Very few therapeutic options are available early in infectious disease epidemics with the exception of convalescent plasma. In August 2020, the U.S. FDA authorized COVID-19 convalescent plasma (CCP) for the treatment of hospitalized patients with COVID-19 based on a large observational study, which reported the risk of death was substantially lower in patients who received a higher titer CCP. Several more recently published randomized controlled trials, however, did not show CCP improved outcomes in patients with moderate to severe disease. In this randomized, multicenter, single-blind trial, 257 adult patients presenting to the emergency room (median age, 54 years) with one or more high risk factors for severe COVID-19 were treated with high titer CCP (1:641) within one week of symptom onset (median symptom duration of 4 days) and compared to 254 patients with similar baseline characteristics who received saline placebo. Disease progression was similar in both arms of the study—30% (77/257) of the patients in the CCP arm and 31.9% (81/254) in the placebo arm developed severe disease requiring either hospitalization, emergency care, or death. Furthermore, no differences were observed in secondary outcomes. CCP did not prevent the progression of disease in patients at high risk for severe illness. However, the arms were imbalanced among same day admission and CCP was admitted later than other successful outpatient trials. Additional data are urgently need to determine the ideal patient populations to benefit from CCP.
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