Trial Outcomes & Findings for ACTIV-6: COVID-19 Study of Repurposed Medications (NCT NCT04885530)

Last Updated: 2025-11-17

Results Overview

Total number of participants randomized within each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT ID.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

10956 participants

Primary outcome timeframe

Up to approximately 2 years 10 months

Results posted on

2025-11-17

Participant Flow

Numbers reported represent those who were eligible for study drug and randomized. Participants who were randomized to a placebo group may have participated in more than one study arm due to the nature of the study design.

Participant milestones

Participant milestones
Measure	Arm A - Ivermectin 400 Ivermectin - 7-mg tablets or Placebo Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg. Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.	Arm B - Fluvoxamine Fluvoxamine or Placebo will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days. Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.	Arm C - Fluticasone Fluticasone or Placebo is a self-administered inhaled drug. Participants will self-administer 200 µg (1 blister) of fluticasone once daily for 14 days. After inhaler activation, the powder within the blister is exposed and the participant inhales the study drug through the mouthpiece. Fluticasone: Fluticasone furoate is an inhaled powder drug product composed of fluticasone furoate. It is a synthetic trifluorinated corticosteroid that is insoluble in water. Fluticasone furoate is a white powder and will be provided in a two tone grey inhaler with a mouthpiece cover and separate foil blister strips. The inhaler will be packaged in a moisture-protective foil tray with a desiccant and a peelable lid.All packaging will be labeled to indicate that the product is for investigational use. Participants will self-administer 200 µg (1 blister) of fluticasone furoate once daily for 14 days.	Arm D - Ivermectin 600 Ivermectin - 7-mg tablets or Placebo Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 µg/kg. Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.	Arm E - Fluvoxamine 100 Fluvoxamine or Placebo will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days. Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.	Arm F - Montelukast Montelukast or Placebo will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days. Montelukast: Montelukast sodium is a white to off-white powder. The 10 mg montelukast tablets are beige, rounded square-shaped, biconvex, film-coated tablets. Each tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg montelukast. All packaging will be labeled to indicate that the product is for investigational use.	Arm G - Metformin Metformin IR tablets or Placebo will be self-administered orally according to the following dosing schedule: * 500 mg on Day 1; * 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and * 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14. Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
Substudy A STARTED	1800	0	0	0	0	0	0
Substudy A COMPLETED	1800	0	0	0	0	0	0
Substudy A NOT COMPLETED	0	0	0	0	0	0	0
Substudy B STARTED	0	1331	0	0	0	0	0
Substudy B COMPLETED	0	1331	0	0	0	0	0
Substudy B NOT COMPLETED	0	0	0	0	0	0	0
Substudy C STARTED	0	0	1407	0	0	0	0
Substudy C COMPLETED	0	0	1407	0	0	0	0
Substudy C NOT COMPLETED	0	0	0	0	0	0	0
Substudy D STARTED	0	0	0	1459	0	0	0
Substudy D COMPLETED	0	0	0	1459	0	0	0
Substudy D NOT COMPLETED	0	0	0	0	0	0	0
Substudy E STARTED	0	0	0	0	1208	0	0
Substudy E COMPLETED	0	0	0	0	1208	0	0
Substudy E NOT COMPLETED	0	0	0	0	0	0	0
Substudy F STARTED	0	0	0	0	0	1453	0
Substudy F COMPLETED	0	0	0	0	0	1453	0
Substudy F NOT COMPLETED	0	0	0	0	0	0	0
Substudy G STARTED	0	0	0	0	0	0	3214
Substudy G COMPLETED	0	0	0	0	0	0	3214
Substudy G NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data reported for each substudy/arm separately as some placebo participants were shared among substudies.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - Ivermectin 400 n=1800 Participants Ivermectin - 7-mg tablets or Placebo Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg. Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.	Arm B - Fluvoxamine n=1331 Participants Fluvoxamine or Placebo will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days. Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.	Arm C - Fluticasone n=1407 Participants Fluticasone or Placebo is a self-administered inhaled drug. Participants will self-administer 200 µg (1 blister) of fluticasone once daily for 14 days. After inhaler activation, the powder within the blister is exposed and the participant inhales the study drug through the mouthpiece. Fluticasone: Fluticasone furoate is an inhaled powder drug product composed of fluticasone furoate. It is a synthetic trifluorinated corticosteroid that is insoluble in water. Fluticasone furoate is a white powder and will be provided in a two tone grey inhaler with a mouthpiece cover and separate foil blister strips. The inhaler will be packaged in a moisture-protective foil tray with a desiccant and a peelable lid.All packaging will be labeled to indicate that the product is for investigational use. Participants will self-administer 200 µg (1 blister) of fluticasone furoate once daily for 14 days.	Arm D - Ivermectin 600 n=1459 Participants Ivermectin - 7-mg tablets or Placebo Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 µg/kg. Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.	Arm E - Fluvoxamine 100 n=1208 Participants Fluvoxamine or Placebo will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days. Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.	Arm F - Montelukast n=1453 Participants Montelukast or Placebo will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days. Montelukast: Montelukast sodium is a white to off-white powder. The 10 mg montelukast tablets are beige, rounded square-shaped, biconvex, film-coated tablets. Each tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg montelukast. All packaging will be labeled to indicate that the product is for investigational use.	Arm G - Metformin n=3214 Participants Metformin IR tablets or Placebo will be self-administered orally according to the following dosing schedule: * 500 mg on Day 1; * 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and * 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14. Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.	Total n=11872 Participants Total of all reporting groups
Race/Ethnicity, Customized Substudy F: Race · American Indian or Alaska Native	—	—	—	—	—	3 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	3 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy E: Race · American Indian or Alaska Native	—	—	—	—	7 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	7 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy E: Race · Asian	—	—	—	—	50 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	50 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy E: Race · Black, African American, or African	—	—	—	—	104 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	104 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy E: Race · Middle Eastern or North African	—	—	—	—	59 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	59 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy E: Race · Native Hawaiian or Other Pacific Islander	—	—	—	—	2 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	2 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy E: Race · White	—	—	—	—	847 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	847 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy E: Race · More than one race	—	—	—	—	31 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	31 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy E: Race · None of the above	—	—	—	—	74 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	74 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy E: Race · Prefer not to answer	—	—	—	—	27 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	27 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy E: Race · No response	—	—	—	—	7 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	7 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy F: Race · Asian	—	—	—	—	—	44 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	44 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy F: Race · Black, African American, or African	—	—	—	—	—	177 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	177 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy F: Race · Middle Eastern or North African	—	—	—	—	—	24 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	24 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy F: Race · Native Hawaiian or Other Pacific Islander	—	—	—	—	—	2 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	2 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy F: Race · White	—	—	—	—	—	1121 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	1121 