Collaboration Details

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Title of Collaborative Activity:

Accelerating COVID-19 Therapeutic Interventions and Vaccines-6: Outpatient Repurposed Drugs (ACTIV-6)

Description of Collaborative Activity:

The ACTIV public-private partnership has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates. ACTIV-6 is designed to test the effectiveness of repurposed drugs (drugs that are FDA-approved for non-COVID-19 indications and have known safety profiles) in reducing the duration and severity of symptoms associated with mild-to-moderate COVID-19. The large, randomized, placebo-controlled Phase 3 trial is enrolling outpatient participants who are at least 30 years old, have tested positive for SARS-CoV-2 infection and show two or more mild-to-moderate symptoms of COVID-19 for no more than seven days. Results for ivermectin, fluvoxamine and fluticasone are available on medRxiv. Results for ivermectin and fluvoxamine have been published in JAMA. Testing of montelukast is ongoing.

Type of Collaborative Activity:

Research Initiative

Year the Collaborative Activity Originated:

2021

NIH Participating Institutes/Centers/Office of the Director:

NIAID, NHLBI, NCATS

HHS Agency Collaborators on this Activity:

CDC, FDA, ASPR