BioCryst Pharmaceuticals, Inc. announced last week that 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 will be 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).
“Galidesivir has been safe and well-tolerated in Phase 1 studies, and, as a potent broad-spectrum antiviral medicine, we are hopeful that we will see a benefit in patients with COVID-19. This trial is part of the scientific community’s effort to urgently find effective treatments for patients in this global health emergency,” said Dr. William Sheridan, chief medical officer of BioCryst.
“We have begun to see COVID-19 cases in Brazil, and we have a good opportunity to enroll and treat patients earlier in their disease course to determine if galidesivir can benefit patients with COVID-19,” said Dr. Esper Kallas, infectious diseases specialist and professor of medicine at the School of Medicine, University of São Paulo, and principal investigator of the COVID-19 clinical trial with galidesivir.
The trial (NCT03891420) is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
- Washington COVID-19 case count, DOD field hospital being returned
- Ecuador COVID-19 cases top 7,000, More than 600 health professionals join the fight
- Communities and COVID-19: Perspectives from a health promotion expert
- Brazil COVID-19 deaths top 1000, One million tests distributed
- FDA warning: Ivermectin meant for animals are not for human treatment for COVID-19
- Ebola case reported in DRC, 2 days before calling end to epidemic