University of Nebraska Medical Center infectious disease physician Andre Kalil, MD, is author of a paper that shows that remdesivir and baricitinib together have benefits in treating hospitalized patients with COVID-19 pneumonia.
The paper is published online in the Dec. 11 New England Journal of Medicine, which is among the most prestigious, peer-reviewed journals. It provides scientific findings of the Adaptive COVID-19 Treatment Trial (ACTT-2), a clinical trial to evaluate therapeutics in patients hospitalized with COVID-19 who need supplemental oxygen or more advanced respiratory support to treat the pneumonia. Initial results of the study were released in September.
The clinical trial was conducted in 67 hospitals in eight different countries with 1,033 volunteer study participants, including at UNMC, which was among the sites with the largest number of participants, said Dr. Kalil, who is first author of the paper and one of the principal investigators of the trial.
The study was supported in part by grants from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and the National Cancer Institute. The clinical trial is the second iteration of the Adaptive COVID-19 Treatment Trial.
Researchers tested the combination of the two drugs to see if reducing the viral burden and improving the inflammatory response at the same time could produce more benefits than reducing the viral burden alone. Dr. Kalil said the virus that causes COVID-19 provokes an inflammatory imbalance that causes more lung problems, further aggravating breathing problems.
"We found that the baricitinib plus remdesivir sped up the clinical improvement, shortened the time in the hospital, and reduced the progression to mechanical ventilation or death in hospitalized patients with COVID-19 pneumonia," Dr. Kalil said about the study launched in May. "These results were all significant and clinically meaningful to our patients."
He said the study shows for the first time in medical history that the combination of an agent that acts in the immune system with an anti-viral medication together shows clinical benefits in acute viral pneumonia.
"Our novelty findings will certainly pave the way for the discovery of new treatments for other life-threatening infectious diseases," he said.
Dr. Kalil said another fourth stage of the ACCT trial, called ACTT-4, began in November and is comparing two different combination therapies in hospitalized patients with COVID-19 — baricitinib plus remdesivir, versus dexamethasone plus remdesivir.
"This will be an important trial to define which combination will bring the most benefits to patients with moderate to severe COVID-19 pneumonia," Dr. Kalil said, who has been involved in all the trials.
Dexamethasone is a corticosteroid used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects. Remdesivir is an antiviral medication developed by Gilead Sciences, Inc., which the FDA approved as a treatment for hospitalized patients with COVID-19 pneumonia. Baricitinib was discovered by Incyte, licensed to Eli Lilly and Company and marketed under the brand name Olumiant. It is FDA-approved as a treatment for adults with moderately-to-severely active rheumatoid arthritis.
In May this year, researchers published preliminary results of the Adaptive COVID-19 Treatment Trial (ACTT) that compared the investigational antiviral remdesivir to the standard of care for the treatment of COVID-19. Remdesivir was found to be superior compared to standard of care.
The Dec. 11 article can be found at: https://www.nejm.org/doi/full/10.1056/NEJMoa2031994?query=featured_home. The NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.
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