565 Participants
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Arm E - Fluvoxamine 100
n=562 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
|---|---|---|
|
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
|
3.32 days
Interval 3.07 to 3.58
|
3.52 days
Interval 3.27 to 3.78
|
Adverse Events
Arm E - Fluvoxamine 100
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm E - Placebo
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm E - Fluvoxamine 100
n=592 participants at risk
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.
Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
|
Arm E - Placebo
n=589 participants at risk
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Gastrointestinal disorders
Partial bowel obstruction
|
0.00%
0/592 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.17%
1/589 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Immune system disorders
Guillian Barre Syndrome
|
0.17%
1/592 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/589 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Gastrointestinal disorders
Ruptured appendix
|
0.00%
0/592 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.17%
1/589 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Metabolism and nutrition disorders
Diabetic ulcer NOS
|
0.00%
0/592 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.17%
1/589 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Gastrointestinal disorders
Diverticulitis intestinal perforated
|
0.00%
0/592 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.17%
1/589 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Immune system disorders
Asthma aggravated
|
0.17%
1/592 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/589 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Infections and infestations
Community Acquired Pneumonia
|
0.17%
1/592 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.00%
0/589 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/592 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
0.17%
1/589 • Participants who received study drug were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at follow up visits on day 90, 120, 180.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place