Global Clinical Trial of Therapeutics for Severely-Ill Hospitalized COVID-19 Patients Begins at Intermountain
Intermountain Researchers at Forefront of New NIH Multi-Center Study.
Salt Lake City, UT -- (ReleaseWire) -- 04/29/2021 --Researchers at Intermountain Healthcare are at the forefront of a new, multi-center National Institutes of Health study that is being launched across the nation to test the safety and efficacy of therapeutics for COVID-19 patients with life-threatening cases of the virus, including those with acute respiratory failure.
Samuel Brown, MD, MS, critical care physician and researcher at Intermountain Healthcare in Salt Lake City, is the principal investigator of the Phase 3 trial called ACTIV-3 Critical Care.
Dr. Brown is coordinating with scientists at study sites throughout the world, including the Data Coordinating Center at University of Minnesota, the PETAL Network based at Massachusetts General Hospital, the CTSN Network based at Mt Sinai, the INSIGHT Washington DC Network, and others.
The trial will test two therapeutic agents – Zyesami and Veklury/remdesivir – both alone and in combination with a placebo to determine their safety and efficacy in hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS), a life-threatening condition in which the lungs are severely inflamed and may be unable to maintain sufficient oxygen in the blood.
The randomized, blinded, placebo-controlled clinical trial is part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to prioritize and accelerate development of the most promising COVID-19 treatments.
This is the first ACTIV trial that focuses entirely on patients with COVID ARDS, the most severe phase of COVID illness, according to Dr. Brown, medical director of critical care and pulmonary research at Intermountain.
"As clinicians, we're in great need of treatments for this group of patients. The hope is that one of the two drugs will be effective in helping these patients, but that's what needs to be determined through these trials," said Dr. Brown.
Intermountain is a pioneer in the treatment of ARDS and has been involved in numerous studies and research on best practices for more than 40 years.
"There is a strong body of previous research that supports the use of these agents in ARDS, which is associated with substantial morbidity and mortality," said Gary H. Gibbons, MD, director of the National Heart, Lung, and Blood Institute. "Not only is this an important trial, in terms of potential new treatments for COVID-19, but it could open new understanding into the repair of damaged lungs following ARDS."
Zyesami is a formulation of aviptadil acetate, a synthetic version of the hormone the body makes that helps protect lung cells and decrease reproduction of the COVID virus, while remdesivir is an antivirus drug that appears to work in treating patients with milder COVID disease but is unproven as a treatment option in patients with more severe COVID disease.
"Finding more effective therapeutics for critically-ill COVID-19 patients remains an essential need in the ongoing response to the pandemic," said NIAID Director Anthony S. Fauci, MD. "We need more treatment options to increase the chances of recovery for people who are extremely sick so they can leave the hospital more quickly, continue their recovery at home, and return to life as usual."
The ACTIV-3 Critical Care trial allows for sub-studies of different therapeutics to run concurrently. Each sub-study will enroll approximately 620 participants at 50 study sites in the United States.
Trial participants will be randomly assigned to receive either the investigational agents in the sub-study or a placebo. In the current version of the study, participants will be randomly assigned to receive one of four treatment regimens in addition to standard of care: both Zyesami and remdesivir, Zyesami and a placebo, remdesivir and placebo, or only placebo.
Zyesami will be administered for 12 hours daily for three days, with the infusion rate increasing each day. Those randomized to receive remdesivir will receive it for up to 10 days via IV.
Researchers will enroll hospitalized patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen, delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation.
Initially, a small cohort of 40 participants will be enrolled at study sites throughout the nation. If no safety concerns are identified, a larger group of participants will be enrolled at additional U.S. and international sites. If necessary, the treatment regimens may be adjusted before additional participants are enrolled.
For the primary analysis of the trial, participants will be assessed on a six-category ordinal scale 90 days after enrollment, and outcomes will be compared among treatment groups. This scale ranges from recovered and living at home without supplemental oxygen within two weeks of enrollment, to death.
Following the assessment at the primary endpoint, participants will receive one additional follow-up at 180 days.
Other leaders of the participating networks include James Neaton, PhD, of the NIAID-sponsored International Network for Strategic Initiatives in Global HIV Trials network; Taylor Thompson, MD, of the Prevention and Early Treatment of Acute Lung Injury network; Annetine Gelijns, PhD, and Alan Moskowitz, MD, of the Cardiothoracic Trials Surgical Network, both NHLBI-sponsored networks; and Victoria Davey, PhD, MPH, of the US Department of Veterans Affairs
About Intermountain Healthcare
Intermountain Healthcare is a nonprofit system of 25 hospitals, 225 clinics, a Medical Group with 2,600 employed physicians and advanced practice clinicians, a health insurance company called SelectHealth, and other health services in Utah, Idaho, and Nevada. Over the years, Intermountain researchers have been involved in many thousands of studies across dozens of clinical specialties. Currently, over 1,600 studies are open and actively underway within the Intermountain system. Intermountain is widely recognized as a leader in transforming healthcare by using evidence-based best practices to consistently deliver high-quality outcomes and sustainable costs.
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