NCT04885530

ACTIV-6: COVID-19 Study of Repurposed Medications

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

ACTIVE_NOT_RECRUITING

NCT ID:

NCT04885530

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

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.

Eligibility

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

Disease(s) and\or Condition(s)

Covid19

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Ivermectin
- Description: 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 Group Labels: Arm A - Ivermectin 400, Arm D - Ivermectin 600
- Type: DRUG
- Name: Fluvoxamine
- Description: 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 Group Labels: Arm B - Fluvoxamine, Arm E - Fluvoxamine 100
- Type: DRUG
- Name: Fluticasone
- Description: 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 Group Labels: Arm C - Fluticasone
- Type: OTHER
- Name: Placebo
- Description: 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.
- Arm Group Labels: Arm A - Placebo, Arm B- Placebo, Arm C - Placebo, Arm D - Placebo, Arm E - Placebo, Arm F - Placebo, Arm G - Placebo
- Type: DRUG
- Name: Montelukast
- Description: 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 Group Labels: Arm F - Montelukast
- Type: DRUG
- Name: Metformin
- Description: 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.
- Arm Group Labels: Arm G - Metformin

Sponsor

Susanna Naggie, MD