“We hope that this drug can help to reduce transmission within families, groups and schools,” said Subramanian, one of the investigators for the study. “Plus, it would be really nice to have pills that can be given early on to make people get better faster.”
Yvonne Maldonado, MD, professor of pediatrics and of health research and policy, is the principal investigator for the double-blind, placebo-controlled trial.
The drug has not been approved by the Food and Drug Administration. There are other trials investigating the drug, but this is the first time it will be tested in outpatients in the U.S., Subramanian said. It has been approved to treat COVID-19 in Russia, China and India.
“Many really important studies are going on right now to help us understand how to emerge from this pandemic,” said Marisa Holubar, MD, clinical associate professor of infectious disease and an investigator for the study. “These early-phase studies are important to inform larger clinical trials. We need to understand if favipiravir shortens the duration of viral shedding. It could be a key to protecting both ourselves and the broader community.”
At a molecular level, the drug works by blocking a viral enzyme that makes viral RNA, halting the virus’s ability to replicate itself, Holubar said. Like other antivirals, it’s presumed to work better the earlier it’s prescribed.
Researchers are enrolling those who have been diagnosed with COVID-19 within the past 72 hours. Each participant will receive either a 10-day course of favipiravir or a placebo, and they will be evaluated for health outcomes over 28 days.
People can enroll by emailing email@example.com.