Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2)

• ClinicalTrials.gov Identifier: NCT04668950
• Recruitment Status: Completed
• First Posted: December 16, 2020
• Results First Posted: October 18, 2022
• Last Update Posted: October 31, 2022
• Sponsor: Washington University School of Medicine
• Collaborators: Covid-19 Early Treatment Fund; McGill University Health Centre Department of Medicine Clinical Practice Assessment Unit; Cures Within Reach
• 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: Covid19; Coronavirus
• Interventions: Drug: Fluvoxamine; Drug: Placebo
• Enrollment: 670

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Fluvoxamine	Placebo
Arm/Group Description	Start fluvoxamine 50mg capsule once, then 100mg twice daily. May reduce dose for tolerability reasons. Will be followed in the RCT for approximately 15 days. Fluvoxamine: Up to 200mg per day (2 capsules per day) as tolerated, for approximately 15 days	Start placebo one capsule, twice daily. May reduce dose for tolerability reasons. Will be followed in RCT for approximately 15 days. Placebo: Will take 2 capsules per day as tolerated for approximately 15 days
Period Title: Overall Study
Started	334	336
Completed	272	275
Not Completed	62	61
Reason Not Completed
Started medication more than 7 days after symptom onset	18	14
Could not confirm started study medication	15	15
Could not confirm baseline status	6	2
Drop out and did not start medication	15	17
Deteriorated at or before baseline assessment	6	9
Other	2	4

Baseline Characteristics

Arm/Group Title		Fluvoxamine	Placebo	Total
Arm/Group Description		Start fluvoxamine 50mg capsule once, then 100mg twice daily. May reduce dose for tolerability reasons. Will be followed in the RCT for approximately 15 days. Fluvoxamine: Up to 200mg per day (2 capsules per day) as tolerated, for approximately 15 days	Start placebo one capsule, twice daily. May reduce dose for tolerability reasons. Will be followed in RCT for approximately 15 days. Placebo: Will take 2 capsules per day as tolerated for approximately 15 days	Total of all reporting groups
Overall Number of Baseline Participants		272	275	547
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Mean (Standard Deviation); Unit of measure: Years
Age	Number Analyzed	272 participants	275 participants	547 participants
		48 (10.18)	48 (9.83)	48 (10)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	272 participants	275 participants	547 participants
	Female	169 62.1%	170 61.8%	339 62.0%
	Male	103 37.9%	105 38.2%	208 38.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	272 participants	275 participants	547 participants
	Hispanic or Latino	35 12.9%	37 13.5%	72 13.2%
	Not Hispanic or Latino	234 86.0%	236 85.8%	470 85.9%
	Unknown or Not Reported	3 1.1%	2 0.7%	5 0.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	272 participants	275 participants	547 participants
American Indian/Alaskan Native		6 2.2%	8 2.9%	14 2.6%
Asian		8 2.9%	5 1.8%	13 2.4%
Black/African American		22 8.1%	23 8.4%	45 8.2%
White/Caucasian		197 72.4%	201 73.1%	398 72.8%
Native Hawaiian/Pacific Islander		4 1.5%	5 1.8%	9 1.6%
South Asian		3 1.1%	2 0.7%	5 0.9%
Unknown/Not reported		17 6.3%	22 8.0%	39 7.1%
Other (identified as other)		29 10.7%	21 7.6%	50 9.1%
SPO2 [1]; Mean (Standard Deviation); Unit of measure: mmHg
	Number Analyzed	272 participants	275 participants	547 participants
		96.8 (12.7)	96.8 (13.5)	96.8 (1.7)
		[1] Measure Description: This is a scale measuring your level of oxygen. A level of 95% or more is considered normal.
Duration of Covid-19 symptoms [1]; Mean (Standard Deviation); Unit of measure: Days
	Number Analyzed	272 participants	275 participants	547 participants
		5 (1.44)	4.8 (1.52)	4.9 (1.49)
		[1] Measure Description: How many days COVID-19 symptoms lasted at baseline.This would mean the number of days since the onset of symptoms at the time the participant enrolled.
Coexisting conditions; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	272 participants	275 participants	547 participants
Heart disease		4 1.5%	4 1.5%	8 1.5%
Lung disease		2 0.7%	2 0.7%	4 0.7%
Liver disease		1 0.4%	1 0.4%	2 0.4%
Kidney disease		1 0.4%	2 0.7%	3 0.5%
Hepatitis B/C		1 0.4%	1 0.4%	2 0.4%
Immune disorder		14 5.1%	4 1.5%	18 3.3%
HIV		1 0.4%	4 1.5%	5 0.9%
Asthma		40 14.7%	33 12.0%	73 13.3%
Hypertension		55 20.2%	62 22.5%	117 21.4%
Diabetes		23 8.5%	28 10.2%	51 9.3%
Active cancer		0 0.0%	1 0.4%	1 0.2%
Thyroid problem		20 7.4%	27 9.8%	47 8.6%
Other medical conditions		42 15.4%	54 19.6%	96 17.6%
Most severe COVID-19 symptom at baseline [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	272 participants	275 participants	547 participants
Loss of smell		74 27.2%	91 33.1%	165 30.2%
Fatigue		70 25.7%	59 21.5%	129 23.6%
Loss of taste		47 17.3%	48 17.5%	95 17.4%
Nasal congestion		45 16.5%	30 10.9%	75 13.7%
Cough		34 12.5%	37 13.5%	71 13.0%
Body aches		27 9.9%	30 10.9%	57 10.4%
Loss of appetite		21 7.7%	26 9.5%	47 8.6%
Subjective fever		12 4.4%	18 6.5%	30 5.5%
Nausea		11 4.0%	4 1.5%	15 2.7%
Chills		9 3.3%	10 3.6%	19 3.5%
Diarrhea		8 2.9%	9 3.3%	17 3.1%
Sore throat		8 2.9%	7 2.5%	15 2.7%
Shortness of breath		6 2.2%	7 2.5%	13 2.4%
		[1] Measure Description: Some people reported more than one symptom as their most severe symptom. This means some of the participants can be represented in more than one row.
Body Mass Index category (BMI) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	272 participants	275 participants	547 participants
	Less than 25	71 26.1%	62 22.5%	133 24.3%
	25-29.9	86 31.6%	90 32.7%	176 32.2%
	Greater than or equal to 30	115 42.3%	123 44.7%	238 43.5%
		[1] Measure Description: A BMI measurement of 25 and under means normal to underweight range. A measurement of 25-29.9 means overweight range. Measurements of 30 and over mean obese range.

