What Is Remidesivir ? How It Is Contributed In Treatment Of Covid-19 ?

Remdesivir is an antiviral that is given by intravenous (IV) infusion in the hospital. This is a brand-new drug that has not been approved by the FDA for use on the market yet, and is being tested in carefully controlled environments. It was previously shown to have some effect against SARS, MERS, and Ebola in cell and animal models. In a recent in vitro study (studies done in a petri dish or test tube rather than in animals or humans), remdesivir prevented human cells from being infected with SARS-CoV-2 (the virus that causes COVID-19).

Doctors across the U.S. are enrolling patients with severe COVID-19 into clinical trials to see if remdesivir is an effective treatment. Gilead recently announced early results from a Phase 3 trial. According to the manufacturer, half of the patients who got remdesivir saw improvements in about 10 days (regardless of whether they were treated for 5 or 10 days) and more than half were discharged from the hospital by week 2.

Early results from a large U.S. study of 1,063 patients showed that people who got remdesivir recovered faster compared to those who got a placebo (11 days vs. 15 days, respectively). The death rate in the remdesivir group (8%) was also lower than the placebo group (11%). More details from this study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), are expected to be shared soon.

Based on the positive reports from these two studies, the FDA issued an emergency use authorization (EUA) for remdesivir on May 1, 2020. The EUA does not mean that the FDA has approved remdesivir for the treatment of COVID-19. Rather, the intent of the EUA is to make it easier for doctors to get remdesivir for hospitalized patients with severe COVID-19 symptoms. These are patients who require mechanical ventilation or extra oxygen. More information about the remdesivir EUA can be found here.

In addition to the study above, a small study of 61 patients who were severely ill with COVID-19 and received remdesivir through a compassionate use program was published earlier in April 2020. (Compassionate use is a way for people to receive experimental drugs without being in a clinical trial.) Data for 8 patients was unavailable, but for the remaining 53 patients, 36 (68%) needed less oxygen support after treatment, and 7 (13%) died.

Because this was through a compassionate use program, limited data was collected. For example, information about viral load (the amount of virus in the body) was not available, so we do not know if remdesivir was effective in clearing the virus. Additionally, there was not a comparison group, so it is difficult to know whether patients would have improved on their own without taking remdesivir.

Not all remdesivir studies have been positive. Take a study of 236 patients with COVID-19 in China, for example. (This was a randomized, double-blinded study, which is the gold standard for clinical trials.) In one specific analysis, a group of patients in the study who received remdesivir within 10 days of showing symptoms recovered slightly more quickly than those who received a placebo. However, this difference was not statistically significant, meaning it could have been due to chance. When looking at all patients in the study (regardless of when they received remdesivir), there was no difference in time to improvement compared to placebo. The researchers state that larger studies are needed to confirm the results.