Three Massachusetts hospitals have received approval to launch the first US clinical trial of a Japanese flu drug that could be used to treat COVID-19, according to a doctor involved in the effort.
The trial — which will take place at Massachusetts General Hospital, Brigham and Women’s Hospital, and UMass Memorial Medical Center in Worcester — was approved by the federal Food and Drug Administration Tuesday. The small, randomized trial of the antiviral drug favipiravir will look to study its effectiveness as a treatment for patients infected with the coronavirus, according to doctors involved in the study.
The Japanese government has touted the drug, known by the brand name Avigan, as a possible treatment for COVID-19 Medical authorities in China have called the drug
“clearly effective” in treating coronavirus patients after conducting two clinical trials.
The drug was produced by a pharmaceutical subsidiary of Japan-based Fujifilm more than a decade ago as a treatment for new and reemerging strains of influenza. The company has not yet confirmed the details of the US trial.
Some
virologists and regulators have raised concerns about using it as a coronavirus treatment without further testing, though the Trump administration is reportedly pushing the FDA to approve it as
an emergency treatment for the virus, according to Politico.
Doctors involved in the planned Massachusetts trial note that the drug has been used widely in humans, so the side effects are relatively well known. The potential benefits for a COVID-19 patient ill enough to be admitted to the hospital far outweigh the potential risks of side effects, the doctors said.
The drug works by causing the virus to misread its genetic instructions and not reproduce correctly, “so that the virus eventually melts down in the test tube,” Finberg said, describing his previous research on it. Researchers believe it will work the same way with the coronavirus, he said.
“It’s actually a very safe drug," Finberg said.
Chinese researchers carried out two clinical trials of favipiravir,
reporting positive results, though Fujifilm Toyoma Chemical, the drug’s developer, has declined to comment on the Chinese claims. Some of the
data out of China showed that patients who were given the medicine were virus-free more quickly than those who did not receive the drug, and X-rays showed lung improvement among more of those who took the drug, according to news reports.