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Clinical Deterioration
Description	Defined as the number of participants who experienced the following: both of the following: 1)Presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, 2)) decrease in O2 saturation (<92% on room air) and/or supplemental oxygen requirement to keep O2 saturation ≥92%).
Time Frame	RCT-approximately 15 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluvoxamine	Placebo
Arm/Group Description:	Start fluvoxamine 50mg capsule once, then 100mg twice daily. May reduce dose for tolerability reasons. Will be followed in the RCT for approximately 15 days. Fluvoxamine: Up to 200mg per day (2 capsules per day) as tolerated, for approximately 15 days	Start placebo one capsule, twice daily. May reduce dose for tolerability reasons. Will be followed in RCT for approximately 15 days. Placebo: Will take 2 capsules per day as tolerated for approximately 15 days
Overall Number of Participants Analyzed	272	275
Measure Type: Count of Participants; Unit of Measure: Participants
	13 4.8%	15 5.5%

Adverse Events

Time Frame	Approximately 90 days
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Fluvoxamine		Placebo
Arm/Group Description	Start fluvoxamine 50mg capsule once, then 100mg twice daily. May reduce dose for tolerability reasons. Will be followed in the RCT for approximately 15 days. Fluvoxamine: Up to 200mg per day (2 capsules per day) as tolerated, for approximately 15 days		Start placebo one capsule, twice daily. May reduce dose for tolerability reasons. Will be followed in RCT for approximately 15 days. Placebo: Will take 2 capsules per day as tolerated for approximately 15 days
All-Cause Mortality
	Fluvoxamine		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/272 (0.00%)		0/275 (0.00%)
Serious Adverse Events
	Fluvoxamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/272 (4.78%)		12/275 (4.36%)
General disorders
Appendicitis †	0/272 (0.00%)	0	1/275 (0.36%)	1
Bowel issues † [1]	1/272 (0.37%)	1	0/275 (0.00%)	0
Dry mouth †	1/272 (0.37%)	1	1/275 (0.36%)	1
Pulmonary embolism †	0/272 (0.00%)	0	1/275 (0.36%)	1
Vertigo † [2]	0/272 (0.00%)	0	1/275 (0.36%)	1
Infections and infestations
Pneumonia †	6/272 (2.21%)	6	1/275 (0.36%)	1
Worsening of COVID symptoms † [3]	1/272 (0.37%)	1	2/275 (0.73%)	2
Respiratory, thoracic and mediastinal disorders
Breathing problems † [4]	3/272 (1.10%)	3	5/275 (1.82%)	5
Skin and subcutaneous tissue disorders
Skin reaction † [5]	1/272 (0.37%)	1	0/275 (0.00%)	0
† Indicates events were collected by systematic assessment; [1] one instance of bowel blockage requiring hospitalization; [2] vertigo/vision problems; [3] requiring hospitalization; [4] including shortness of breath, and low oxygen; [5] one instance of staphylococcal skin/soft tissue infection of upper extremity requiring hospitalization.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Fluvoxamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/272 (5.51%)		5/275 (1.82%)
General disorders
Nausea/vomitting †	15/272 (5.51%)	15	5/275 (1.82%)	6
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Dr. Eric Lenze
• Organization: Washington University in St. Louis
• Phone: 314-362-5154
• EMail: lenzee@wustl.edu

• Responsible Party: Eric Lenze, Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04668950
• Other Study ID Numbers: 202011101
• First Submitted: December 11, 2020
• First Posted: December 16, 2020
• Results First Submitted: September 20, 2022
• Results First Posted: October 18, 2022
• Last Update Posted: October 31, 2022