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Meta-Analysis
. 2022 May 11;13(1):2583.
doi: 10.1038/s41467-022-29911-3.

Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients

Collaborators, Affiliations
Meta-Analysis

Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients

Pere Millat-Martinez et al. Nat Commun. .

Erratum in

  • Author Correction: Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients.
    Millat-Martinez P, Gharbharan A, Alemany A, Rokx C, Geurtsvankessel C, Papageorgiou G, van Geloven N, Jordans C, Groeneveld G, Swaneveld F, van der Schoot E, Corbacho-Monné M, Ouchi D, Piccolo Ferreira F, Malchair P, Videla S, García García V, Ruiz-Comellas A, Ramírez-Morros A, Rodriguez Codina J, Amado Simon R, Grifols JR, Blanco J, Blanco I, Ara J, Bassat Q, Clotet B, Baro B, Troxel A, Zwaginga JJ, Mitjà O, Rijnders BJA; CoV-Early study group; COnV-ert study group. Millat-Martinez P, et al. Nat Commun. 2024 May 22;15(1):4352. doi: 10.1038/s41467-024-48645-y. Nat Commun. 2024. PMID: 38778041 Free PMC article. No abstract available.

Abstract

Data on convalescent plasma (CP) treatment in COVID-19 outpatients are scarce. We aimed to assess whether CP administered during the first week of symptoms reduced the disease progression or risk of hospitalization of outpatients. Two multicenter, double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when <20% of recruitment target was achieved. A Bayesian-adaptive individual patient data meta-analysis was implemented. Outpatients aged ≥50 years and symptomatic for ≤7days were included. The intervention consisted of 200-300mL of CP with a predefined minimum level of antibodies. Primary endpoints were a 5-point disease severity scale and a composite of hospitalization or death by 28 days. Amongst the 797 patients included, 390 received CP and 392 placebo; they had a median age of 58 years, 1 comorbidity, 5 days symptoms and 93% had negative IgG antibody-test. Seventy-four patients were hospitalized, 6 required mechanical ventilation and 3 died. The odds ratio (OR) of CP for improved disease severity scale was 0.936 (credible interval (CI) 0.667-1.311); OR for hospitalization or death was 0.919 (CI 0.592-1.416). CP effect on hospital admission or death was largest in patients with ≤5 days of symptoms (OR 0.658, 95%CI 0.394-1.085). CP did not decrease the time to full symptom resolution.

Trial registration: Clinicaltrials.gov NCT04621123 and NCT04589949.

Registration: NCT04621123 and NCT04589949 on https://www.

Clinicaltrials: gov.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1. CONSORT flow diagram.
Figure shows the CONSORT flow diagram of the COMPILEhome patients. 833 patients were screened at a study site and 782 were included for analysis.
Fig. 2
Fig. 2. Distribution for COVID-19 severity at 28 days.
CP Convalescent plasma. Figure shows the distribution of the outcome of the patients in the 28 days after inclusion across the 5-point disease severity scale: 1 = recovered before day 8 after transfusion, 2 = continued symptoms after day 7, 3 = hospital admission, 4 = invasive ventilation, 5 = death. Moving from lighter to darker shading represents increasing scores on the severity scale. The darker shade includes point 4 and 5 of the scale (invasive ventilation or death).
Fig. 3
Fig. 3. Time to full symptom resolution up to day 28 (end of follow-up).
CP Convalescent plasma. Log-rank test p = 0.66. The dotted error bars represent the 95% CI.

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