Trial Outcomes & Findings for COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19) (NCT NCT04510194)

NCT ID: NCT04510194

Last Updated: 2024-05-16

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1323 participants

Primary outcome timeframe

14 days

Results posted on

2024-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm - Metformin Only Group Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the metformin alone. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14.	Treatment Arm - Placebo Group Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the placebo. Placebo: placebo; appearance and size are exact matching to the three study drugs.	Treatment Arm - Ivermectin Only Group Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the ivermectin alone. Ivermectin: An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days	Treatment Arm - Fluvoxamine Only Group Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the fluvoxamine alone. Fluvoxamine: An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14	Treatment Arm - Metformin and Fluvoxamine Group Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and fluvoxamine. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14. Fluvoxamine: An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14	Treatment Arm - Metformin and Ivermectin Group Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and ivermectin. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14. Ivermectin: An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days
Overall Study STARTED	284	295	206	159	175	204
Overall Study COMPLETED	278	291	206	156	173	201
Overall Study NOT COMPLETED	6	4	0	3	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm - Metformin Only Group n=284 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the metformin alone. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14.	Treatment Arm - Placebo Group n=295 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the placebo. Placebo: placebo; appearance and size are exact matching to the three study drugs.	Treatment Arm - Ivermectin Only Group n=206 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the ivermectin alone. Ivermectin: An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days	Treatment Arm - Fluvoxamine Only Group n=159 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the fluvoxamine alone. Fluvoxamine: An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14	Treatment Arm - Metformin and Fluvoxamine Group n=175 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and fluvoxamine. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14. Fluvoxamine: An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14	Treatment Arm - Metformin and Ivermectin Group n=204 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and ivermectin. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14. Ivermectin: An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days	Total n=1323 Participants Total of all reporting groups
Age, Continuous	46 years n=5 Participants	42 years n=7 Participants	48 years n=5 Participants	46 years n=4 Participants	46 years n=21 Participants	46 years n=10 Participants	46 years n=115 Participants
Sex: Female, Male Female	168 Participants n=5 Participants	187 Participants n=7 Participants	108 Participants n=5 Participants	87 Participants n=4 Participants	83 Participants n=21 Participants	108 Participants n=10 Participants	741 Participants n=115 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	108 Participants n=7 Participants	98 Participants n=5 Participants	72 Participants n=4 Participants	92 Participants n=21 Participants	96 Participants n=10 Participants	582 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	18 Participants n=115 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	7 Participants n=10 Participants	38 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants	14 Participants n=21 Participants	13 Participants n=10 Participants	87 Participants n=115 Participants
Race (NIH/OMB) White	213 Participants n=5 Participants	238 Participants n=7 Participants	151 Participants n=5 Participants	125 Participants n=4 Participants	141 Participants n=21 Participants	154 Participants n=10 Participants	1022 Participants n=115 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=10 Participants	30 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	29 Participants n=5 Participants	23 Participants n=7 Participants	28 Participants n=5 Participants	8 Participants n=4 Participants	12 Participants n=21 Participants	23 Participants n=10 Participants	123 Participants n=115 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	Treatment Arm - Metformin Only Group n=278 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the metformin alone. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14.	Treatment Arm - Placebo Group n=291 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the placebo. Placebo: placebo; appearance and size are exact matching to the three study drugs.	Treatment Arm - Ivermectin Only Group n=206 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the ivermectin alone. Ivermectin: An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days	Treatment Arm - Fluvoxamine Only Group n=156 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the fluvoxamine alone. Fluvoxamine: An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14	Treatment Arm - Metformin and Fluvoxamine Group n=173 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and fluvoxamine. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14. Fluvoxamine: An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14	Treatment Arm - Metformin and Ivermectin Group n=201 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and ivermectin. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14. Ivermectin: An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days
Count of Participants With Hypoxia Only	147 Participants	158 Participants	88 Participants	73 Participants	71 Participants	96 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	Treatment Arm - Metformin Only Group n=278 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the metformin alone. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14.	Treatment Arm - Placebo Group n=291 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the placebo. Placebo: placebo; appearance and size are exact matching to the three study drugs.	Treatment Arm - Ivermectin Only Group n=206 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the ivermectin alone. Ivermectin: An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days	Treatment Arm - Fluvoxamine Only Group n=156 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the fluvoxamine alone. Fluvoxamine: An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14	Treatment Arm - Metformin and Fluvoxamine Group n=173 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and fluvoxamine. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14. Fluvoxamine: An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14	Treatment Arm - Metformin and Ivermectin Group n=201 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and ivermectin. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14. Ivermectin: An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days
Count of Participants With ED Visit, Hospitalization or Death	27 Participants	48 Participants	16 Participants	15 Participants	18 Participants	23 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	Treatment Arm - Metformin Only Group n=278 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the metformin alone. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14.	Treatment Arm - Placebo Group n=291 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the placebo. Placebo: placebo; appearance and size are exact matching to the three study drugs.	Treatment Arm - Ivermectin Only Group n=206 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the ivermectin alone. Ivermectin: An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days	Treatment Arm - Fluvoxamine Only Group n=156 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive the fluvoxamine alone. Fluvoxamine: An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14	Treatment Arm - Metformin and Fluvoxamine Group n=173 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and fluvoxamine. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14. Fluvoxamine: An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14	Treatment Arm - Metformin and Ivermectin Group n=201 Participants Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in this arm and group will receive metformin and ivermectin. Metformin: Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14. Ivermectin: An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days
Count of Participants With Hospitalization or Death	8 Participants	18 Participants	5 Participants	5 Participants	6 Participants	4 Participants

PRIMARY outcome

Timeframe: 14 days