Trial Outcomes & Findings for ACTIV-6: COVID-19 Study of Repurposed Medications - Arm B (Fluvoxamine) (NCT NCT05890586)
NCT ID: NCT05890586
Last Updated: 2023-09-26
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
1331 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2023-09-26
Participant Flow
Participant milestones
| Measure |
Arm B - Fluvoxamine 50
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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
|
686
|
645
|
|
Overall Study
COMPLETED
|
676
|
615
|
|
Overall Study
NOT COMPLETED
|
10
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm B (Fluvoxamine)
Baseline characteristics by cohort
| Measure |
Arm B - Fluvoxamine 50
n=646 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=583 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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=1229 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
47 years
n=7 Participants
|
47 years
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
372 Participants
n=5 Participants
|
327 Participants
n=7 Participants
|
699 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
273 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
527 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Prefer Not to Answer the Question
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
113 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
533 Participants
n=5 Participants
|
490 Participants
n=7 Participants
|
1023 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black, African American, or African
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Middle Eastern or North African
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
508 Participants
n=5 Participants
|
462 Participants
n=7 Participants
|
970 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · None of the above
|
26 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Prefer not to answer
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · No response
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
646 Participants
n=5 Participants
|
583 Participants
n=7 Participants
|
1229 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysTime 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 B - Fluvoxamine 50
n=646 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=583 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Time to Sustained Recovery in Days
|
12 days
Interval 11.0 to 14.0
|
13 days
Interval 12.0 to 13.0
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Data not collected on one participant.
Outcome measures
| Measure |
Arm B - Fluvoxamine 50
n=646 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=582 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Number of Participants With Hospitalization or Death
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Data not collected on one participant.
Outcome measures
| Measure |
Arm B - Fluvoxamine 50
n=646 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=582 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Number of Participants With Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Data not collected on one participant.
Time to mortality was the number of days between drug receipt and death.
Outcome measures
| Measure |
Arm B - Fluvoxamine 50
n=646 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=582 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Time to Mortality
|
NA days
Per the protocol/SAP, this endpoint is only analyzed if the number of total events exceeds 30. Due to the low event rate, the statistical analysis was not completed.
|
NA days
Per the protocol/SAP, this endpoint is only analyzed if the number of total events exceeds 30. Due to the low event rate, the statistical analysis was not completed.
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Data not collected on one participant.
Outcome measures
| Measure |
Arm B - Fluvoxamine 50
n=646 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=582 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
|
27 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: Data not collected on 7 participants.
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 B - Fluvoxamine 50
n=642 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=580 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
0 = No clinical or virological evidence of infection
|
55 Participants
|
34 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
1 = No limitation of activities
|
542 Participants
|
511 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
2 = Limitation of activities
|
45 Participants
|
33 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
3 = Hospitalized, no oxygen therapy
|
0 Participants
|
1 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
|
1 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: Data not collected on 17 participants.
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 B - Fluvoxamine 50
n=636 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=576 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
0 = No clinical or virological evidence of infection
|
39 Participants
|
37 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
1 = No limitation of activities
|
574 Participants
|
518 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
2 = Limitation of activities
|
23 Participants
|
21 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: Data not collected on 29 participants.
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 B - Fluvoxamine 50
n=630 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=570 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
0 = No clinical or virological evidence of infection
|
40 Participants
|
30 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
1 = No limitation of activities
|
569 Participants
|
528 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
2 = Limitation of activities
|
21 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, and 90Population: Participants who responded to the quality of life survey 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. Day 90 data to be reported by September 4, 2023.
Outcome measures
| Measure |
Arm B - Fluvoxamine 50
n=686 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=645 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 7
|
20 score on a scale
Interval 16.0 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 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 90
|
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, and 90Population: Participants who responded to the quality of life survey 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. Day 90 data to be reported by September 4, 2023.
Outcome measures
| Measure |
Arm B - Fluvoxamine 50
n=686 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=645 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 7
|
8 score on a scale
Interval 7.0 to 12.0
|
8 score on a scale
Interval 7.0 to 12.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 14
|
7 score on a scale
Interval 4.0 to 9.0
|
7 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 28
|
4.5 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 8.0
|
4 score on a scale
Interval 4.0 to 7.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey 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. Day 90 data to be reported by September 4, 2023.
Outcome measures
| Measure |
Arm B - Fluvoxamine 50
n=686 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=645 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
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 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 28
|
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 90
|
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, and 90Population: Participants who responded to the quality of life survey 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 depression. Day 90 data to be reported by September 4, 2023.
Outcome measures
| Measure |
Arm B - Fluvoxamine 50
n=686 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=645 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 7
|
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 - Depression
Day 14
|
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 28
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
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 5.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey 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 B - Fluvoxamine 50
n=686 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=645 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 7
|
5 score on a scale
Interval 4.0 to 7.0
|
5 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
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 - 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 5.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey 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. Day 90 data to be reported by September 4, 2023.
Outcome measures
| Measure |
Arm B - Fluvoxamine 50
n=686 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=645 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 7
|
16.5 score on a scale
Interval 14.0 to 20.0
|
18 score on a scale
Interval 14.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 14
|
20 score on a scale
Interval 16.0 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 18.0 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
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey 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. Day 90 data to be reported by September 4, 2023.
Outcome measures
| Measure |
Arm B - Fluvoxamine 50
n=686 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=645 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 7
|
10 score on a scale
Interval 8.0 to 12.0
|
10 score on a scale
Interval 7.0 to 12.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 14
|
9 score on a scale
Interval 6.0 to 12.0
|
9 score on a scale
Interval 6.0 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 11.0
|
8 score on a scale
Interval 6.0 to 11.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 90
|
8 score on a scale
Interval 6.0 to 11.0
|
8 score on a scale
Interval 6.0 to 10.0
|
SECONDARY outcome
Timeframe: Up to 14 daysThe 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 B - Fluvoxamine 50
n=646 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=583 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Time Unwell in Days as Measured by the Symptom and Clinical Event Scale
|
11.21 days
Interval 11.03 to 11.42
|
11.28 days
Interval 11.1 to 11.48
|
SECONDARY outcome
Timeframe: Up to 14 daysThe 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 B - Fluvoxamine 50
n=646 Participants
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=583 Participants
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
|
3.45 days
Interval 3.23 to 3.7
|
3.37 days
Interval 3.14 to 3.6
|
Adverse Events
Arm B - Fluvoxamine 50
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B - Placebo
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm B - Fluvoxamine 50
n=676 participants at risk
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 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 B - Placebo
n=615 participants at risk
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
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.
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/676 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
0.16%
1/615 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
|
Vascular disorders
Coronary vasospasm
|
0.00%
0/676 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
0.16%
1/615 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.30%
2/676 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
0.00%
0/615 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/676 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
0.16%
1/615 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
|
Eye disorders
Ophthalmic migraine
|
0.00%
0/676 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
0.16%
1/615 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
|
Injury, poisoning and procedural complications
Broken ankle
|
0.00%
0/676 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
0.16%
1/615 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
|
Infections and infestations
Infected finger
|
0.15%
1/676 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
0.00%
0/615 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
|
General disorders
Chest pain
|
0.00%
0/676 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
0.16%
1/615 • Up to 90 days
Participants 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 the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place