Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

{ 'indexed': {'date-parts': [[2024, 8, 9]], 'date-time': '2024-08-09T05:54:10Z', 'timestamp': 1723182850078}, 'reference-count': 72, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2021, 11, 20]], 'date-time': '2021-11-20T00:00:00Z', 'timestamp': 1637366400000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2021, 11, 20]], 'date-time': '2021-11-20T00:00:00Z', 'timestamp': 1637366400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [ { 'DOI': '10.13039/501100001711', 'name': 'swiss national science foundation', 'doi-asserted-by': 'crossref', 'award': ['31CA30_196190']}, { 'DOI': '10.13039/100009827', 'name': 'laura and john arnold foundation', 'doi-asserted-by': 'publisher'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'published-print': {'date-parts': [[2021, 12]]}, 'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>Convalescent plasma has been widely used to treat COVID-19 and is ' 'under investigation in numerous randomized clinical trials, but results are publicly ' 'available only for a small number of trials. The objective of this study was to assess the ' 'benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause ' 'mortality in patients with COVID-19, using data from all available randomized clinical ' 'trials, including unpublished and ongoing trials (Open Science Framework, <jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" ' 'xlink:href="https://doi.org/10.17605/OSF.IO/GEHFX">https://doi.org/10.17605/OSF.IO/GEHFX</jats:ext-link>).</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>In this collaborative systematic review and meta-analysis, clinical ' 'trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), ' 'the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, ' '2021. Investigators of trials registered by March 1, 2021, without published results were ' 'contacted via email. Eligible were ongoing, discontinued and completed randomized clinical ' 'trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, ' 'regardless of setting or treatment schedule. Aggregated mortality data were extracted from ' 'publications or provided by investigators of unpublished trials and combined using the ' 'Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of ' 'unpublished trials to the overall evidence.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>A total of 16,477 patients were included in 33 trials (20 unpublished ' 'with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized ' 'patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 ' 'trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 ' 'control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 ' '(95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance ' '(I<jats:sup>2</jats:sup>\u2009=\u20090%). The RECOVERY trial had 69.8% and the unpublished ' 'evidence 25.3% of the weight in the meta-analysis.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Convalescent plasma treatment of patients with COVID-19 did not ' 'reduce all-cause mortality. These results provide strong evidence that convalescent plasma ' 'treatment for patients with COVID-19 should not be used outside of randomized trials. ' 'Evidence synthesis from collaborations among trial investigators can inform both evidence ' 'generation and evidence application in patient care.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1186/s12879-021-06829-7', 'type': 'journal-article', 'created': { 'date-parts': [[2021, 11, 20]], 'date-time': '2021-11-20T11:02:28Z', 'timestamp': 1637406148000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 45, 'title': 'Association between convalescent plasma treatment and mortality in COVID-19: a collaborative ' 'systematic review and meta-analysis of randomized clinical trials', 'prefix': '10.1186', 'volume': '21', 'author': [ {'given': 'Cathrine', 'family': 'Axfors', 'sequence': 'first', 'affiliation': []}, {'given': 'Perrine', 'family': 'Janiaud', 'sequence': 'additional', 'affiliation': []}, {'given': 'Andreas M.', 'family': 'Schmitt', 'sequence': 'additional', 'affiliation': []}, {'given': 'Janneke', 'family': 'van’t Hooft', 'sequence': 'additional', 'affiliation': []}, {'given': 'Emily R.', 'family': 'Smith', 'sequence': 'additional', 'affiliation': []}, {'given': 'Noah A.', 'family': 'Haber', 'sequence': 'additional', 'affiliation': []}, {'given': 'Akin', 'family': 'Abayomi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Manal', 'family': 'Abduljalil', 'sequence': 'additional', 'affiliation': []}, {'given': 'Abdulkarim', 'family': 'Abdulrahman', 'sequence': 'additional', 'affiliation': []}, {'given': 'Yeny', 'family': 'Acosta-Ampudia', 'sequence': 'additional', 'affiliation': []}, {'given': 'Manuela', 'family': 'Aguilar-Guisado', 'sequence': 'additional', 'affiliation': []}, {'given': 'Farah', 'family': 'Al-Beidh', 'sequence': 'additional', 'affiliation': []}, {'given': 'Marissa M.', 'family': 'Alejandria', 'sequence': 'additional', 'affiliation': []}, {'given': 'Rachelle N.', 'family': 