Covid19
Conditions
Keywords
SARS-CoV-2, COVID-19, ivermectin, Placebo, Duke University Health System, Outcomes, Duke Clinical Research Institute, fluticasone, fluvoxamine, ACTIV 6, ACTIV, montelukast, metformin
Brief summary
The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person. Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include Pro00107921 in the Unique Protocol ID. Pro00107921\_A - Arm D (Ivermectin 400) - NCT05736861; Pro00107921\_B - Arm B (Fluvoxamine) - NCT05890586; Pro00107921\_C - Arm C (Fluticasone) - NCT05736874; Pro00107921\_D - Arm D (Ivermectin 600) - NCT05894538; Pro00107921\_E - Arm E (Fluvoxamine 100) - NCT05894564; Pro00107921\_F - Arm F (Montelukast) - NCT05894577; Pro00107921\_G - Arm G (Metformin) - NCT06042855.
Detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. The clinical disease related to SARS-CoV-2 is referred to as Coronavirus Disease 2019 (COVID-19). Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the treatment of COVID-19 infection in the outpatient setting. This proposed platform protocol can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19. The ultimate goal is to evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization. This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within healthcare systems and in community settings where it can be integrated into routine COVID-19 testing programs and subsequent treatment plans. This platform protocol will enroll participants in an outpatient setting with a confirmed polymerase chain reaction (PCR) or antigen test for SARS-CoV-2. Participants will be randomized to study drugs or placebo based on the arms that are actively enrolling at the time of randomization. Study drugs may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study drugs available, randomization will occur based on appropriateness of each drug for the participant as determined by the study protocol and investigator and participant equipoise. Each participant will be required to randomize to at least one study drug versus placebo. The probability of placebo to treatment will remain the same regardless of eligibility decisions. Eligible participants will be randomized (1:1), in a blinded fashion, to either the study drug arm or placebo arm in addition to standard of care. As additional study drugs are added, the randomization will be altered to leverage placebo data across arms. Participants will receive a complete supply study drug or placebo with the quantity depending on the study drug/placebo to which they are randomized. All study visits are designed to be remote. However, screening and enrollment may occur in-person at sites and unplanned study visits may occur in-person or remotely, as deemed appropriate by the site investigator for safety purposes. Participants will be asked to complete questionnaires and report safety events during the study. Participants will be prompted by the online system to report safety events and these will be reviewed and confirmed via medical records and site staff, as necessary.
Interventions
DRUGIvermectin
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.
DRUGFluvoxamine
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.
DRUGFluticasone
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.
OTHERPlacebo
Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
DRUGMontelukast
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.
DRUGMetformin
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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Vanderbilt University Medical Center
Susanna Naggie, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The participant and study teams will know which study drug the participant is allocated to, but will be blinded to study drug versus placebo because they will be matching.
Intervention model description
Double-Blind, Placebo-Controlled, Randomized Trial
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility for overall study are listed below. There may be additional appendix-specific criteria. Inclusion Criteria: * Completed Informed Consent * Age ≥ 30 years old * Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening * Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
Exclusion criteria
