Trial Outcomes & Findings for Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2) (NCT NCT04668950)
NCT ID: NCT04668950
Last Updated: 2022-10-31
Results Overview
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%).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
670 participants
Primary outcome timeframe
RCT-approximately 15 days
Results posted on
2022-10-31
Participant Flow
Participant milestones
| Measure |
Fluvoxamine
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
|
Placebo
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 Study
STARTED
|
334
|
336
|
|
Overall Study
COMPLETED
|
272
|
275
|
|
Overall Study
NOT COMPLETED
|
62
|
61
|
Reasons for withdrawal
| Measure |
Fluvoxamine
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
|
Placebo
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 Study
Started medication more than 7 days after symptom onset
|
18
|
14
|
|
Overall Study
Could not confirm started study medication
|
15
|
15
|
|
Overall Study
Could not confirm baseline status
|
6
|
2
|
|
Overall Study
Drop out and did not start medication
|
15
|
17
|
|
Overall Study
Deteriorated at or before baseline assessment
|
6
|
9
|
|
Overall Study
Other
|
2
|
4
|
Baseline Characteristics
Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2)
Baseline characteristics by cohort
| Measure |
Fluvoxamine
n=272 Participants
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
|
Placebo
n=275 Participants
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
n=547 Participants
Total of all reporting groups
|
|---|---|---|---|
|
SPO2
|
96.8 mmHg
STANDARD_DEVIATION 12.7 • n=5 Participants
|
96.8 mmHg
STANDARD_DEVIATION 13.5 • n=7 Participants
|
96.8 mmHg
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Duration of Covid-19 symptoms
|
5 days
STANDARD_DEVIATION 1.44 • n=5 Participants
|
4.8 days
STANDARD_DEVIATION 1.52 • n=7 Participants
|
4.9 days
STANDARD_DEVIATION 1.49 • n=5 Participants
|
|
Age, Customized
Age
|
48 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
48 years
STANDARD_DEVIATION 9.83 • n=7 Participants
|
48 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
339 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
234 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
470 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
197 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not reported
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other (identified as other)
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Coexisting conditions
Heart disease
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Coexisting conditions
Lung disease
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Coexisting conditions
Liver disease
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Coexisting conditions
Kidney disease
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Coexisting conditions
Hepatitis B/C
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Coexisting conditions
Immune disorder
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Coexisting conditions
HIV
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Coexisting conditions
Asthma
|
40 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Coexisting conditions
Hypertension
|
55 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Coexisting conditions
Diabetes
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Coexisting conditions
Active cancer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Coexisting conditions
Thyroid problem
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Coexisting conditions
Other medical conditions
|
42 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Loss of smell
|
74 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Fatigue
|
70 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Loss of taste
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Nasal congestion
|
45 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Cough
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Body aches
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Loss of appetite
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Subjective fever
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Nausea
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Chills
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Diarrhea
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Sore throat
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Most severe COVID-19 symptom at baseline
Shortness of breath
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Body Mass Index category (BMI)
Less than 25
|
71 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Body Mass Index category (BMI)
25-29.9
|
86 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Body Mass Index category (BMI)
Greater than or equal to 30
|
115 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: RCT-approximately 15 daysDefined 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%).
Outcome measures
| Measure |
Fluvoxamine
n=272 Participants
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
|
Placebo
n=275 Participants
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
|
|---|---|---|
|
Number of Participants With Clinical Deterioration
|
13 Participants
|
15 Participants
|
Adverse Events
Fluvoxamine
Serious events: 13 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 12 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluvoxamine
n=272 participants at risk
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
|
Placebo
n=275 participants at risk
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
|
|---|---|---|
|
General disorders
Appendicitis
|
0.00%
0/272 • Approximately 90 days
|
0.36%
1/275 • Number of events 1 • Approximately 90 days
|
|
General disorders
Bowel issues
|
0.37%
1/272 • Number of events 1 • Approximately 90 days
|
0.00%
0/275 • Approximately 90 days
|
|
General disorders
Dry mouth
|
0.37%
1/272 • Number of events 1 • Approximately 90 days
|
0.36%
1/275 • Number of events 1 • Approximately 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Breathing problems
|
1.1%
3/272 • Number of events 3 • Approximately 90 days
|
1.8%
5/275 • Number of events 5 • Approximately 90 days
|
|
Infections and infestations
Pneumonia
|
2.2%
6/272 • Number of events 6 • Approximately 90 days
|
0.36%
1/275 • Number of events 1 • Approximately 90 days
|
|
General disorders
Pulmonary embolism
|
0.00%
0/272 • Approximately 90 days
|
0.36%
1/275 • Number of events 1 • Approximately 90 days
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.37%
1/272 • Number of events 1 • Approximately 90 days
|
0.00%
0/275 • Approximately 90 days
|
|
General disorders
Vertigo
|
0.00%
0/272 • Approximately 90 days
|
0.36%
1/275 • Number of events 1 • Approximately 90 days
|
|
Infections and infestations
Worsening of COVID symptoms
|
0.37%
1/272 • Number of events 1 • Approximately 90 days
|
0.73%
2/275 • Number of events 2 • Approximately 90 days
|
Other adverse events
| Measure |
Fluvoxamine
n=272 participants at risk
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
|
Placebo
n=275 participants at risk
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
|
|---|---|---|
|
General disorders
Nausea/vomitting
|
5.5%
15/272 • Number of events 15 • Approximately 90 days
|
1.8%
5/275 • Number of events 6 • Approximately 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place