Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized controlled trial (PROTECT-Patient Trial)

Medical Division, Translational Research Department, South African National Blood Service, 1 Constantia Blvd, Roodepoort, 1715, South Africa. Karin.vandenberg@sanbs.org.za. Division of Clinical Haematology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Observatory, South Africa. Karin.vandenberg@sanbs.org.za. Division of Clinical Haematology, Department of Internal Medicine, University of the Free State, Bloemfontein, South Africa. Karin.vandenberg@sanbs.org.za. Medical Division, Translational Research Department, South African National Blood Service, 1 Constantia Blvd, Roodepoort, 1715, South Africa. Division of Clinical Haematology, Department of Internal Medicine, University of the Free State, Bloemfontein, South Africa. Operations Division, Operations Testing Department, South African National Blood Service, Roodepoort, South Africa. Department of Statistical Sciences, University of Cape Town, Observatory, South Africa. School of Clinical Medicine, University of the Free State, Bloemfontein, South Africa. Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Observatory, South Africa. Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory, South Africa. Mitchells Plain Hospital and the University of Cape Town's Department of Medicine, Faculty of Health Sciences, University of Cape Town, Observatory, South Africa. Division of Clinical Haematology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Observatory, South Africa. Operations Division, Processing Department, South African National Blood Service, Roodepoort, South Africa. National Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa. MRC Antibody Immunity Research Unit, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Department of Medicine, Walter Sisulu University, Livingstone Hospital, Gqeberha, South Africa. Capital Haematology Hospital and Bone Marrow Transplant Unit, Durban, South Africa. Centre for Respiratory Diseases and Meningitis (CRDM), National Institute for Communicable Diseases, Johannesburg, South Africa. Department of Virology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Life Westville Hospital, Westville, South Africa. Division of Infectious Diseases, Department of Internal Medicine, University of the Free State, Bloemfontein, South Africa. 3 Military Hospital and Department of Internal Medicine, University of the Free State, Bloemfontein, South Africa. Pulmonology and Critical Care, Universitas Academic Hospital and Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa. Francis Crick Institute, London, NW1 1AT, UK. Department of Infectious Diseases, Imperial College London, London, W12 0NN, UK. Division of Infectious Diseases and HIV Medicine, Department of Medicine, Groote Schuur Hospital and University of Cape Town, Observatory, South Africa.

Scientific reports. 2022;12(1):2552
Abstract
There is a need for effective therapy for COVID-19 pneumonia. Convalescent plasma has antiviral activity and early observational studies suggested benefit in reducing COVID-19 severity. We investigated the safety and efficacy of convalescent plasma in hospitalized patients with COVID-19 in a population with a high HIV prevalence and where few therapeutic options were available. We performed a double-blinded, multicenter, randomized controlled trial in one private and three public sector hospitals in South Africa. Adult participants with COVID-19 pneumonia requiring non-invasive oxygen were randomized 1:1 to receive a single transfusion of 200 mL of either convalescent plasma or 0.9% saline solution. The primary outcome measure was hospital discharge and/or improvement of ≥ 2 points on the World Health Organisation Blueprint Ordinal Scale for Clinical Improvement by day 28 of enrolment. The trial was stopped early for futility by the Data and Safety Monitoring Board. 103 participants, including 21 HIV positive individuals, were randomized at the time of premature trial termination: 52 in the convalescent plasma and 51 in the placebo group. The primary outcome occurred in 31 participants in the convalescent plasma group and and 32 participants in the placebo group (relative risk 1.03 (95% CI 0.77 to 1.38). Two grade 1 transfusion-related adverse events occurred. Participants who improved clinically received convalescent plasma with a higher median anti-SARS-CoV-2 neutralizing antibody titre compared with those who did not (298 versus 205 AU/mL). Our study contributes additional evidence for recommendations against the use of convalescent plasma for COVID-19 pneumonia. Safety and feasibility in this population supports future investigation for other indications.
Study details
Language : eng
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