Remdesivir Has ‘No Significant Effect’ on Ventilator COVID-19 Patients: Study

A lab technicians holds the COVID-19 treatment drug Remdesivir at Eva Pharma Facility in Cairo, Egypt, June 25, 2020. Amr Abdallah Dalsh/Reuters

Remdesivir has little effect on hospitalized COVID-19 patients who are on ventilators, according to results from a World Health Organization-backed (WHO) randomized trial and analysis.

The results, published in The Lancet (pdf), evaluated 14,221 patients from 454 hospitals in 35 countries, including 8,275 who were randomly assigned to receive up to 10 daily infusions of remdesivir or a control drug between March 2020 and January 2021—coming before the emergence of the Delta and Omicron COVID-19 variants.

About 602 patients of 4,146, or 14.5 percent, who were given remdesivir died. That’s compared with 643 deaths out of 4,129, or 15.6 percent, who were in the control group, according to the study’s authors.

Some 42.1 percent of patients, or 151 out of 359, who were already on a ventilator and were given remdesivir died, the study found. That’s compared with 134 deaths among 347 ventilator patients, or 38.6 percent, who were in the control group, researchers said.

“Remdesivir has no significant effect on patients with COVID-19 who are already being ventilated. Among other hospitalized patients, it has a small effect against death or progression to ventilation (or both),” the researchers concluded in an abstract of the study.

Researchers found in their trial and analysis that the drug may give a slight benefit to COVID-19 patients who are receiving oxygen but are not on a ventilator. Of the patients who were only receiving oxygen, 14.6 percent of those who received remdesivir died, while 16.3 percent of those in the control group died.

“However, given that high-flow and low-flow oxygen were not recorded separately at enrollment into Solidarity, it is not known whether any protective effect in non-ventilated patients extends to those on high-flow oxygen,” they noted.

Following their analysis, the researchers said that better COVID-19 treatments and drugs are needed.

“Regardless of how these findings are interpreted, better drugs to treat COVID-19 will continue to be needed. Oral antiviral agents, various immune modulators, and monoclonal antibodies against currently circulating variants of concern are now emerging that might prove more effective, more convenient, or less expensive than daily remdesivir infusions, but large-scale randomized evidence will be needed to evaluate and compare them,” they wrote.

But Dr. Carolina Garcia-Vida, of University of Barcelona in Spain, and Dr. Maurizio Sanguinetti of the Fondazione Policlinico Universitario A Gemelli in Rome, wrote in a Lancet-published commentary on the study that the trial has some limitations.

“A clear limitation of the trial is not including data on days since symptom onset to remdesivir use, viral load as measured by cycle threshold values, or viral antigen levels (or even viraemia). These factors might prove more suitably integral in evaluating the effectiveness of remdesivir,” they jointly said. Viremia is when viruses enter the bloodstream and then have access to the rest of the body.

Earlier this year, a study found that a combination of remdesivir and a concentrated solution of antibodies did not perform well in people hospitalized with the virus.

Researchers stated that “there was no evidence that patients who received a single infusion of hIVIG in addition to remdesivir and other standard of care had better clinical outcomes at day 7 after randomization than patients who received placebo plus remdesivir and standard of care.”

Nonetheless, the U.S. Food and Drug Administration on April 25 expanded approval of Veklury, or remdesivir, to include pediatric patients who are 28 days and older, weigh at least 7 pounds, and have tested positive for COVID-19.

Possible remdesivir side effects include increased liver enzyme levels, which may be a sign of hepatotoxicity, or liver injury, as well as various allergic reactions such as blood pressure changes, low blood oxygen levels, shortness of breath, fever, swelling, sweating, shivering, or nausea.