* Current or recent (within 10 days of screening) hospitalization for COVID-19 infection * Current or planned participation in another interventional trial to treat COVID-19, at the discretion of the study principal investigator (PI) * Current or recent use (within the last 14 days) of study drug or study drug/device combination * Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo * Known contraindication(s) to study drug including prohibited concomitant medications * Previous or current enrollment in the ACTIV-6 trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Participants Randomized Within Each Appendix | Up to approximately 2 years 10 months | Total number of participants randomized within each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT ID. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,800 |
| 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. | 1,331 |
| 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. | 1,407 |
| 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. | 1,459 |
| 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. | 1,208 |
| 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. | 1,453 |
| 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. | 3,214 |
| Total | 11,872 |
Baseline characteristics
| Characteristic | Arm A - Ivermectin 400 | Total | Arm B - Fluvoxamine | Arm C - Fluticasone | Arm D - Ivermectin 600 | Arm E - Fluvoxamine 100 | Arm F - Montelukast | Arm G - Metformin |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous Substudy A | 47 years | 47 years | — | — | — | — | — | — |
| Age, Continuous Substudy B | — | 47 years | 47 years | — | — | — | — | — |
| Age, Continuous Substudy C | — | 45 years | — | 45 years | — | — | — | — |
| Age, Continuous Substudy D | — | 48 years | — | — | 48 years | — | — | — |
| Age, Continuous Substudy E | — | 50 years | — | — | — | 50 years | — | — |
| Age, Continuous Substudy F | — | 52 years | — | — | — | — | 52 years | — |
| Age, Continuous Substudy G | — | 47 years | — | — | — | — | — | 47 years |
| Ethnicity (NIH/OMB) Substudy A Hispanic or Latino | 186 Participants | 186 Participants | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Substudy A Not Hispanic or Latino | 1614 Participants | 1614 Participants | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Substudy A Unknown or Not Reported | 0 Participants | 0 Participants | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Substudy B Hispanic or Latino | — | 224 Participants | 224 Participants | — | — | — | — | — |
| Ethnicity (NIH/OMB) Substudy B Not Hispanic or Latino | — | 1106 Participants | 1106 Participants | — | — | — | — | — |
| Ethnicity (NIH/OMB) Substudy B Unknown or Not Reported | — | 1 Participants | 1 Participants | — | — | — | — | — |
| Ethnicity (NIH/OMB) Substudy C Hispanic or Latino | — | 177 Participants | — | 177 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Substudy C Not Hispanic or Latino | — | 1229 Participants | — | 1229 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Substudy C Unknown or Not Reported | — | 1 Participants | — | 1 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Substudy D Hispanic or Latino | — | 311 Participants | — | — | 311 Participants | — | — | — |
| Ethnicity (NIH/OMB) Substudy D Not Hispanic or Latino | — | 1147 Participants | — | — | 1147 Participants | — | — | — |
| Ethnicity (NIH/OMB) Substudy D Unknown or Not Reported | — | 1 Participants | — | — | 1 Participants | — | — | — |
| Ethnicity (NIH/OMB) Substudy E Hispanic or Latino | — | 552 Participants | — | — | — | 552 Participants | — | — |
| Ethnicity (NIH/OMB) Substudy E Not Hispanic or Latino | — | 656 Participants | — | — | — | 656 Participants | — | — |
| Ethnicity (NIH/OMB) Substudy E Unknown or Not Reported | — | 0 Participants | — | — | — | 0 Participants | — | — |
| Ethnicity (NIH/OMB) Substudy F Hispanic or Latino | — | 935 Participants | — | — | — | — | 935 Participants | — |
| Ethnicity (NIH/OMB) Substudy F Not Hispanic or Latino | — | 518 Participants | — | — | — | — | 518 Participants | — |
| Ethnicity (NIH/OMB) Substudy F Unknown or Not Reported | — | 0 Participants | — | — | — | — | 0 Participants | — |
| Ethnicity (NIH/OMB) Substudy G Hispanic or Latino | — | 1467 Participants | — | — | — | — | — | 1467 Participants |
| Ethnicity (NIH/OMB) Substudy G Not Hispanic or Latino | — | 1747 Participants | — | — | — | — | — | 1747 Participants |
| Ethnicity (NIH/OMB) Substudy G Unknown or Not Reported | — | 0 Participants | — | — | — | — | — | 0 Participants |