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy F: Race · More than one race	—	—	—	—	—	17 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	17 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy F: Race · None of the above	—	—	—	—	—	45 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	45 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy F: Race · Prefer not to answer	—	—	—	—	—	16 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	16 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy F: Race · No response	—	—	—	—	—	4 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	4 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy G: Race · American Indian or Alaska Native	—	—	—	—	—	—	12 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	12 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy G: Race · Asian	—	—	—	—	—	—	68 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	68 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy G: Race · Black, African American, or African	—	—	—	—	—	—	433 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	433 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy G: Race · Middle Eastern or North African	—	—	—	—	—	—	49 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	49 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy G: Race · Native Hawaiian or Other Pacific Islander	—	—	—	—	—	—	4 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	4 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy G: Race · White	—	—	—	—	—	—	2445 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	2445 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy G: Race · More than one race	—	—	—	—	—	—	57 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	57 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy G: Race · None of the above	—	—	—	—	—	—	72 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	72 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy G: Race · Prefer not to answer	—	—	—	—	—	—	60 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	60 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy G: Race · No response	—	—	—	—	—	—	14 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	14 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Age, Continuous Substudy A	47 years n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	47 years n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Age, Continuous Substudy B	—	47 years n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	47 years n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Age, Continuous Substudy C	—	—	45 years n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	45 years n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Age, Continuous Substudy D	—	—	—	48 years n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	48 years n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Age, Continuous Substudy E	—	—	—	—	50 years n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	50 years n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Age, Continuous Substudy F	—	—	—	—	—	52 years n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	52 years n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Age, Continuous Substudy G	—	—	—	—	—	—	47 years n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	47 years n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy A: Sex/Gender · Female	1049 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	1049 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy A: Sex/Gender · Male	749 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	749 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy A: Sex/Gender · Undifferentiated	0 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	0 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy A: Sex/Gender · Unknown	1 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	1 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy A: Sex/Gender · Prefer Not to Answer the Question	1 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	1 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy B: Sex/Gender · Female	—	755 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	755 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy B: Sex/Gender · Male	—	571 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	571 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy B: Sex/Gender · Undifferentiated	—	0 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	0 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy B: Sex/Gender · Unknown	—	2 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	2 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy B: Sex/Gender · Prefer Not to Answer the Question	—	3 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	3 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy C: Sex/Gender · Female	—	—	875 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	875 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy C: Sex/Gender · Male	—	—	528 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	528 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy C: Sex/Gender · Undifferentiated	—	—	1 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	1 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy C: Sex/Gender · Unknown	—	—	2 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	2 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy C: Sex/Gender · Prefer Not to Answer the Question	—	—	1 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	1 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy D: Sex/Gender · Female	—	—	—	871 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	871 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy D: Sex/Gender · Male	—	—	—	583 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	583 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy D: Sex/Gender · Undifferentiated	—	—	—	3 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	3 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy D: Sex/Gender · Unknown	—	—	—	1 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	1 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy D: Sex/Gender · Prefer Not to Answer the Question	—	—	—	1 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	1 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy E: Sex/Gender · Female	—	—	—	—	794 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	794 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy E: Sex/Gender · Male	—	—	—	—	414 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	414 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy E: Sex/Gender · Undifferentiated	—	—	—	—	0 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	0 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy E: Sex/Gender · Unknown	—	—	—	—	0 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	0 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy E: Sex/Gender · Prefer Not to Answer the Question	—	—	—	—	0 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	0 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy F: Sex/Gender · Female	—	—	—	—	—	872 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	872 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy F: Sex/Gender · Male	—	—	—	—	—	581 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	581 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy F: Sex/Gender · Undifferentiated	—	—	—	—	—	0 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	0 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy F: Sex/Gender · Unknown	—	—	—	—	—	0 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	0 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy F: Sex/Gender · Prefer Not to Answer the Question	—	—	—	—	—	0 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	0 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy G: Sex/Gender · Female	—	—	—	—	—	—	2021 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	2021 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy G: Sex/Gender · Male	—	—	—	—	—	—	1185 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	1185 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy G: Sex/Gender · Undifferentiated	—	—	—	—	—	—	2 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	2 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy G: Sex/Gender · Unknown	—	—	—	—	—	—	3 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	3 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Sex/Gender, Customized Substudy G: Sex/Gender · Prefer Not to Answer the Question	—	—	—	—	—	—	3 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	3 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy A · Hispanic or Latino	186 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	186 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy A · Not Hispanic or Latino	1614 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	1614 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy A · Unknown or Not Reported	0 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	0 