Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden

DOI record: { "DOI": "10.1186/s13104-021-05847-7", "ISSN": [ "1756-0500" ], "URL": "http://dx.doi.org/10.1186/s13104-021-05847-7", "abstract": "<jats:title>Abstract</jats:title><jats:sec>\n <jats:title>Objective</jats:title>\n <jats:p>Convalescent plasma has been tried as therapy for various viral infections. Early observational studies of convalescent plasma treatment for hospitalized COVID-19 patients were promising, but randomized controlled studies were lacking at the time. The objective of this study was to investigate if convalescent plasma is beneficial to hospitalized patients with COVID-19.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>Hospitalized patients with confirmed COVID-19 and an oxygen saturation below 94% were randomized 1:1 to receive convalescent plasma in addition to standard of care or standard of care only. The primary outcome was number of days of oxygen treatment to keep saturation above 93% within 28 days from inclusion. The study was prematurely terminated when thirty-one of 100 intended patients had been included. The median time of oxygen treatment among survivors was 11 days (IQR 6–15) for the convalescent plasma group and 7 days (IQR 5–9) for the standard of care group (<jats:italic>p</jats:italic> = 0.4, median difference -4). Two patients in the convalescent plasma group and three patients in the standard of care group died (<jats:italic>p</jats:italic> = 0.64, OR 0.49, 95% CI 0.08–2.79). Thus no significant differences were observed between the groups.</jats:p>\n <jats:p><jats:italic>Trial registration</jats:italic> ClinicalTrials NCT04600440, retrospectively registered Oct 23, 2020.</jats:p>\n </jats:sec>", "alternative-id": [ "5847" ], "article-number": "440", "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "2 July 2021" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "12 November 2021" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "4 December 2021" }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "name": "Ethics", "order": 1 }, { "group": { "label": "Ethics approval and consent to participate", "name": "EthicsHeading" }, "name": "Ethics", "order": 2, "value": "The Swedish Ethical Review Authority approved the study (Reference Number #2020-01744, 2020-03595). Written informed consent was required from donors and patients on inclusion." }, { "group": { "label": "Consent to publish", "name": "EthicsHeading" }, "name": "Ethics", "order": 3, "value": "Not applicable." }, { "group": { "label": "Competing interests", "name": "EthicsHeading" }, "name": "Ethics", "order": 4, "value": "The authors declare no competing interests." } ], "author": [ { "ORCID": "http://orcid.org/0000-0002-8289-5949", "affiliation": [], "authenticated-orcid": false, "family": "Holm", "given": "Karin", "sequence": "first" }, { "affiliation": [], "family": "Lundgren", "given": "Maria N.", "sequence": "additional" }, { "affiliation": [], "family": "Kjeldsen-Kragh", "given": "Jens", "sequence": "additional" }, { "affiliation": [], "family": "Ljungquist", "given": "Oskar", "sequence": "additional" }, { "affiliation": [], "family": "Böttiger", "given": "Blenda", "sequence": "additional" }, { "affiliation": [], "family": "Wikén", "given": "Christian", "sequence": "additional" }, { "affiliation": [], "family": "Öberg", "given": "Jonas", "sequence": "additional" }, { "affiliation": [], "family": "Fernström", "given": "Nils", "sequence": "additional" }, { "affiliation": [], "family": "Rosendal", "given": "Ebba", "sequence": "additional" }, { "affiliation": [], "family": "Överby", "given": "Anna K.", "sequence": "additional" }, { "affiliation": [], "family": "Wigren Byström", "given": "Julia", "sequence": "additional" }, { "affiliation": [], "family": "Forsell", "given": "Mattias", "sequence": "additional" }, { "affiliation": [], "family": "Landin-Olsson", "given": "Mona", "sequence": "additional" }, { "affiliation": [], "family": "Rasmussen", "given": "Magnus", "sequence": "additional" } ], "clinical-trial-number": [ { "clinical-trial-number": "nct04600440", "registry": "10.18810/clinical-trials-gov" } ], "container-title": "BMC Research Notes", "container-title-short": "BMC Res Notes", "content-domain": { "crossmark-restriction": false, "domain": [ "link.springer.com" ] }, "created": { "date-parts": [ [ 2021, 12, 4 ] ], "date-time": "2021-12-04T09:02:48Z", "timestamp": 1638608568000 }, "deposited": { "date-parts": [ [ 2021, 12, 4 ] ], "date-time": "2021-12-04T21:41:30Z", "timestamp": 1638654090000 }, "funder": [ { "DOI": "10.13039/501100009780", "doi-asserted-by": "publisher", "name": "region skåne" } ], "indexed": { "date-parts": [ [ 2023, 1, 14 ] ], "date-time": "2023-01-14T10:53:58Z", "timestamp": 1673693638449 }, "is-referenced-by-count": 12, "issue": "1", "issued": { "date-parts": [ [ 2021, 12 ] ] }, "journal-issue": { "issue": "1", "published-print": { "date-parts": [ [ 2021, 12 ] ] } }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2021, 12, 1 ] ], "date-time": "2021-12-01T00:00:00Z", "timestamp": 1638316800000 } }, { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "vor", "delay-in-days": 3, "start": { "date-parts": [ [ 2021, 12, 4 ] ], "date-time": "2021-12-04T00:00:00Z", "timestamp": 1638576000000 } } ], "link": [ { "URL": "https://link.springer.com/content/pdf/10.1186/s13104-021-05847-7.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/article/10.1186/s13104-021-05847-7/fulltext.html", "content-type": "text/html", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/content/pdf/10.1186/s13104-021-05847-7.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "297", "original-title": [], "prefix": "10.1186", "published": { "date-parts": [ [ 2021, 12 ] ] }, "published-online": { "date-parts": [ [ 2021, 12, 4 ] ] }, "published-print": { "date-parts": [ [ 2021, 12 ] ] }, "publisher": "Springer Science and Business Media LLC", "reference": [ { "DOI": "10.1016/j.autrev.2020.102554", "author": "M Rojas", "doi-asserted-by": "publisher", "issue": "7", "journal-title": "Autoimmun Rev", "key": "5847_CR1", "unstructured": "Rojas M, Rodríguez Y, Monsalve DM, Acosta-Ampudia Y, Camacho B, Gallo JE, et al. 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