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.; Papageourgiou, G.; Geloven, N. van; Jordans, C.; Groeneveld, G.; Swaneveld, F.; Schoot, E. van der; Corbacho-Monne, M.; Ouchi, D.; Ferreira, F.P.; Malchair, P.; Videla, S.; Garcia, V.G.; Ruiz-Comellas, A.; Ramirez-Morros, A.; Codina, J.R.; Simon, R.A.; Grifols, J.R.; Blanco, J.; Blanco, I.; Ara, J.; Bassat, Q.; Clotet, B.; Baro, B.; Troxel, A.; Zwaginga, J.J.; Mitja, O.; Rijnders, B.J.A.; CoV-Early Study Grp; COnV-ert Study Grp

doi:doi:10.1038/s41467-022-29911-3

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 metaanalysis 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...Show moreData 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 metaanalysis 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.Show less

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