| Race/Ethnicity, Customized Substudy A: Race American Indian or Alaska Native | 19 Participants | 19 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy A: Race Asian | 35 Participants | 35 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy A: Race Black, African American, or African | 127 Participants | 127 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy A: Race Middle Eastern or North African | 81 Participants | 81 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy A: Race More than one race | 29 Participants | 29 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy A: Race Native Hawaiian or Other Pacific Islander | 3 Participants | 3 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy A: Race None of the above | 50 Participants | 50 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy A: Race No response | 20 Participants | 20 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy A: Race Prefer not to answer | 42 Participants | 42 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy A: Race White | 1394 Participants | 1394 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy B: Race American Indian or Alaska Native | — | 4 Participants | 4 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy B: Race Asian | — | 75 Participants | 75 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy B: Race Black, African American, or African | — | 96 Participants | 96 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy B: Race Middle Eastern or North African | — | 7 Participants | 7 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy B: Race More than one race | — | 30 Participants | 30 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy B: Race Native Hawaiian or Other Pacific Islander | — | 1 Participants | 1 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy B: Race None of the above | — | 43 Participants | 43 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy B: Race No response | — | 11 Participants | 11 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy B: Race Prefer not to answer | — | 23 Participants | 23 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy B: Race White | — | 1041 Participants | 1041 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Substudy C: Race American Indian or Alaska Native | — | 7 Participants | — | 7 Participants | — | — | — | — |
| Race/Ethnicity, Customized Substudy C: Race Asian | — | 67 Participants | — | 67 Participants | — | — | — | — |
| Race/Ethnicity, Customized Substudy C: Race Black, African American, or African | — | 101 Participants | — | 101 Participants | — | — | — | — |
| Race/Ethnicity, Customized Substudy C: Race Middle Eastern or North African | — | 35 Participants | — | 35 Participants | — | — | — | — |
| Race/Ethnicity, Customized Substudy C: Race More than one race | — | 23 Participants | — | 23 Participants | — | — | — | — |
| Race/Ethnicity, Customized Substudy C: Race Native Hawaiian or Other Pacific Islander | — | 2 Participants | — | 2 Participants | — | — | — | — |
| Race/Ethnicity, Customized Substudy C: Race None of the above | — | 50 Participants | — | 50 Participants | — | — | — | — |
| Race/Ethnicity, Customized Substudy C: Race No response | — | 10 Participants | — | 10 Participants | — | — | — | — |
| Race/Ethnicity, Customized Substudy C: Race Prefer not to answer | — | 33 Participants | — | 33 Participants | — | — | — | — |
| Race/Ethnicity, Customized Substudy C: Race White | — | 1079 Participants | — | 1079 Participants | — | — | — | — |
| Race/Ethnicity, Customized Substudy D: Race American Indian or Alaska Native | — | 10 Participants | — | — | 10 Participants | — | — | — |
| Race/Ethnicity, Customized Substudy D: Race Asian | — | 92 Participants | — | — | 92 Participants | — | — | — |
| Race/Ethnicity, Customized Substudy D: Race Black, African American, or African | — | 111 Participants | — | — | 111 Participants | — | — | — |
| Race/Ethnicity, Customized Substudy D: Race Middle Eastern or North African | — | 59 Participants | — | — | 59 Participants | — | — | — |
| Race/Ethnicity, Customized Substudy D: Race More than one race | — | 31 Participants | — | — | 31 Participants | — | — | — |
| Race/Ethnicity, Customized Substudy D: Race Native Hawaiian or Other Pacific Islander | — | 5 Participants | — | — | 5 Participants | — | — | — |
| Race/Ethnicity, Customized Substudy D: Race None of the above | — | 80 Participants | — | — | 80 Participants | — | — | — |
| Race/Ethnicity, Customized Substudy D: Race No response | — | 5 Participants | — | — | 5 Participants | — | — | — |
| Race/Ethnicity, Customized Substudy D: Race Prefer not to answer | — | 37 Participants | — | — | 37 Participants | — | — | — |
| Race/Ethnicity, Customized Substudy D: Race White | — | 1029 Participants | — | — | 1029 Participants | — | — | — |
| Race/Ethnicity, Customized Substudy E: Race American Indian or Alaska Native | — | 7 Participants | — | — | — | 7 Participants | — | — |
| Race/Ethnicity, Customized Substudy E: Race Asian | — | 50 Participants | — | — | — | 50 Participants | — | — |
