ACTIV-6: COVID-19 Study of Repurposed Medications - Arm A (Ivermectin 400)

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. This protocol was originally registered under NCT04885530. Per recent guidance on reporting master protocol research programs (MPRPs), a separate record for Arm A was created.

Conditions

• Covid19

Interventions

DRUG

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.

OTHER

Placebo

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.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Vanderbilt University Medical Center

  collaborator OTHER

• Susanna Naggie, MD

  lead OTHER

Principal Investigators

• Susanna Naggie, MD · Duke Clinical Research Institute

• Adrian Hernandez, MD · Duke Clinical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-08

Primary Completion

2022-03-15

Completion

2022-05-16

FDA Drug

Yes

Countries

• United States

Study Locations