'Alfonso', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mohammad', 'family': 'Ali', 'sequence': 'additional', 'affiliation': []}, {'given': 'Manaf', 'family': 'AlQahtani', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alaa', 'family': 'AlZamrooni', 'sequence': 'additional', 'affiliation': []}, {'given': 'Juan-Manuel', 'family': 'Anaya', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mark Angelo C.', 'family': 'Ang', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ismael F.', 'family': 'Aomar', 'sequence': 'additional', 'affiliation': []}, {'given': 'Luis E.', 'family': 'Argumanis', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alexander', 'family': 'Averyanov', 'sequence': 'additional', 'affiliation': []}, {'given': 'Vladimir P.', 'family': 'Baklaushev', 'sequence': 'additional', 'affiliation': []}, {'given': 'Olga', 'family': 'Balionis', 'sequence': 'additional', 'affiliation': []}, {'given': 'Thomas', 'family': 'Benfield', 'sequence': 'additional', 'affiliation': []}, {'given': 'Scott', 'family': 'Berry', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nadia', 'family': 'Birocco', 'sequence': 'additional', 'affiliation': []}, {'given': 'Lynn B.', 'family': 'Bonifacio', 'sequence': 'additional', 'affiliation': []}, {'given': 'Asha C.', 'family': 'Bowen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Abbie', 'family': 'Bown', 'sequence': 'additional', 'affiliation': []}, {'given': 'Carlos', 'family': 'Cabello-Gutierrez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Bernardo', 'family': 'Camacho', 'sequence': 'additional', 'affiliation': []}, {'given': 'Adrian', 'family': 'Camacho-Ortiz', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sally', 'family': 'Campbell-Lee', 'sequence': 'additional', 'affiliation': []}, {'given': 'Damon H.', 'family': 'Cao', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ana', 'family': 'Cardesa', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jose M.', 'family': 'Carnate', 'sequence': 'additional', 'affiliation': []}, {'given': 'German Jr. J.', 'family': 'Castillo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Rossana', 'family': 'Cavallo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Fazle R.', 'family': 'Chowdhury', 'sequence': 'additional', 'affiliation': []}, {'given': 'Forhad U. 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Results ' 'availability and timeliness of registered COVID-19 clinical trials: a ' 'cross-sectional study. medRxiv. 2021;2021.04.07.21255071.', 'DOI': '10.1101/2021.04.07.21255071'}], 'container-title': 'BMC Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-021-06829-7.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1186/s12879-021-06829-7/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-021-06829-7.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 11, 20]], 'date-time': '2021-11-20T23:03:18Z', 'timestamp': 1637449398000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06829-7'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 11, 20]]}, 'references-count': 72, 'journal-issue': {'issue': '1', 'published-print': {'date-parts': [[2021, 12]]}}, 'alternative-id': ['6829'], 'URL': 'http://dx.doi.org/10.1186/s12879-021-06829-7', 'relation': {}, 'ISSN': ['1471-2334'], 'subject': [], 'container-title-short': 'BMC Infect Dis', 'published': {'date-parts': [[2021, 11, 20]]}, 'assertion': [ { 'value': '21 July 2021', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '28 October 2021', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '20 November 2021', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'Not applicable.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'Not applicable.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': 'During the conduct of the study, the following is reported: Dr. Berry reports ' 'being employee with ownership role at Berry Consultants (receives payments for ' 'statistical modeling and design of REMAP-CAP). Dr. Castillo reports grants from ' 'DOST PCHRD. Dr. Daly reports grants from Medical Research Future Fund ' '(Australian Govt) and RBWH. Dr. Denkinger reports grants from German Ministry ' 'for Education and Research. Dr. Dumagay reports grants from Philippine Council ' 'for Health Research and Development. Dr. Dunachie reports grants from UK ' 'Department of Health and Social Care, grants from UK National Institute of ' 'Health Research. Dr. Gauiran reports grants from Department of Science and ' 'Technology—Philippine Council for Health Research and Development. Dr. Gordon ' 'reports grants from NIHR, grants from NIHR Research Professorship ' '(RP-2015-06-18), and non-financial support from NIHR Clinical Research Network. ' 'Dr. Higgins reports grants from NHMRC and from the Minderoo Foundation. Dr. ' 'Hills reports grants from Health Research Council of New Zealand. Dr. Holm ' 'reports grants from Swedish Government Funds for Clinical Research (ALF). Dr. ' 'Janssen and Dr. Müller-Tidow report grants from the Federal Ministry of ' 'Education and Research in Germany (BMBF) to the RECOVER