For more than two years, scientists have been working around the clock to find ways to prevent severe illness and deaths from COVID-19.
A recent international study co-led by University of Nebraska Medical Center Physician/Scientist Andre Kalil, MD, MPH, compared the effectiveness of two different drugs being used to treat COVID. Results of the study were recently published in the Lancet journal.
The study compared the combination of baricitinib plus remdesivir versus dexamethasone plus remdesivir in preventing progression to mechanical ventilation or death in hospitalized patients with COVID-19.
The treatments baricitinib and dexamethasone have been studied in separate studies and support the treatment of patients with COVID-19. However, they have not been compared to each other in the same study.
In this new randomized, double-blind, double placebo-controlled trial, patients were enrolled at 67 trial sites (60 in the U.S.) with COVID-19 who required supplemental oxygen, high-flow, or non-invasive ventilation.
Dr. Kalil said in hospitalized patients with COVID-19 requiring supplemental oxygen, high-flow, or non-invasive ventilation, baricitinib plus remdesivir and dexamethasone plus remdesivir resulted in similar mechanical ventilation-free survival by day 29.
"But dexamethasone was associated with significantly more adverse events, treatment-related adverse events, and severe or life-threatening adverse events," he said. "A more individually tailored choice of immunomodulation now appears possible, where side-effect profile, ease of administration, cost, and patient comorbidities can all be considered."
Dr. Kalil said the study was important because it was the first study during the pandemic that compared head-to-head two different drugs (dexamethasone versus baricitinib) that act by modulating the immune system, also called immunomodulatory therapies.
He and his colleagues have seen the worst of what COVID does to people. Considering current rising hospitalization and infection rates, his advice for the public?
"Completing the vaccination schedule remains essential to prevent to worst consequences of COVID-19, that is, hospitalization and death," Dr. Kalil said. "COVID-19 infections without the need for hospitalization and long COVID are also decreased by vaccination, but they can still occur, thus the appropriate use of effective masks in addition to vaccination continues important to prevent new infections."
The study, funded by the National Institute of Allergy and Infectious Diseases, is the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT). The trial is a public-private partnership to develop an international coordinated research strategy for prioritizing and speeding development of the most promising treatments.
"Our ACTT-4 study demonstrates that a rigorous clinical trial not only brings relevant progress to science, but most importantly, it directly improves the care of patients hospitalized with COVID-19 worldwide," Dr. Kalil said.
The effort to find new and better treatments for COVID continues. He and his team currently are evaluating new immunomodulatory treatments with different mechanisms of action.
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