| Race/Ethnicity, Customized Substudy E: Race Black, African American, or African | — | 104 Participants | — | — | — | 104 Participants | — | — |
| Race/Ethnicity, Customized Substudy E: Race Middle Eastern or North African | — | 59 Participants | — | — | — | 59 Participants | — | — |
| Race/Ethnicity, Customized Substudy E: Race More than one race | — | 31 Participants | — | — | — | 31 Participants | — | — |
| Race/Ethnicity, Customized Substudy E: Race Native Hawaiian or Other Pacific Islander | — | 2 Participants | — | — | — | 2 Participants | — | — |
| Race/Ethnicity, Customized Substudy E: Race None of the above | — | 74 Participants | — | — | — | 74 Participants | — | — |
| Race/Ethnicity, Customized Substudy E: Race No response | — | 7 Participants | — | — | — | 7 Participants | — | — |
| Race/Ethnicity, Customized Substudy E: Race Prefer not to answer | — | 27 Participants | — | — | — | 27 Participants | — | — |
| Race/Ethnicity, Customized Substudy E: Race White | — | 847 Participants | — | — | — | 847 Participants | — | — |
| Race/Ethnicity, Customized Substudy F: Race American Indian or Alaska Native | — | 3 Participants | — | — | — | — | 3 Participants | — |
| Race/Ethnicity, Customized Substudy F: Race Asian | — | 44 Participants | — | — | — | — | 44 Participants | — |
| Race/Ethnicity, Customized Substudy F: Race Black, African American, or African | — | 177 Participants | — | — | — | — | 177 Participants | — |
| Race/Ethnicity, Customized Substudy F: Race Middle Eastern or North African | — | 24 Participants | — | — | — | — | 24 Participants | — |
| Race/Ethnicity, Customized Substudy F: Race More than one race | — | 17 Participants | — | — | — | — | 17 Participants | — |
| Race/Ethnicity, Customized Substudy F: Race Native Hawaiian or Other Pacific Islander | — | 2 Participants | — | — | — | — | 2 Participants | — |
| Race/Ethnicity, Customized Substudy F: Race None of the above | — | 45 Participants | — | — | — | — | 45 Participants | — |
| Race/Ethnicity, Customized Substudy F: Race No response | — | 4 Participants | — | — | — | — | 4 Participants | — |
| Race/Ethnicity, Customized Substudy F: Race Prefer not to answer | — | 16 Participants | — | — | — | — | 16 Participants | — |
| Race/Ethnicity, Customized Substudy F: Race White | — | 1121 Participants | — | — | — | — | 1121 Participants | — |
| Race/Ethnicity, Customized Substudy G: Race American Indian or Alaska Native | — | 12 Participants | — | — | — | — | — | 12 Participants |
| Race/Ethnicity, Customized Substudy G: Race Asian | — | 68 Participants | — | — | — | — | — | 68 Participants |
| Race/Ethnicity, Customized Substudy G: Race Black, African American, or African | — | 433 Participants | — | — | — | — | — | 433 Participants |
| Race/Ethnicity, Customized Substudy G: Race Middle Eastern or North African | — | 49 Participants | — | — | — | — | — | 49 Participants |
| Race/Ethnicity, Customized Substudy G: Race More than one race | — | 57 Participants | — | — | — | — | — | 57 Participants |
| Race/Ethnicity, Customized Substudy G: Race Native Hawaiian or Other Pacific Islander | — | 4 Participants | — | — | — | — | — | 4 Participants |
| Race/Ethnicity, Customized Substudy G: Race None of the above | — | 72 Participants | — | — | — | — | — | 72 Participants |
| Race/Ethnicity, Customized Substudy G: Race No response | — | 14 Participants | — | — | — | — | — | 14 Participants |
| Race/Ethnicity, Customized Substudy G: Race Prefer not to answer | — | 60 Participants | — | — | — | — | — | 60 Participants |
| Race/Ethnicity, Customized Substudy G: Race White | — | 2445 Participants | — | — | — | — | — | 2445 Participants |
| Sex/Gender, Customized Substudy A: Sex/Gender Female | 1049 Participants | 1049 Participants | — | — | — | — | — | — |
| Sex/Gender, Customized Substudy A: Sex/Gender Male | 749 Participants | 749 Participants | — | — | — | — | — | — |
| Sex/Gender, Customized Substudy A: Sex/Gender Prefer Not to Answer the Question | 1 Participants | 1 Participants | — | — | — | — | — | — |
| Sex/Gender, Customized Substudy A: Sex/Gender Undifferentiated | 0 Participants | 0 Participants | — | — | — | — | — | — |
| Sex/Gender, Customized Substudy A: Sex/Gender Unknown | 1 Participants | 1 Participants | — | — | — | — | — | — |
| Sex/Gender, Customized Substudy B: Sex/Gender Female | — | 755 Participants | 755 Participants | — | — | — | — | — |
| Sex/Gender, Customized Substudy B: Sex/Gender Male | — | 571 Participants | 571 Participants | — | — | — | — | — |
| Sex/Gender, Customized Substudy B: Sex/Gender Prefer Not to Answer the Question | — | 3 Participants | 3 Participants | — | — | — | — | — |
