Trial · NCT05890586

ACTIV-6: COVID-19 Study of Repurposed Medications - Arm B (Fluvoxamine)

NCT05890586, Phase 3, Completed, Susanna Naggie, MD; results first posted 2023-08-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ACTIV-6: COVID-19 Study of Repurposed Medications - Arm B (Fluvoxamine). Trials, record NCT05890586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05890586

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ACTIV-6: COVID-19 Study of Repurposed Medications - Arm B (Fluvoxamine)
NCT number: NCT05890586
Status: Completed
Phases: Phase 3
Enrollment: 1,331 participants, actual
Lead sponsor: Susanna Naggie, MD
Conditions: Covid19
Interventions: Fluvoxamine, Placebo
First posted: 2023-06-06
Last updated: 2023-09-26
Results first posted: 2023-08-02

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Sustained Recovery in Days	Up to 28 days	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.
Secondary	Number of Participants With Hospitalization or Death	Up to 28 days
Secondary	Number of Participants With Mortality	Up to 28 days
Secondary	Time to Mortality	Up to 28 days	Time to mortality was the number of days between drug receipt and death.
Secondary	Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death	Up to 28 days
Secondary	Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7	Day 7	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.
Secondary	Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14	Day 14	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.
Secondary	Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28	Day 28	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.
Secondary	Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function	Day 7, 14, 28, and 90	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.
Secondary	Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue	Day 7, 14, 28, and 90	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.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Sustained Recovery in Days	Up to 28 days		days	MEDIAN
SECONDARY	Number of Participants With Hospitalization or Death	Up to 28 days	Data not collected on one participant.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Mortality	Up to 28 days	Data not collected on one participant.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Mortality	Up to 28 days	Data not collected on one participant.	days	MEAN
SECONDARY	Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death	Up to 28 days	Data not collected on one participant.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7	Day 7	Data not collected on 7 participants.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14	Day 14	Data not collected on 17 participants.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28	Day 28	Data not collected on 29 participants.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function	Day 7, 14, 28, and 90	Participants who responded to the quality of life survey at each timepoint.	score on a scale	MEDIAN
SECONDARY	Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue	Day 7, 14, 28, and 90	Participants who responded to the quality of life survey at each timepoint.	score on a scale	MEDIAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group124

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time to Sustained Recovery in Days	Arm B - Fluvoxamine 50	12	Inter-Quartile Range 11 to 14	days
Time to Sustained Recovery in Days	Arm B - Placebo	13	Inter-Quartile Range 12 to 13	days
Number of Participants With Hospitalization or Death	Arm B - Fluvoxamine 50	1		Participants
Number of Participants With Hospitalization or Death	Arm B - Placebo	3		Participants
Number of Participants With Mortality	Arm B - Fluvoxamine 50	0		Participants
Number of Participants With Mortality	Arm B - Placebo	0		Participants
Time to Mortality	Arm B - Fluvoxamine 50	NA	95% Confidence Interval NA to NA	days
Time to Mortality	Arm B - Placebo	NA	95% Confidence Interval NA to NA	days
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death	Arm B - Fluvoxamine 50	27		Participants
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death	Arm B - Placebo	26		Participants

1 to 10 of 124Source ClinicalTrials.gov

See all 124 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm B - Fluvoxamine 50	686
Overall Study	STARTED	Arm B - Placebo	645
Overall Study	COMPLETED	Arm B - Fluvoxamine 50	676
Overall Study	COMPLETED	Arm B - Placebo	615
Overall Study	NOT COMPLETED	Arm B - Fluvoxamine 50	10
Overall Study	NOT COMPLETED	Arm B - Placebo	30

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	COVID-19 pneumonia	Infections and infestations	Arm B - Fluvoxamine 50	0	676
serious	COVID-19 pneumonia	Infections and infestations	Arm B - Placebo	1	615
serious	Coronary vasospasm	Vascular disorders	Arm B - Fluvoxamine 50	0	676
serious	Coronary vasospasm	Vascular disorders	Arm B - Placebo	1	615
serious	COPD exacerbation	Respiratory, thoracic and mediastinal disorders	Arm B - Fluvoxamine 50	2	676
serious	COPD exacerbation	Respiratory, thoracic and mediastinal disorders	Arm B - Placebo	0	615
serious	Diabetes mellitus	Metabolism and nutrition disorders	Arm B - Fluvoxamine 50	0	676
serious	Diabetes mellitus	Metabolism and nutrition disorders	Arm B - Placebo	1	615
serious	Ophthalmic migraine	Eye disorders	Arm B - Fluvoxamine 50	0	676
serious	Ophthalmic migraine	Eye disorders	Arm B - Placebo	1	615

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm B - Fluvoxamine 50	0	676
Total, all-cause mortality	Arm B - Placebo	0	615
Total, other adverse events	Arm B - Fluvoxamine 50	0	676
Total, other adverse events	Arm B - Placebo	0	615
Total, serious adverse events	Arm B - Fluvoxamine 50	3	676
Total, serious adverse events	Arm B - Placebo	6	615

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U24TR001608	Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)	BENJAMIN, DANIEL K.	DUKE UNIVERSITY	NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES	2016 to 2022

Source NIH RePORTER

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm B - Fluvoxamine 50 vs Arm B - Placebo: Number of Participants With Mortality	Trial comparisons
Arm B - Fluvoxamine 50 vs Arm B - Placebo: Number of Participants With Hospitalization or Death	Trial comparisons
Arm B - Fluvoxamine 50 vs Arm B - Placebo: Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death	Trial comparisons
Arm B - Fluvoxamine 50 vs Arm B - Placebo: deaths from any cause	Trial comparisons
Arm B - Fluvoxamine 50 vs Arm B - Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05890586

GET https://conductscience.org/api/trials/v1/NCT05890586/results?page=2

API reference For AI assistants