Stanford professor Aruna Subramanian probing if it reduces symptoms and viral shedding in outpatients.
US researchers including Aruna Subramanian, an Indian American professor, are launching a clinical trial to test whether an oral drug can reduce covid-19 symptoms and viral shedding or release of the virus into the environment,
The researchers at Stanford Medicine aim to enroll 120 participants, beginning July 6, who have been recently diagnosed with the disease but not been hospitalized, according to a media release.
Researchers want to determine whether favipiravir, an oral drug first approved to treat influenza in Japan, is effective in reducing the severity of symptoms and shortening the duration of covid-19.
The double-blind, placebo-controlled trial is intended to see if it will be effective in reducing the severity of symptoms and in shortening the duration of covid-19, which could help limit spread of the coronavirus, said Aruna Subramanian, MD, clinical professor of medicine.
“We hope that this drug can help to reduce transmission within families, groups and schools,” she said. “Plus, it would be really nice to have pills that can be given early on to make people get better faster.”
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 US, Subramanian said. It has been approved to treat covid-19 in Russia, China and India.
Stanford participated in earlier clinical trials that found that another antiviral, remdesivir, was effective in treating coronavirus patients.
That drug has since been approved for use in the US but is not available orally and, so far, can be administered only intravenously and only to those in a hospital.
“Favipiravir could be very important for symptom relief, especially for patients with mild cases who can have symptoms for a long time,” Subramanian said.
“We’ve seen a number of symptoms continue, such as coughs, shortness of breath, fatigue.” 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 treatcovid@stanford.
“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.
Covid-19: Indian American led study indicates efficacy of new drug (April 30, 2020)