Gilead Sciences, a California biotech company says its experimental drug remdesivir improved symptoms when given for five days to moderately ill, hospitalized patients with COVID-19.
The company released some information about a study they conducted, on Monday but said full results would soon be published in a medical journal.
The drug is given through an IV and is designed to interfere with an enzyme the virus uses to copy its genetic material.
The company-led study involved nearly 600 patients who had moderate pneumonia but did not need oxygen support. All were randomly assigned to get five or 10 days of the drug plus standard care, or standard care alone. Patients and their doctors knew who was getting what, which limits the objectivity of the results.
By the 11th day in the study, patients who were treated with five days of remdesivir were 65 percent more likely to improve by at least one on a seven-point scale that included measures such as needing treatment with a breathing machine, Gilead said. Ten days of treatment did not prove better than standard care alone.
There were no deaths among patients on five days of the drug, two among those on 10 days, and four among patients getting standard care alone. Nausea and headache were a little more common among those on the drug.
The study has some limitations, but "there was a control group which does help verify that remdesivir has some benefits," said Dr Radha Rajasingham, an infectious disease specialist at the University of Minnesota Medical Center in Minneapolis who had no role in the work.
Since there are limited supplies of the experimental drug, finding benefit from five versus 10 days means more people can be treated, she added.
In a note to investors, Evercore ISI analyst Umer Raffat noted that the study's main goal was changed partway through, from the percentage of patients discharged within two weeks to the scale of improvement after 11 days.
"A fair amount of critical data," such as hospital discharge information, has not been disclosed, he wrote.
Remdesivir is the only treatment that's been shown in a rigorous experiment to help fight the coronavirus. A large study led by the National Institutes of Health recently found it could shorten average recovery time from 15 days to 11 days in hospitalized patients with severe disease.
It is approved for treating COVID-19 in Japan and is authorized for emergency use in the United States for certain patients.
Dr V G Somani, the Drugs Controller General of the Central Drugs Standard Control Organisation has approved the administration of remdesivir to patients in a "restricted emergency use". Only adults and children who are suspected or have laboratory-confirmed cases and show signs of a sever COVID-19 infection will be given this drug for a period of five days. The CDSCO also said that this drug will be given in "hospital setting" only.
"As per the data presented by the company so far, administering remdesivir for 10 days as opposed to five doesn't have any beneficial effects, so why should patients consume it for an additional five days? There is also a potential risk of the mortality rate increasing with extended use, so the authority has been more stringent with its decisions compared to other countries," a senior Health Ministry official close to the development said on condition of anonymity told The Indian Express.
"The drug, which is administered in the form of an injection, has been approved to be sold by retail on the prescription of specialists for use in hospital or institutional setup only," another source told PTI. "The approval process for remdesivir was accelerated by invoking special provisions under the New Drug and Clinical Trial Rules, 2019, which provides for waiver of clinical trials in special circumstances."
"The drug is given in the form of an injection and that is why it has to be administered under the supervision of a doctor in a hospital setting," the source added.
With input from agencies