| Sex/Gender, Customized Substudy B: Sex/Gender Undifferentiated | — | 0 Participants | 0 Participants | — | — | — | — | — |
| Sex/Gender, Customized Substudy B: Sex/Gender Unknown | — | 2 Participants | 2 Participants | — | — | — | — | — |
| Sex/Gender, Customized Substudy C: Sex/Gender Female | — | 875 Participants | — | 875 Participants | — | — | — | — |
| Sex/Gender, Customized Substudy C: Sex/Gender Male | — | 528 Participants | — | 528 Participants | — | — | — | — |
| Sex/Gender, Customized Substudy C: Sex/Gender Prefer Not to Answer the Question | — | 1 Participants | — | 1 Participants | — | — | — | — |
| Sex/Gender, Customized Substudy C: Sex/Gender Undifferentiated | — | 1 Participants | — | 1 Participants | — | — | — | — |
| Sex/Gender, Customized Substudy C: Sex/Gender Unknown | — | 2 Participants | — | 2 Participants | — | — | — | — |
| Sex/Gender, Customized Substudy D: Sex/Gender Female | — | 871 Participants | — | — | 871 Participants | — | — | — |
| Sex/Gender, Customized Substudy D: Sex/Gender Male | — | 583 Participants | — | — | 583 Participants | — | — | — |
| Sex/Gender, Customized Substudy D: Sex/Gender Prefer Not to Answer the Question | — | 1 Participants | — | — | 1 Participants | — | — | — |
| Sex/Gender, Customized Substudy D: Sex/Gender Undifferentiated | — | 3 Participants | — | — | 3 Participants | — | — | — |
| Sex/Gender, Customized Substudy D: Sex/Gender Unknown | — | 1 Participants | — | — | 1 Participants | — | — | — |
| Sex/Gender, Customized Substudy E: Sex/Gender Female | — | 794 Participants | — | — | — | 794 Participants | — | — |
| Sex/Gender, Customized Substudy E: Sex/Gender Male | — | 414 Participants | — | — | — | 414 Participants | — | — |
| Sex/Gender, Customized Substudy E: Sex/Gender Prefer Not to Answer the Question | — | 0 Participants | — | — | — | 0 Participants | — | — |
| Sex/Gender, Customized Substudy E: Sex/Gender Undifferentiated | — | 0 Participants | — | — | — | 0 Participants | — | — |
| Sex/Gender, Customized Substudy E: Sex/Gender Unknown | — | 0 Participants | — | — | — | 0 Participants | — | — |
| Sex/Gender, Customized Substudy F: Sex/Gender Female | — | 872 Participants | — | — | — | — | 872 Participants | — |
| Sex/Gender, Customized Substudy F: Sex/Gender Male | — | 581 Participants | — | — | — | — | 581 Participants | — |
| Sex/Gender, Customized Substudy F: Sex/Gender Prefer Not to Answer the Question | — | 0 Participants | — | — | — | — | 0 Participants | — |
| Sex/Gender, Customized Substudy F: Sex/Gender Undifferentiated | — | 0 Participants | — | — | — | — | 0 Participants | — |
| Sex/Gender, Customized Substudy F: Sex/Gender Unknown | — | 0 Participants | — | — | — | — | 0 Participants | — |
| Sex/Gender, Customized Substudy G: Sex/Gender Female | — | 2021 Participants | — | — | — | — | — | 2021 Participants |
| Sex/Gender, Customized Substudy G: Sex/Gender Male | — | 1185 Participants | — | — | — | — | — | 1185 Participants |
| Sex/Gender, Customized Substudy G: Sex/Gender Prefer Not to Answer the Question | — | 3 Participants | — | — | — | — | — | 3 Participants |
| Sex/Gender, Customized Substudy G: Sex/Gender Undifferentiated | — | 2 Participants | — | — | — | — | — | 2 Participants |
| Sex/Gender, Customized Substudy G: Sex/Gender Unknown | — | 3 Participants | — | — | — | — | — | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,800 | 0 / 1,331 | 0 / 1,407 | 0 / 1,459 | 0 / 1,208 | 0 / 1,453 | 0 / 3,214 |
| other Total, other adverse events | 0 / 1,800 | 0 / 1,331 | 0 / 1,407 | 0 / 1,459 | 0 / 1,208 | 0 / 1,453 | 0 / 3,214 |
| serious Total, serious adverse events | 0 / 1,800 | 0 / 1,331 | 0 / 1,407 | 0 / 1,459 | 0 / 1,208 | 0 / 1,453 | 0 / 3,214 |
Outcome results
Primary
Total Number of Participants Randomized Within Each Appendix
Total number of participants randomized within each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT ID.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A - Ivermectin 400 | Total Number of Participants Randomized Within Each Appendix | 1800 Participants |
| Arm B - Fluvoxamine | Total Number of Participants Randomized Within Each Appendix | 1331 Participants |
| Arm C - Fluticasone | Total Number of Participants Randomized Within Each Appendix | 1407 Participants |
| Arm D - Ivermectin 600 | Total Number of Participants Randomized Within Each Appendix | 1459 Participants |
| Arm E - Fluvoxamine 100 | Total Number of Participants Randomized Within Each Appendix | 1208 Participants |
| Arm F - Montelukast | Total Number of Participants Randomized Within Each Appendix | 1453 Participants |
| Arm G - Metformin | Total Number of Participants Randomized Within Each Appendix | 3214 Participants |