On Apr. 9, 2020, BioCryst Pharmaceuticals announced the company has opened enrollment into a randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19.

Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well tolerated in previously reported Phase 1 trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS.

In the COVID-19 trial, efficacy measures include time to clinical improvement, time to hospital discharge, time to undetectable levels (as measured by polymerase chain reaction (PCR) in respiratory specimens) of SARS-CoV-2, the virus that causes COVID-19, and all-cause mortality.

The trial was conducted in Brazil under a U.S. investigational new drug application, and the protocol also has been approved by the Agência Nacional de Vigilância Sanitária (ANVISA) and the Brazilian National Ethics Committee (CONEP).

The trial (NCT03891420) was funded by the National Institute of Allergy and Infectious Diseases (NIAID).