Antibody therapy gets EUA, studies show pandemic's effects on emergency care
Sotrovimab received an emergency use authorization (EUA) for some high-risk outpatients with COVID-19, and multiple studies found changed patterns in cardiac emergencies and care associated with the pandemic.
The FDA gave a new monoclonal antibody therapy emergency use authorization for treatment of COVID-19 in outpatients on May 26. Sotrovimab can be used for patients ages 12 years and older who have a positive SARS-CoV-2 test, mild to moderate symptoms, and high risk for progression to severe disease, including hospitalization or death. According to an FDA press release, the authorization was based on an interim analysis of a randomized trial of adult patients treated within five days of COVID-19 symptom onset. Hospitalization or death occurred in 21 of 292 patients given placebo (7%) compared to 3 of 291 treated with sotrovimab (1%). The drug is not authorized for patients who are hospitalized or require oxygen due to COVID-19.
Several recent studies assessed how the pandemic affected other medical conditions and care. Paramedics in Los Angeles responded to more out-of-hospital cardiac arrests in the spring of 2020 versus 2018 and 2019, according to a study published by the Journal of the American Heart Association on June 1. Rates of defibrillation and return of spontaneous circulation were also lower. “It is critical that public health messaging stress that emergency care should not be delayed,” the authors concluded. Similarly, a study of EMS calls in Boston, published by Health Affairs on May 26, found that out-of-hospital cardiac arrests increased, while cardiac-related calls decreased, during the first wave of the pandemic. A California health system found that hospitalizations for acute myocardial infarction and stroke declined during the first COVID-19 surge, but not during the larger surge of late 2020, according to a research letter published by JAMA on June 2.* “These patterns may reflect changing patient attitudes during the COVID-19 pandemic or the success of health system and public health campaigns to reassure patients about the safety of seeking emergency care when needed,” the authors said. Finally, an analysis of one U.S. health system's OB/GYN care projected a surge in births this summer. The study, published by JAMA Network Open on June 3, found a decrease in conceptions after the shutdown in March 2020, followed by a steadily increasing number of pregnancies.
In other COVID-19 news, the NIH's treatment guidelines panel revised its recommendations on the use of baricitinib on May 27. For hospitalized COVID-19 patients on high-flow oxygen or noninvasive ventilation who show evidence of clinical progression or increased inflammation, the panel now recommends either baricitinib or tocilizumab in combination with either dexamethasone alone or dexamethasone plus remdesivir. The panel had previously recommended baricitinib with remdesivir only in cases where corticosteroids could not be used, and this is still the recommendation for patients on supplemental oxygen. Otherwise, the panel found insufficient evidence for the use of baricitinib in these patients, as well as those on invasive ventilation. The panel recommends against using baricitinib with tocilizumab outside of a clinical trial. The recommendations were based on the results of the COV-BARRIER trial, which were published as a non-peer-reviewed preprint on May 3.
*This sentence has been corrected to accurately report the location of the study.