clinical trial. Dr. ' 'Krapp reports grants from Department of Foreign Affairs, Trade, and Development ' 'of Canada, grants from Fundación Telefónica del Perú. Dr. J. Lim reports grants ' 'from the Department of Science and Technology, Philippine Council for Health ' 'Research and Development. Dr. Lucero reports grants from Philippine Council for ' 'Health Research and Development. Dr Manrique reports economic support from ' 'Grupo ISA Intercolombia for the project development of trial NCT04332835. Drs. ' 'McQuilten and Wood report grants from Medical Research Future Fund. Dr. McVerry ' 'reports grants from The Pittsburgh Foundation, Translational Breast Cancer ' 'Research Consortium, and from UPMC Learning While Doing Program. Mr. Mouncey ' 'reports grants from National Institute for Health Research and from the ' 'European Union FP7: PREPARE. Dr. Najdovski reports payment from KUL Leuven to ' 'Belgian Red Cross for supply of convalescent plasma. Dr. Nichol reports grants ' 'from Health Research Board of Ireland. Dr. D. Roberts reports grants from the ' 'National Institute for Health (UKRIDHSC COVID-19 Rapid Response Rolling ' 'Call—Grant Reference Number COV19-RECPLAS) and the European Commission ' '(SUPPORT-E #101015756). Dr. Rowan reports grants from the European Commission ' 'and from the UK National Institute for Health Research. Dr. Shankar-Hari ' 'reports grants from National Institute for Health Research UK, grants from ' 'UKRI-National Institute for Health Research UK. Dr. Turgeon reports grants from ' 'Canadian Institutes of Health Research. Dr. Venkatesh reports grants from ' 'Baxter. Dr. Webb reports grants from National Health and Medical Research ' 'Council, grants from Minderoo Foundation. Dr. Zacharowski reports grants from ' 'EU Horizon 2020. The ASCOT trial team (Drs Bowen, Daly, Davis, Denholm, ' 'Hammond, Jha, L. Lim, McQuilten, Molton, Morpeth, O’Sullivan, Paterson, Perry, ' 'Price, Rees, Roberts, Rogers, Sasadeusz, Snelling, Tong, Venkatesh, Wood) is ' 'funded by grants from from Royal Brisbane and Women’s Hospital Foundation, ' 'Pratt Foundation, Minderoo Foundation, BHP Foundation, Hospital Research ' 'Foundation, Macquarie Group Foundation, Health Research Council of New Zealand, ' 'Australian Partnership for Preparedness Research on Infectious Disease ' 'Emergencies (APPRISE), and the collection and supply of convalescent plasma was ' 'conducted within Lifeblood’s funding arrangements. The CONFIDENT trial is ' 'funded by the Belgian KCE (blood establishments received payment for the ' 'convalescent plasma supplied in the clinical trial). REMAP-CAP was supported in ' 'part by funding from UKRIDHSC COVID-19 Rapid Response Rolling Call (Grant ' 'Reference Number COV19-RECPLAS). Collection of convalescent plasma for ' 'REMAP-CAP was funded by the Department of Health and Social Care, UK. The ' 'IRCT20200310046736N1 trial was supported by the Ahvaz Jundishapur University of ' 'Medical Sciences (Grant No. R.AJUMS.REC.1399.003, Dr. Pouladzadeh). The ' 'PC-COVID-19 Group is supported by the Universidad del Rosario, IDCBIS, ISA ' 'Group and Suramericana (Colombia). Outside the submitted work, the following is ' 'reported: Dr. Axfors reports postdoctoral grants from the Knut and Alice ' 'Wallenberg Foundation, Uppsala University, the Swedish Society of Medicine, the ' 'Blanceflor Foundation, and the Sweden-America Foundation. Dr. Aomar reports ' 'personal fees from SOBI, GEDEON RICHTER, and GSK. Dr. Benfield reports grants ' 'from Novo Nordisk Foundation, Simonsen Foundation, Lundbeck Foundation, Kai ' 'Hansen Foundation, Erik and Susanna Olesen’s Charitable Fund; grants and ' 'personal fees from GSK, Pfizer, Gilead; and personal fees from Boehringer ' 'Ingelheim, MSD, and Pentabase ApS. Dr. Estcourt reports being an investigator ' 'on the RECOVERY trial. Dr. Gordon reports personal fees from GlaxoSmithKline, ' 'Bristol Myers Squibb, and 30 Respiratory. Dr. Jha reports grants and personal ' 'fees from Baxter Healthcare, personal fees from Astra Zeneca, grants from ' 'NephroPlus. Dr. Laterre reports personal fees from Adrenomed. Dr. McVerry ' 'reports grants from NIH/NHLBI and Bayer Pharmaceuticals, Inc. Dr. Mondragon ' 'reports financial activities outside the submitted work (employment at Johnson ' '& Johnson). Dr. Perry reports partner being employed at CSL and owning shares ' 'in CSL. Dr. Paterson reports involvement with ALLIANCE trial of COVID-19 ' 'treatments. Dr. J. Roberts reports other COVID-19 related trials (in different ' 'patient groups): tocilizumab in ICU patients; hydroxychloroquine dosing in ICU ' 'patients; planned study of remdesivir pharmacokinetics in patients during ' 'expanded access program; and in silico evaluation of ivermectin dosing. Dr ' 'Sasadeusz reports grants from various Pharma companies including Gilead ' 'Sciences, Abvvie, Merck, and Takeda. Dr. Zacharowski reports personal fees from ' 'Biotest AG, CSL Behring, GE Heathcare, and is President of the ESAIC.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '1170'}