Subsequently, results from the 3 largest randomized clinical trials that evaluated CCP in hospitalized patients-RECOVERY, 18 CONCOR-1, 19 and REMAP-CAP 20-found no evidence of benefit for high-titer CCP in hospitalized patients with COVID-19. 8,9 The Panel reviewed the EAP analyses and determined that the data were not sufficient to establish the efficacy or safety of CCP due to potential confounding factors, the lack of randomization, and the lack of an untreated control group.ĭata from the initial randomized clinical trials that evaluated CCP, which were all underpowered, did not demonstrate the product’s efficacy for the treatment of hospitalized patients with COVID-19. Several retrospective analyses of the EAP data have indicated that patients who received high-titer CCP had a lower relative risk of death than patients who received low-titer CCP. The initial EUA for CCP for the treatment of hospitalized patients with COVID-19 was issued on the basis of retrospective, indirect evaluations of efficacy generated from the CCP EAP, which allowed CCP to be used regardless of titer. Expanded Access Program (EAP) for CCP, are summarized in Table 3b. Under the revised EUA, the use of CCP is no longer authorized for hospitalized patients who do not have immunosuppressive disease or who are not receiving immunosuppressive treatments.Ĭlinical data on the use of CCP for the treatment of COVID-19 in hospitalized, immunocompetent patients, including data from several randomized trials and the U.S. For Hospitalized, Immunocompetent Patients The current approaches to testing CCP titers do not account for potential differences in the neutralizing activity of CCP products against currently circulating variants.įurthermore, it is difficult to interpret the available data on the in vitro antiviral activity of CCP, since the published studies use a variety of assays to characterize the neutralizing activity of CCP, and the level of immunity to COVID-19 can vary across different donor populations.Many CCP clinical trials were completed before the Omicron surge, and their results may not inform the current clinical context.The current supply of CCP products in the United States was not generated from donors who had recovered from Omicron infection.This is due in part to the following factors: Although in vitro data suggest that the CCP collected from vaccinated and unvaccinated individuals who have recovered from Omicron infection exhibits neutralizing activity against the Omicron variant, 3-6 it is not possible to extrapolate the potential clinical efficacy of CCP in the current clinical context. The Omicron variant is the dominant SARS-CoV-2 variant currently circulating in the United States. Rationale Regarding the Use of COVID-19 Convalescent Plasma Collected Prior to the Emergence of the Omicron Variant There is insufficient evidence for the Panel to recommend either for or against the use of high-titer CCP that was collected after the emergence of Omicron for the treatment of immunocompromised patients and nonhospitalized, immunocompetent patients with COVID-19.
Plasma from donors who have recovered from COVID-19 may contain antibodies to SARS-CoV-2 that could help suppress viral replication.
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