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Monoclonal antibody treatment taken by hospitalized COVID-19 patients reduces mortality

Monoclonal antibody treatment taken by patients hospitalized with COVID-19 did not improve recovery time but reduced deaths, according to a study published July 8 in The Lancet Respiratory Medicine.

The therapy, tixagevimab/cilgavimab, was developed and deployed rapidly in response to the pandemic. The data was analyzed as part of an NIH-sponsored international clinical trial, including a site at Duke that enrolled about 10% of study participants.

In the early days of COVID, around 25% of hospitalized patients died from their illness, and finding something that worked was imperative. Now, with better therapies, in addition to better population immunity from vaccination and previous infections, that number is down. We still have work to do, and trials like this help us find additional therapies that could benefit our patients. »

Thomas Holland, MD, co-lead author, infectious disease specialist and associate professor of medicine at Duke

Data on another successful approach, using the immune modulator baricitinib in combination with the antiviral remdesivir, was also recently reported in The Lancet Respiratory Medicine. Lead author Cameron Wolfe, MD is an infectious disease specialist and associate professor of medicine at Duke.

“The big picture is that monoclonal antibodies are a full-spectrum treatment,” Wolfe said. “They have a role in the prevention, treatment of early illnesses and hospitalized respiratory failure. We hope this could be another class of drugs for use in hospitals for COVID patients. »

In the tixagevimab/cilgavimab study, the placebo-controlled Phase 3 trial enrolled 1,455 patients and took place at 81 sites on four continents. Duke has enrolled 147 patients, making it the highest enrollment site.

Patients were randomized to receive an infusion of tixagevimab/cilgavimab or placebo, in addition to remdesivir and other standard care. By day 90, sustained recovery was achieved by 87% of people who received tixagevimab/cilgavimab and 84% of participants in the placebo group. Mortality was nearly 4% lower in the tixagevimab/cilgavimab group.

“One in three patients who would have died without the treatment survived after receiving the monoclonal antibodies,” said co-lead author Adit Ginde, MD, MPH, professor of emergency medicine at the University School of Medicine. of Colorado and an emergency department physician. at the University of Colorado’s UCHealth Hospital. “This is a remarkable sign of benefit and suggests that this treatment and other similar treatments can save lives in patients with severe COVID-19. »

In addition to Holland and Ginde, a full list of study authors is included in the study.

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