Salt Lake City, UT -- (ReleaseWire) -- 01/03/2022 --Intermountain Healthcare researchers played a key role in a new international study that has found that an antiviral drug designed to inhibit the ability of the SARS-CoV-2 virus to reproduce itself is effective at preventing severe illness from COVID-19 when given early in the symptom course.
Results from the new study of the effectiveness of the drug, Remdesivir, in treating COVID patients, which is published recently in the New England Journal of Medicine, are encouraging, according to Brandon Webb, MD, an infectious diseases physician at Intermountain Healthcare and local principal investigator of the study.
"These results highlight the importance of early antiviral treatment of the 'viral phase' of illness," said Dr. Webb. "They suggest that Remdesivir is another useful option for treating patients who are at higher risk of having more severe disease or needing hospitalization. This is especially important because omicron has disrupted the landscape for treatments. Several of our monoclonal antibodies are no longer effective against omicron. Now more than ever, we need as many effective tools as possible for treating COVID-19."
Remdesivir is an antiviral drug that inhibits the ability of the SARS-CoV-2 virus to multiply. It is FDA-approved for treatment of moderate and severe COVID-19 in hospitalized patients, based on data that suggested that it helps patients recover more quickly. Remdesivir is expected to be fully active against all known variants, including omicron.
All anti-viral medications work best very early in the course of infection when the viral levels are highest, according to Dr. Webb.
The PINETREE trial aimed to find out whether Remdesivir is effective at preventing severe illness when given intravenously, once a day for three days to non-hospitalized patients.
Patients were eligible to participate if they were at least moderate to high risk for hospitalization and still within the first seven days after symptoms began. It was a phase III, placebo-controlled randomized trial that enrolled patients in more than 30 sites in the United States and Europe.
Intermountain Healthcare was one of the top participating sites in the United States, and Intermountain investigators helped to design the trial.
"Intermountain and the community it serves have repeatedly demonstrated their ability to solve hard problems quickly, even in the face of the terrible hardships created by this awful virus," said Samuel Brown, MD, senior medical director for clinical trials at Intermountain Healthcare and a member of the PINETREE trial steering committee. "The PINETREE trial—identifying another solid treatment to prevent severe disease and lessen the burden on hospitals—is a key reminder of that fact. I'm incredibly proud to be part of the Intermountain community."
Intermountain used a novel research model by partnering with Intermountain Homecare and Hospice so that trial participants could be treated by experienced research nurses in their own homes.
The trial originally planned to enroll about 1,200 patients, but by late spring, the availability of monoclonal antibodies and vaccines made it difficult to find eligible patients, so the trial was stopped and analyzed with more than 600 participating patients.
Results from the PINETREE trial showed that when given early in the symptom course to moderate and high-risk patients, Remdesivir reduced the risk of requiring hospitalization by 87%.
Researchers say there are some important limitations to this treatment making an immediate impact.
- First, identifying higher risk patients early in the symptom course remains a challenge. It is important that patients who are older, overweight, or who have chronic medical conditions or problems with their immune system get tested as soon as possible after developing even mild symptoms like runny nose, cough, sore throat, fevers, chills, body aches, or loss of taste or smell.
- Second, Remdesivir is currently only available intravenously, which limits where patients who are contagious with COVID-19 can get treated.
- And third, because these results are brand new, insurance companies may not yet cover Remdesivir given outside of the hospital.
The FDA is currently considering whether these new data merit formal authorization of the drug's use in non-hospitalized patients.
"While we remain committed to fostering the discovery of and are grateful for all effective treatment options for COVID-19, it is important to remember that preventive measures and vaccination remain by far the most effective and most economical methods for preventing hospitalization and saving lives," said Dr. Webb.
About Intermountain Healthcare
Located in Utah, Idaho, and Nevada, Intermountain Healthcare is a nonprofit system of 25 hospitals, 225 clinics, the Intermountain Medical Group with some 2,700 employed physicians and advanced care practitioners, a health plans division called SelectHealth, Homecare, and other health services. Helping people live the healthiest lives possible, Intermountain is committed to improving community health and is widely recognized as a leader in transforming healthcare by using evidence-based best practices to consistently deliver high-quality outcomes at sustainable costs. For updates, see https://intermountainhealthcare.org/news.