A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease (RECOVER): A structured summary of a study protocol for a randomised controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 21; no. 1; pp. 828 - 4
• Main Authors: Janssen, Maike, Schäkel, Ulrike, Djuka Fokou, Carine, Krisam, Johannes, Stermann, Jacek, Kriegsmann, Katharina, Haberbosch, Isabella, Novotny, Jan Philipp, Weber, Stefan, Vehreschild, Maria, Bornhäuser, Martin, Bullinger, Lars, Schmitt, Michael, Liebregts, Tobias, Dreger, Peter, Lorenz, Hanns-Martin, Plaszczyca, Anna, Bartenschlager, Ralf, Müller, Barbara, Kräusslich, Hans-Georg, Halama, Niels, Jäger, Dirk, Schlenk, Richard F., Leo, Albrecht, Meuer, Stefan, Weigand, Markus A., Motsch, Johann, Merle, Uta, Denkinger, Claudia M., Müller-Tidow, Carsten
• Format: Journal Article
• Language: English
• Published: England BioMed Central 06.10.2020; BMC
• Subjects: Aged; Antibodies, Viral - blood; Betacoronavirus - immunology; Betacoronavirus - isolation & purification; Clinical Trials, Phase II as Topic; Consent; Convalescence; convalescent plasma; Coronavirus Infections - diagnosis; Coronavirus Infections - immunology; Coronavirus Infections - therapy; COVID-19; early application; Ethics; Female; high-risk patients with severe disease; Humans; Immunization, Passive - methods; Letter; Male; Middle Aged; Monitoring, Physiologic - methods; Multicenter Studies as Topic; Pandemics; Plasma - immunology; Pneumonia, Viral - diagnosis; Pneumonia, Viral - immunology; Pneumonia, Viral - therapy; protocol; Randomised controlled trial; Randomized Controlled Trials as Topic; Risk Adjustment; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Severity of Illness Index; Writing; COVID-19; protocol; high-risk patients with severe disease; early application; Randomised controlled trial; convalescent plasma

Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of pla...