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy B · Hispanic or Latino	—	224 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	224 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy B · Not Hispanic or Latino	—	1106 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	1106 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy B · Unknown or Not Reported	—	1 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	1 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy C · Hispanic or Latino	—	—	177 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	177 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy C · Not Hispanic or Latino	—	—	1229 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	1229 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy C · Unknown or Not Reported	—	—	1 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	1 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy D · Hispanic or Latino	—	—	—	311 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	311 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy D · Not Hispanic or Latino	—	—	—	1147 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	1147 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy D · Unknown or Not Reported	—	—	—	1 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	1 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy E · Hispanic or Latino	—	—	—	—	552 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	552 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy E · Not Hispanic or Latino	—	—	—	—	656 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	656 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy E · Unknown or Not Reported	—	—	—	—	0 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	0 Participants n=1208 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy F · Hispanic or Latino	—	—	—	—	—	935 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	935 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy F · Not Hispanic or Latino	—	—	—	—	—	518 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	518 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy F · Unknown or Not Reported	—	—	—	—	—	0 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	0 Participants n=1453 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy G · Hispanic or Latino	—	—	—	—	—	—	1467 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	1467 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy G · Not Hispanic or Latino	—	—	—	—	—	—	1747 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	1747 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Ethnicity (NIH/OMB) Substudy G · Unknown or Not Reported	—	—	—	—	—	—	0 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	0 Participants n=3214 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy A: Race · American Indian or Alaska Native	19 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	19 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy A: Race · Asian	35 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	35 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy A: Race · Black, African American, or African	127 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	127 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy A: Race · Middle Eastern or North African	81 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	81 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy A: Race · Native Hawaiian or Other Pacific Islander	3 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	3 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy A: Race · White	1394 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	1394 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy A: Race · More than one race	29 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	29 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy A: Race · None of the above	50 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	50 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy A: Race · Prefer not to answer	42 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	42 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy A: Race · No response	20 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	—	20 Participants n=1800 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy B: Race · American Indian or Alaska Native	—	4 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	4 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy B: Race · Asian	—	75 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	75 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy B: Race · Black, African American, or African	—	96 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	96 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy B: Race · Middle Eastern or North African	—	7 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	7 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy B: Race · Native Hawaiian or Other Pacific Islander	—	1 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	1 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy B: Race · White	—	1041 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	1041 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy B: Race · More than one race	—	30 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	30 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy B: Race · None of the above	—	43 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	43 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy B: Race · Prefer not to answer	—	23 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	23 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy B: Race · No response	—	11 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	—	11 Participants n=1331 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy C: Race · American Indian or Alaska Native	—	—	7 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	7 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy C: Race · Asian	—	—	67 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	67 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy C: Race · Black, African American, or African	—	—	101 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	101 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy C: Race · Middle Eastern or North African	—	—	35 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	35 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy C: Race · Native Hawaiian or Other Pacific Islander	—	—	2 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	2 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy C: Race · White	—	—	1079 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	1079 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy C: Race · More than one race	—	—	23 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	23 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy C: Race · None of the above	—	—	50 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	50 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy C: Race · Prefer not to answer	—	—	33 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	33 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy C: Race · No response	—	—	10 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	—	10 Participants n=1407 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy D: Race · American Indian or Alaska Native	—	—	—	10 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	10 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy D: Race · Asian	—	—	—	92 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	92 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy D: Race · Black, African American, or African	—	—	—	111 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	111 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy D: Race · Middle Eastern or North African	—	—	—	59 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	59 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy D: Race · Native Hawaiian or Other Pacific Islander	—	—	—	5 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	5 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy D: Race · White	—	—	—	1029 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	1029 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy D: Race · More than one race	—	—	—	31 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	31 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy D: Race · None of the above	—	—	—	80 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	80 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy D: Race · Prefer not to answer	—	—	—	37 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	37 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.
Race/Ethnicity, Customized Substudy D: Race · No response	—	—	—	5 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.	—	—	—	5 Participants n=1459 Participants • Data reported for each substudy/arm separately as some placebo participants were shared among substudies.

