Dataset Information

Convalescent Plasma to Treat COVID-19: A Two-Center, Randomized, Double-Blind Clinical Trial.

ABSTRACT:

Background

The use of convalescent plasma (CP) has been considered for its immunological mechanisms that could benefit patients in moderate and severe stages of COVID-19. This study evaluated the safety and efficacy of the use of donor CP for COVID-19.

Material and methods

A double-blind, randomized controlled clinical trial was conducted from May to October 2020. Thirty-nine participants with moderate (II) and severe (III) stages of COVID-19 confirmed by RT-PCR were included. The study randomization rate was set at 3:1. CPs were chosen for application with a neutralizing antibody titer of ≥1:32.

Results

We observed a significantly lower 21-day post-transfusion mortality HR: 0.17 (95.0% CI [0.07-0.45, p < 0.001]) in the group receiving CP compared with the control group; protective units (PU) in the group receiving convalescent plasma after seven days were significantly higher (512 (32-16,384) vs. 96 (32-256), p = 0.01); the PAO₂/FIO₂ index showed a significant improvement in the group receiving CP (251.01 (109.4) vs. 109.2 (62.4), p < 0.001, in the control group).

Conclusion

CP is safe and effective, as it decreased mortality in the CP group compared with the control group.

SUBMITTER: Ventura-Enriquez Y

PROVIDER: S-EPMC9692718 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Convalescent Plasma to Treat COVID-19: A Two-Center, Randomized, Double-Blind Clinical Trial.

Ventura-Enríquez Yanet Y Cabello-Gutiérrez Carlos C Pérez-Calatayud Ángel Augusto ÁA Cortina-De la Rosa Evelyn E Fareli-González Christian Javier CJ Castillo-Juárez Paola P Carlos Alberto Peña-Pérez AP Zavaleta-Martínez Elí Omar EO Diaz-Padilla Elizabeth E Murrieta Sandra S Álvarez-Jiménez Violeta Deyanira VD Ponce-Medrano Juan Alberto Díaz JAD Casillas-Suárez Catalina C Ocampo-Ocampo María Angelica MA Vargas-De-León Cruz C Fernández-Sánchez Verónica V

Life (Basel, Switzerland) 20221102 11

Background: The use of convalescent plasma (CP) has been considered for its immunological mechanisms that could benefit patients in moderate and severe stages of COVID-19. This study evaluated the safety and efficacy of the use of donor CP for COVID-19. Material and methods: A double-blind, randomized controlled clinical trial was conducted from May to October 2020. Thirty-nine participants with moderate (II) and severe (III) stages of COVID-19 confirmed by RT-PCR were included. The study random ...[more]

PMID: 36362922

Similar Datasets

Project description:BackgroundAlthough frequently used in the early pandemic, data on the effectiveness of COVID-19 convalescent plasma (CCP) remain mixed. We investigated the effectiveness and safety of CCP in hospitalized COVID-19 patients in real-world practices during the first two waves of the pandemic in a multi-hospital healthcare system in Texas.Methods and findingsAmong 11,322 hospitalized patients with confirmed COVID-19 infection from July 1, 2020 to April 15, 2021, we included patients who received CCP and matched them with those who did not receive CCP within ±2 days of the transfusion date across sites within strata of sex, age groups, days and use of dexamethasone from hospital admission to the match date, and oxygen requirements 4-12 hours prior to the match date. Cox proportional hazards model estimated hazard ratios (HRs) and 95% confidence intervals (CIs) for effectiveness outcomes in a propensity score 1:1 matched cohort. Pre-defined safety outcomes were described. We included 1,245 patients each in the CCP treated and untreated groups. Oxygen support was required by 93% of patients at the baseline. The pre-defined primary effectiveness outcome of 28-day in-hospital all-cause mortality (HR = 0.85; 95%CI: 0.66,1.10) were similar between treatment groups. Sensitivity and stratified analyses found similar null results. CCP-treated patients were less likely to be discharged alive (HR = 0.82; 95%CI: 0.74, 0.91), and more likely to receive mechanical ventilation (HR = 1.48; 95%CI: 1.12, 1.96). Safety outcomes were rare and similar between treatment groups.ConclusionThe findings in this large, matched cohort of patients hospitalized with COVID-19 and mostly requiring oxygen support at the time of treatment, do not support a clinical benefit in 28-day in-hospital all-cause mortality for CCP. Future studies should assess the potential benefits with specifically high-titer units in perhaps certain subgroups of patients (e.g. those with early disease or immunocompromised).

Dataset Information

Convalescent Plasma to Treat COVID-19: A Two-Center, Randomized, Double-Blind Clinical Trial.

Background

Material and methods

Results

Conclusion

Publications

Convalescent Plasma to Treat COVID-19: A Two-Center, Randomized, Double-Blind Clinical Trial.

Similar Datasets

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