Trial Outcomes & Findings for A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection (NCT NCT04342663)

Last Updated: 2021-07-09

Results Overview

Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (\<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation \>92%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

152 participants

Primary outcome timeframe

RCT (approximately 15 days)

Results posted on

2021-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	Fluvoxamine Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days. Fluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.	Placebo Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days. Placebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.
Overall Study STARTED	80	72
Overall Study COMPLETED	62	53
Overall Study NOT COMPLETED	18	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluvoxamine n=80 Participants Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days. Fluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.	Placebo n=72 Participants Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days. Placebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.	Total n=152 Participants Total of all reporting groups
Age, Continuous	46 years n=99 Participants	45 years n=107 Participants	46 years n=206 Participants
Sex: Female, Male Female	56 Participants n=99 Participants	53 Participants n=107 Participants	109 Participants n=206 Participants
Sex: Female, Male Male	24 Participants n=99 Participants	19 Participants n=107 Participants	43 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=99 Participants	66 Participants n=107 Participants	141 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	18 Participants n=99 Participants	20 Participants n=107 Participants	38 Participants n=206 Participants
Race (NIH/OMB) White	56 Participants n=99 Participants	50 Participants n=107 Participants	106 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants
Co-existing conditions Asthma	17 Participants n=99 Participants	9 Participants n=107 Participants	26 Participants n=206 Participants
Co-existing conditions Hypertension	15 Participants n=99 Participants	15 Participants n=107 Participants	30 Participants n=206 Participants
Co-existing conditions Diabetes	9 Participants n=99 Participants	8 Participants n=107 Participants	17 Participants n=206 Participants
Co-existing conditions High cholesterol	7 Participants n=99 Participants	7 Participants n=107 Participants	14 Participants n=206 Participants
Co-existing conditions Hyperthyroidism	6 Participants n=99 Participants	6 Participants n=107 Participants	12 Participants n=206 Participants
Co-existing conditions Anxiety	5 Participants n=99 Participants	1 Participants n=107 Participants	6 Participants n=206 Participants
Co-existing conditions Arthritis	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Co-existing conditions Depression	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Body mass index category Underweight (<18.5)	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Body mass index category Normal (18.5-24.9)	14 Participants n=99 Participants	7 Participants n=107 Participants	21 Participants n=206 Participants
Body mass index category Overweight (25-29.9)	22 Participants n=99 Participants	22 Participants n=107 Participants	44 Participants n=206 Participants
Body mass index category Obese (≥30)	43 Participants n=99 Participants	42 Participants n=107 Participants	85 Participants n=206 Participants
Oxygen saturation	97 percentage of oxygen saturation n=99 Participants	97 percentage of oxygen saturation n=107 Participants	97 percentage of oxygen saturation n=206 Participants
Most severe COVID 19 symptom at baseline Loss of sense of smell	26 Participants n=99 Participants	18 Participants n=107 Participants	44 Participants n=206 Participants
Most severe COVID 19 symptom at baseline Fatigue	17 Participants n=99 Participants	18 Participants n=107 Participants	35 Participants n=206 Participants
Most severe COVID 19 symptom at baseline Body aches	9 Participants n=99 Participants	13 Participants n=107 Participants	22 Participants n=206 Participants
Most severe COVID 19 symptom at baseline Cough	9 Participants n=99 Participants	1 Participants n=107 Participants	10 Participants n=206 Participants
Most severe COVID 19 symptom at baseline Subjective fever	8 Participants n=99 Participants	4 Participants n=107 Participants	12 Participants n=206 Participants
Most severe COVID 19 symptom at baseline Loss of appetite	3 Participants n=99 Participants	8 Participants n=107 Participants	11 Participants n=206 Participants
Most severe COVID 19 symptom at baseline Chills	3 Participants n=99 Participants	6 Participants n=107 Participants	9 Participants n=206 Participants
Most severe COVID 19 symptom at baseline Shortness of breath	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Most severe COVID 19 symptom at baseline Loss of taste	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Most severe COVID 19 symptom at baseline Nausea	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants

PRIMARY outcome

Timeframe: RCT (approximately 15 days)

