Remdesivir, an experimental drug, is being tested on patients to determine its efficacy against the COVID-19 in people suffering from mild to severe respiratory distress. The drug, developed by Gilead Sciences, shortens the recovery period of patients suffering from the disease.
In the study, patients receiving a 10-day treatment course of remdesivir showed the same results as a 5-day treatment course. Gilead is doing two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir in countries with a high prevalence of COVID-19 infection. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive remdesivir. Recently, the study was expanded to enroll an additional 5,600 patients, including patients on mechanical ventilation.
“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, Ph.D., Chief Medical Officer, Gilead Sciences.
“These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”
Study finds remdesivir effective
Remdesivir has not been approved anywhere as a line of treatment for Covid-19. The study wanted to establish if short duration administration of the drug was as effective as a long durations one. The other objective of the study is to observe any adversarial impact of the treatment and to record additional responses of the patients.
Patients treated with the medicine had only mild symptoms of pneumonia and oxygen levels that did not require mechanical ventilation at the time of the study. Clinical improvement was defined as an improvement of two or more points from baseline on a predefined seven-point scale, ranging from hospital discharge to increasing levels of oxygen support to death. Patients were discharged if they no longer required oxygen support and medical care.
In this study, the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14. The trials are being conducted at 180 sites around the world, including in the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom.
Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at Day 14 was 7 percent across both treatment groups, with 64 percent of patients experiencing clinical improvement at Day 14 and 61 percent of patients discharged from the hospital.
It was noted that patients who received treatment within 10 days of onset of symptoms had better chances of recovery than those who were treated after. Sixty-two percent of patients who were treated early were discharged from hospital compared to 49 percent who were treated later than 10 days of infection.
“These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the lead investigators of the study. “While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.”
No major side effects noticed
No major side effects of remdesivir were noticed. Nausea was seen in 10 percent of the patients in both groups. Seven percent of patients had some high level of liver enzyme and 3 percent discontinued the medicine due to elevated liver tests.
A second SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in patients with moderate manifestations of COVID-19, compared with standard of care. The results from the first 600 patients of this study are expected at the end of May.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that develops and commercializes innovative medicines. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. It should be noted that remdesivir is an investigational agent that has not been licensed or approved anywhere globally. There are chances of unfavorable results from ongoing trials and the possibility that the timeline of the trials may be extended. The trial drug may not get approved by the FDA or other such agencies for commercialization. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
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