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

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ClinicalTrials.gov Identifier: NCT04342663
Recruitment Status : Completed
First Posted : April 13, 2020
Results First Posted : July 9, 2021
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions COVID 19
Coronavirus
Interventions Drug: Fluvoxamine
Drug: Placebo
Enrollment 152
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluvoxamine Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 80 72
Completed 62 53
Not Completed 18 19
Arm/Group Title Fluvoxamine Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 80 72 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 80 participants 72 participants 152 participants
46
(35 to 58)
45
(36 to 54)
46
(36 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 72 participants 152 participants
Female
56
  70.0%
53
  73.6%
109
  71.7%
Male
24
  30.0%
19
  26.4%
43
  28.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 72 participants 152 participants
Hispanic or Latino
3
   3.8%
2
   2.8%
5
   3.3%
Not Hispanic or Latino
75
  93.8%
66
  91.7%
141
  92.8%
Unknown or Not Reported
2
   2.5%
4
   5.6%
6
   3.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 72 participants 152 participants
American Indian or Alaska Native
0
   0.0%
1
   1.4%
1
   0.7%
Asian
3
   3.8%
1
   1.4%
4
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
  22.5%
20
  27.8%
38
  25.0%
White
56
  70.0%
50
  69.4%
106
  69.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   3.8%
0
   0.0%
3
   2.0%
Co-existing conditions  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 72 participants 152 participants
Asthma
17
  21.3%
9
  12.5%
26
  17.1%
Hypertension
15
  18.8%
15
  20.8%
30
  19.7%
Diabetes
9
  11.3%
8
  11.1%
17
  11.2%
High cholesterol
7
   8.8%
7
   9.7%
14
   9.2%
Hyperthyroidism
6
   7.5%
6
   8.3%
12
   7.9%
Anxiety
5
   6.3%
1
   1.4%
6
   3.9%
Arthritis
4
   5.0%
3
   4.2%
7
   4.6%
Depression
1
   1.3%
4
   5.6%
5
   3.3%
Body mass index category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 72 participants 152 participants
Underweight (<18.5)
1
   1.3%
1
   1.4%
2
   1.3%
Normal (18.5-24.9)
14
  17.5%
7
   9.7%
21
  13.8%
Overweight (25-29.9)
22
  27.5%
22
  30.6%
44
  28.9%
Obese (≥30)
43
  53.8%
42
  58.3%
85
  55.9%
Oxygen saturation  
Median (Inter-Quartile Range)
Unit of measure:  Percentage of oxygen saturation
Number Analyzed 80 participants 72 participants 152 participants
97
(96 to 98)
97
(96 to 98)
97
(96 to 98)
Most severe COVID 19 symptom at baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 72 participants 152 participants
Loss of sense of smell
26
  32.5%
18
  25.0%
44
  28.9%
Fatigue
17
  21.3%
18
  25.0%
35
  23.0%
Body aches
9
  11.3%
13
  18.1%
22
  14.5%
Cough
9
  11.3%
1
   1.4%
10
   6.6%
Subjective fever
8
  10.0%
4
   5.6%
12
   7.9%
Loss of appetite
3
   3.8%
8
  11.1%
11
   7.2%
Chills
3
   3.8%
6
   8.3%
9
   5.9%
Shortness of breath
2
   2.5%
1
   1.4%
3
   2.0%
Loss of taste
2
   2.5%
2
   2.8%
4
   2.6%
Nausea
1
   1.3%
1
   1.4%
2
   1.3%
1.Primary Outcome
Title Number of Participants Who Met Clinical Worsening
Hide Description 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%.
Time Frame RCT (approximately 15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluvoxamine Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 80 72
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6
   8.3%
2.Secondary Outcome
Title Clinical Deterioration on a Likert-type Scale (0-6)
Hide Description (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.
