By Deena Beasley
(Reuters) – More than two-thirds of critically ill COVID-19 patients have improved after treatment with remdesivir, an investigational drug developed by Gilead Sciences Inc., according to new data based on observation of patients.
The analysis, published Friday by the New England Journal of Medicine, does not detail what other treatments the 61 hospitalized patients were administered and data on eight of them were not included – in one case due to a dosage error.
The article author described the results as “hope,” but cautioned that it is difficult to interpret the results because they do not include comparison with a control group, as would be the case in a randomized clinical trial. In addition, the number of patients was small, the details disclosed were limited and the follow-up time was relatively short.
There is currently no approved preventive treatment or vaccine for COVID-19, the respiratory disease caused by the new coronavirus that has killed more than 100,000 people worldwide.
Last month, Gilead severely curtailed its compassionate use program for remdesivir and is conducting its own clinical trials of the antiviral drug, with results expected in the coming weeks. Researchers in China and the National Institutes of Health in the United States are also testing the drug in COVID-19 patients.
The new analysis includes patients in the United States, Europe, Canada, and Japan who received a 10-day course of intravenous remdesivir.
Before treatment, 30 patients were on mechanical ventilators and four were on a machine that pumps blood from the patient’s body through an artificial oxygenator. After a median follow-up of 18 days, 36 patients, or 68%, experienced an improvement in the oxygen support class, including more than half of the 30 patients receiving mechanical ventilation with the respiratory tubes removed. A total of 25 patients, or 47%, were discharged from the hospital. Seven patients, 13% of the total, died.
Twelve patients, 23%, experienced serious side effects, including multiple organ dysfunction syndrome, septic shock and acute renal failure.
“We are eagerly awaiting the results of controlled clinical trials to potentially validate these results,” wrote Dr. Jonathan Grein, journal chief author and director of hospital epidemiology at Cedars-Sinai Medical Center in Los Angeles.
(Report by Deena Beasley; editing by Daniel Wallis)