Population: The primary and secondary end points were measured using participants' self-reported responses on twice-daily surveys during the 15 days after randomization that were corroborated by research staff with phone contact.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=80 Participants Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days. Fluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.	Placebo n=72 Participants Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days. Placebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.
Number of Participants Who Met Clinical Worsening	0 Participants	6 Participants

SECONDARY outcome

Timeframe: RCT (approximately 15 days)

(0) none; (1) moderate severity of illness as defined by O2 saturation \<92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation \<92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=80 Participants Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days. Fluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.	Placebo n=72 Participants Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days. Placebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.
Clinical Deterioration on a Likert-type Scale (0-6) 0 (none)	80 Participants	66 Participants
Clinical Deterioration on a Likert-type Scale (0-6) 1, shortness of breath and oxygen saturation less than 92% but no supplemental oxygen needed	0 Participants	2 Participants
Clinical Deterioration on a Likert-type Scale (0-6) 2, O2 saturation plus supplemental oxygen requirement	0 Participants	0 Participants
Clinical Deterioration on a Likert-type Scale (0-6) 3, oxygen saturation less than 92% + supplemental O2 and hospitalized related to dyspnea or hypoxia	0 Participants	3 Participants
Clinical Deterioration on a Likert-type Scale (0-6) 4, the above, plus ventilator support requirement;	0 Participants	0 Participants
Clinical Deterioration on a Likert-type Scale (0-6) 5, oxygen < 92%, + supplemental O2, hospitalized related to dyspnea/hypoxia + ventilator 3 days	0 Participants	1 Participants
Clinical Deterioration on a Likert-type Scale (0-6) 6, Death	0 Participants	0 Participants

Adverse Events

Fluvoxamine

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fluvoxamine n=80 participants at risk Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days. Fluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.	Placebo n=72 participants at risk Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days. Placebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.
General disorders Dehydration	1.2% 1/80 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	0.00% 0/72 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
General disorders Exacerbation of COVID 19 with hospitalization	0.00% 0/80 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	1.4% 1/72 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
General disorders Flank Pain (hospitalized)	0.00% 0/80 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	1.4% 1/72 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
Respiratory, thoracic and mediastinal disorders Acute chronic respiratory failure with hypoxia and hypercapnia (hospitalized)	0.00% 0/80 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	1.4% 1/72 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
Respiratory, thoracic and mediastinal disorders Bilateral multi-focal pneumonia with shortness of breath and low oxygen saturation (hospitalized)	0.00% 0/80 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	1.4% 1/72 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.

Other adverse events

Additional Information

Dr. Eric Lenze

Washington University School of Medicine

Phone: 314-362-5154

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Fluvoxamine n=80 participants at risk Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days. Fluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.	Placebo n=72 participants at risk Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days. Placebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.8% 3/80 • Number of events 3 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	8.3% 6/72 • Number of events 6 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
Respiratory, thoracic and mediastinal disorders Shortness of breath	2.5% 2/80 • Number of events 2 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	5.6% 4/72 • Number of events 4 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
Gastrointestinal disorders Headache or head pain	2.5% 2/80 • Number of events 2 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	1.4% 1/72 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
Gastrointestinal disorders Gastroenteritis, nausea, or vomiting	1.2% 1/80 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	6.9% 5/72 • Number of events 5 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
Musculoskeletal and connective tissue disorders Muscle aches	1.2% 1/80 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	0.00% 0/72 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
General disorders Bacterial infection	1.2% 1/80 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	0.00% 0/72 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
General disorders Vasovagal syncope	1.2% 1/80 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	0.00% 0/72 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
General disorders Teeth chattering	1.2% 1/80 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	0.00% 0/72 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
General disorders Dehydration	1.2% 1/80 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	0.00% 0/72 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
Respiratory, thoracic and mediastinal disorders Low oxygen saturation or hypoxia	0.00% 0/80 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	8.3% 6/72 • Number of events 6 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
Respiratory, thoracic and mediastinal disorders Chest pain or tightness	0.00% 0/80 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	2.8% 2/72 • Number of events 2 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
General disorders Fever	0.00% 0/80 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	1.4% 1/72 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/80 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	1.4% 1/72 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
Blood and lymphatic system disorders Hypercapnia	0.00% 0/80 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	1.4% 1/72 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.
General disorders Flank pain	0.00% 0/80 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.	1.4% 1/72 • Number of events 1 • Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.