Time Frame RCT (approximately 15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluvoxamine Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 80 72
Measure Type: Count of Participants
Unit of Measure: Participants
0 (none)
80
 100.0%
66
  91.7%
1, shortness of breath and oxygen saturation less than 92% but no supplemental oxygen needed
0
   0.0%
2
   2.8%
2, O2 saturation plus supplemental oxygen requirement
0
   0.0%
0
   0.0%
3, oxygen saturation less than 92% + supplemental O2 and hospitalized related to dyspnea or hypoxia
0
   0.0%
3
   4.2%
4, the above, plus ventilator support requirement;
0
   0.0%
0
   0.0%
5, oxygen < 92%, + supplemental O2, hospitalized related to dyspnea/hypoxia + ventilator 3 days
0
   0.0%
1
   1.4%
6, Death
0
   0.0%
0
   0.0%
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluvoxamine Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Fluvoxamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)      0/72 (0.00%)    
Hide Serious Adverse Events
Fluvoxamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/80 (1.25%)      6/72 (8.33%)    
General disorders     
Dehydration *  1/80 (1.25%)  1 0/72 (0.00%)  0
Exacerbation of COVID 19 with hospitalization * [1]  0/80 (0.00%)  0 1/72 (1.39%)  1
Flank Pain (hospitalized) *  0/80 (0.00%)  0 1/72 (1.39%)  1
Exacerbation of COVID 19 with hospitalization * [2]  0/80 (0.00%)  0 1/72 (1.39%)  1
Exacerbation of COVID 19 with hospitalization * [3]  0/80 (0.00%)  0 1/72 (1.39%)  1
Respiratory, thoracic and mediastinal disorders     
Acute chronic respiratory failure with hypoxia and hypercapnia (hospitalized) *  0/80 (0.00%)  0 1/72 (1.39%)  1
Bilateral multi-focal pneumonia with shortness of breath and low oxygen saturation (hospitalized) *  0/80 (0.00%)  0 1/72 (1.39%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Hospitalized for nausea, vomiting, and chest pain (O2 not below 92%)
[2]
Hospitalized for nausea, vomiting, fever, low oxygen saturation, and pneumonia
[3]
Hospitalized with nausea, fever, and pneumonia with requirement of supplemental oxygen to maintain oxygen saturation about 92%
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluvoxamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/80 (16.25%)      28/72 (38.89%)    
Blood and lymphatic system disorders     
Hypercapnia *  0/80 (0.00%)  0 1/72 (1.39%)  1
Gastrointestinal disorders     
Headache or head pain *  2/80 (2.50%)  2 1/72 (1.39%)  1
Gastroenteritis, nausea, or vomiting *  1/80 (1.25%)  1 5/72 (6.94%)  5
General disorders     
Bacterial infection *  1/80 (1.25%)  1 0/72 (0.00%)  0
Vasovagal syncope *  1/80 (1.25%)  1 0/72 (0.00%)  0
Teeth chattering *  1/80 (1.25%)  1 0/72 (0.00%)  0
Dehydration *  1/80 (1.25%)  1 0/72 (0.00%)  0
Fever *  0/80 (0.00%)  0 1/72 (1.39%)  1
Flank pain *  0/80 (0.00%)  0 1/72 (1.39%)  1
Musculoskeletal and connective tissue disorders     
Muscle aches *  1/80 (1.25%)  1 0/72 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia *  3/80 (3.75%)  3 6/72 (8.33%)  6
Shortness of breath *  2/80 (2.50%)  2 4/72 (5.56%)  4
Low oxygen saturation or hypoxia *  0/80 (0.00%)  0 6/72 (8.33%)  6
Chest pain or tightness *  0/80 (0.00%)  0 2/72 (2.78%)  2
Acute respiratory failure *  0/80 (0.00%)  0 1/72 (1.39%)  1
*
Indicates events were collected by non-systematic assessment
It was a small study and was conducted within a single geographic area; there was a small number of end point events; it is possible that the differences in clinical deterioration may have been a reflection of the comparative baseline distributions of O2 saturation rather than an effect of treatment; the method of measuring the most severe baseline symptom over time did not appear to provide valid data; the follow-up was short; the 7-point scale created for this study has not been validated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Eric Lenze
Organization: Washington University School of Medicine
Phone: 314-362-5154
EMail: lenzee@wustl.edu
Layout table for additonal information
Responsible Party: Eric Lenze, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04342663    
Other Study ID Numbers: 202004023
First Submitted: April 8, 2020
First Posted: April 13, 2020
Results First Submitted: July 1, 2021
Results First Posted: July 9, 2021
Last Update Posted: July 9, 2021