PRIMARY outcome

Timeframe: Up to approximately 2 years 10 months

Population: Individuals who met inclusion criteria and consented for study drug for each study arm. Given that participants were not randomized at this point, one number is reported for each study arm as a whole.

Total number of participants randomized within each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT ID.

Outcome measures

Outcome measures
Measure	Arm A - Ivermectin 400 n=3457 Participants Ivermectin - 7-mg tablets or Placebo Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg. Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.	Arm B - Fluvoxamine n=3837 Participants Fluvoxamine or Placebo will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days. Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.	Arm C - Fluticasone n=3315 Participants Fluticasone or Placebo is a self-administered inhaled drug. Participants will self-administer 200 µg (1 blister) of fluticasone once daily for 14 days. After inhaler activation, the powder within the blister is exposed and the participant inhales the study drug through the mouthpiece. Fluticasone: Fluticasone furoate is an inhaled powder drug product composed of fluticasone furoate. It is a synthetic trifluorinated corticosteroid that is insoluble in water. Fluticasone furoate is a white powder and will be provided in a two tone grey inhaler with a mouthpiece cover and separate foil blister strips. The inhaler will be packaged in a moisture-protective foil tray with a desiccant and a peelable lid.All packaging will be labeled to indicate that the product is for investigational use. Participants will self-administer 200 µg (1 blister) of fluticasone furoate once daily for 14 days.	Arm D - Ivermectin 600 n=2212 Participants Ivermectin - 7-mg tablets or Placebo Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 µg/kg. Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.	Arm E - Fluvoxamine 100 n=1657 Participants Fluvoxamine or Placebo will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days. Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.	Arm F - Montelukast n=1660 Participants Montelukast or Placebo will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days. Montelukast: Montelukast sodium is a white to off-white powder. The 10 mg montelukast tablets are beige, rounded square-shaped, biconvex, film-coated tablets. Each tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg montelukast. All packaging will be labeled to indicate that the product is for investigational use.	Arm G - Metformin n=3704 Participants Metformin IR tablets or Placebo will be self-administered orally according to the following dosing schedule: * 500 mg on Day 1; * 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and * 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14. Metformin: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
Total Number of Participants Randomized Within Each Appendix	1800 Participants	1331 Participants	1407 Participants	1459 Participants	1208 Participants	1453 Participants	3214 Participants

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susanna Naggie, MD, MHS, FIDSA

Duke University

Phone: 919-684-2584

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place