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

{ 'indexed': { 'date-parts': [[2022, 12, 21]], 'date-time': '2022-12-21T02:35:13Z', 'timestamp': 1671590113233}, 'reference-count': 43, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2022, 2, 15]], 'date-time': '2022-02-15T00:00:00Z', 'timestamp': 1644883200000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2022, 2, 15]], 'date-time': '2022-02-15T00:00:00Z', 'timestamp': 1644883200000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [ {'name': 'National Institute of Health, South Africa', 'award': ['K43TW011421']}, {'name': 'NIH Fogarty International Center Training Grant', 'award': ['1D43-TW010345']}, { 'name': 'South African Research Chairs Initiative of the Department of Science and ' 'Innovation and the National Research Foundation', 'award': ['98341']}, { 'DOI': '10.13039/501100000289', 'name': 'Cancer Research UK', 'doi-asserted-by': 'publisher', 'award': ['FC0010218']}, { 'DOI': '10.13039/501100000265', 'name': 'Medical Research Council', 'doi-asserted-by': 'publisher', 'award': ['FC0010218']}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'abstract': '<jats:title>Abstract</jats:title><jats:p>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\xa0mL of either convalescent plasma or ' '0.9% saline solution. The primary outcome measure was hospital discharge and/or improvement ' 'of\u2009≥\u20092 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\xa0participants 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\xa0AU/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.</jats:p>', 'DOI': '10.1038/s41598-022-06221-8', 'type': 'journal-article', 'created': {'date-parts': [[2022, 2, 15]], 'date-time': '2022-02-15T11:03:01Z', 'timestamp': 1644922981000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 11, 'title': 'Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized ' 'controlled trial (PROTECT-Patient Trial)', 'prefix': '10.1038', 'volume': '12', 'author': [ {'given': 'Karin', 'family': 'van den Berg', 'sequence': 'first', 'affiliation': []}, {'given': 'Tanya Nadia', 'family': 'Glatt', 'sequence': 'additional', 'affiliation': []}, {'given': 'Marion', 'family': 'Vermeulen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Francesca', 'family': 'Little', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ronel', 'family': 'Swanevelder', 'sequence': 'additional', 'affiliation': []}, {'given': 'Claire', 'family': 'Barrett', 'sequence': 'additional', 'affiliation': []}, {'given': 'Richard', 'family': 'Court', 'sequence': 'additional', 'affiliation': []}, {'given': 'Marise', 'family': 'Bremer', 'sequence': 'additional', 'affiliation': []}, {'given': 'Cynthia', 'family': 'Nyoni', 'sequence': 'additional', 'affiliation': []}, {'given': 'Avril', 'family': 'Swarts', 'sequence': 'additional', 'affiliation': []}, {'given': 'Cordelia', 'family': 'Mmenu', 'sequence': 'additional', 'affiliation': []}, {'given': 'Thomas', 'family': 'Crede', 'sequence': 'additional', 'affiliation': []}, {'given': 'Gerdien', 'family': 'Kritzinger', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jonathan', 'family': 'Naude', 'sequence': 'additional', 'affiliation': []}, {'given': 'Patryk', 'family': 'Szymanski', 'sequence': 'additional', 'affiliation': []}, {'given': 'James', 'family': 'Cowley', 'sequence': 'additional', 'affiliation': []}, {'given': 'Thandeka', 'family': 'Moyo-Gwete', 'sequence': 'additional', 'affiliation': []}, {'given': 'Penny L.', 'family': 'Moore', 'sequence': 'additional', 'affiliation': []}, {'given': 'John', 'family': 'Black', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jaimendra', 'family': 'Singh', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jinal N.', 'family': 'Bhiman', 'sequence': 'additional', 'affiliation': []}, {'given': 'Prinita', 'family': 'Baijnath', 'sequence': 'additional', 'affiliation': []}, {'given': 'Priyesh', 'family': 'Mody', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jacques', 'family': 'Malherbe', 'sequence': 'additional', 'affiliation': []}, {'given': 'Samantha', 'family': 'Potgieter', 'sequence': 'additional', 'affiliation': []}, {'given': 'Cloete', 'family': 'van Vuuren', 'sequence': 'additional', 'affiliation': []}, {'given': 'Shaun', 'family': 'Maasdorp', 'sequence': 'additional', 'affiliation': []}, {'given': 'Robert J.', 'family': 'Wilkinson', 'sequence': 'additional', 'affiliation': []}, {'given': 'Vernon J.', 'family': 'Louw', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sean', 'family': 'Wasserman', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2022, 2, 15]]}, 'reference': [ { 'issue': '8', 'key': '6221_CR1', 'doi-asserted-by': 'publisher', 'first-page': '693', 'DOI': '10.1056/NEJMoa2021436', 'volume': '384', 'author': 'P Horby', 'year': '2021', 'unstructured': 'Horby, P. et al. 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