NIH to fund large re-purposed drug study

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Large NIH-funded study to explore repurposed drugs for mild-to-moderate COVID-19

Apr. 19, 2021 12:58 PM ETGilead Sciences, Inc. (GILD)By: Dulan Lokuwithana, SA News Editor4 Comments


The National Institutes of Health (“NIH”) has allocated $155M for a large Phase 3 study that will evaluate several existing prescription and over-the-counter medications for self-administration in people with mild-to-moderate COVID-19.


Targeting the patients who are not sick enough for hospitalization, the study will begin the enrollment process in a few weeks, NIH said in a press release.


The randomized, placebo‑controlled trial named ACTIV-6 will involve ~13.5K participants aged 30 years and more having COVID-19 with two or more mild-to-moderate symptoms for up to seven days.


“We don’t currently have an approved medication that can be self-administered to ease symptoms of people suffering from mild disease at home, and reduce the chance of their needing hospitalization,” said NIH Director Francis S. Collins.


“ACTIV-6 will evaluate whether certain drugs showing promise in small trials can pass the rigor of a larger trial.”


Currently, the antiviral drug Remdesivir from Gilead (GILD -1.1%) is approved by the FDA for hospitalized patients with COVID-19.


And for the treatment of outpatients with mild to moderate COVID-19, the FDA has also granted the emergency use authorization for Bamlanivimab developed by Eli Lilly (LLY +0.5%) and the antibody cocktail of Casirivimab plus Imdevimab from Regeneron (REGN -0.4%).


Both treatments are administered intravenously. Recently, Merck (NYSE:MRK) narrowed down its focus on oral antiviral MK-4482 (molnupiravir) to study only the outpatients with COVID-19 in a Phase 3 trial.