In an 11-day, 584 patient, Phase III, open-label trial (NCT04292730), patients treated with a 5-day course of remdesivir were more likely to have at least a 2-point improvement on a seven-point scale that runs from death to not hospitalized compared to placebo (70% vs 61%) in hospitalized patients with moderate COVID-19. A 10-day course of remdesivir did not differ from placebo (65% vs 61%), although most patients did not receive a full 10-days of treatment. Patients in the standard of care group were more likely to receive lopinavir-ritonavir, corticosteroids, hydroxychloroquine/chloroquine, azithromycin or tocilizumab.
The FDA issued an emergency use authorization (EUA) for convalescent plasma, on 8/23/2020, for the treatment of hospitalized patients with COVID-19. The EUA was granted for any convalescent plasma product “collected by FDA registered blood establishments from individuals whose plasma contains anti-SARS-CoV-2 antibodies, and who meet all donor eligibility requirements." Fact sheets have been created for health care providers and patients. The documents include dosing instructions and potential adverse effects, such as allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.
In an unpublished, 35,322 patient, open-label trial, the seven-day mortality was 8.7% in patients treated with convalescent plasma within 3 days of diagnosis, and 11.9% if transfused four or more days later in patients hospitalized with COVID-19. Lower mortality was also seen with convalescent plasma that had higher antibody levels. Data from the trial was collected from patients treated through a convalescent plasma expanded access program for COVID-19 (NCT04338360).
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