Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19: a randomized clinical trial

{ 'indexed': {'date-parts': [[2023, 1, 13]], 'date-time': '2023-01-13T05:54:39Z', 'timestamp': 1673589279324}, 'reference-count': 37, 'publisher': 'Springer Science and Business Media LLC', 'license': [ { 'start': { 'date-parts': [[2022, 12, 29]], 'date-time': '2022-12-29T00:00:00Z', 'timestamp': 1672272000000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2022, 12, 29]], 'date-time': '2022-12-29T00:00:00Z', 'timestamp': 1672272000000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [{'name': 'The Federal Ministry of Education and Research, Germany'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'abstract': '<jats:title>Abstract</jats:title><jats:p>Patients with cancer are at high risk of severe ' 'coronavirus disease 2019 (COVID-19), with high morbidity and mortality. Furthermore, impaired ' 'humoral response renders severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ' 'vaccines less effective and treatment options are scarce. Randomized trials using ' 'convalescent plasma are missing for high-risk patients. Here, we performed a randomized, ' 'open-label, multicenter trial (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ' 'ext-link-type="uri" ' 'xlink:href="https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE">https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE</jats:ext-link>) ' 'in hospitalized patients with severe COVID-19 (<jats:italic>n</jats:italic>\u2009=\u2009134) ' 'within four risk groups ((1) cancer (<jats:italic>n</jats:italic>\u2009=\u200956); (2) ' 'immunosuppression (<jats:italic>n</jats:italic>\u2009=\u200916); (3) laboratory-based risk ' 'factors (<jats:italic>n</jats:italic>\u2009=\u200936); and (4) advanced age ' '(<jats:italic>n</jats:italic>\u2009=\u200926)) randomized to standard of care (control arm) ' 'or standard of care plus convalescent/vaccinated anti-SARS-CoV-2 plasma (plasma arm). No ' 'serious adverse events were observed related to the plasma treatment. Clinical improvement as ' 'the primary outcome was assessed using a seven-point ordinal scale. Secondary outcomes were ' 'time to discharge and overall survival. For the four groups combined, those receiving plasma ' 'did not improve clinically compared with those in the control arm (hazard ratio (HR)\u2009' '=\u20091.29; <jats:italic>P</jats:italic>\u2009=\u20090.205). However, patients with cancer ' 'experienced a shortened median time to improvement (HR\u2009=\u20092.50; ' '<jats:italic>P</jats:italic>\u2009=\u20090.003) and superior survival with plasma treatment ' 'versus the control arm (HR\u2009=\u20090.28; <jats:italic>P</jats:italic>\u2009=\u20090.042). ' 'Neutralizing antibody activity increased in the plasma cohort but not in the control cohort ' 'of patients with cancer (<jats:italic>P</jats:italic>\u2009=\u20090.001). Taken together, ' 'convalescent/vaccinated plasma may improve COVID-19 outcomes in patients with cancer who are ' 'unable to intrinsically generate an adequate immune response.</jats:p>', 'DOI': '10.1038/s43018-022-00503-w', 'type': 'journal-article', 'created': { 'date-parts': [[2022, 12, 29]], 'date-time': '2022-12-29T17:06:50Z', 'timestamp': 1672333610000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or ' 'solid cancer and severe COVID-19: a randomized clinical trial', 'prefix': '10.1038', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-7216-7067', 'authenticated-orcid': False, 'given': 'Claudia M.', 'family': 'Denkinger', 'sequence': 'first', 'affiliation': []}, {'given': 'Maike', 'family': 'Janssen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ulrike', 'family': 'Schäkel', 'sequence': 'additional', 'affiliation': []}, {'given': 'Julia', 'family': 'Gall', 'sequence': 'additional', 'affiliation': []}, {'given': 'Albrecht', 'family': 'Leo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Patrick', 'family': 'Stelmach', 'sequence': 'additional', 'affiliation': []}, {'given': 'Stefan F.', 'family': 'Weber', 'sequence': 'additional', 'affiliation': []}, {'given': 'Johannes', 'family': 'Krisam', 'sequence': 'additional', 'affiliation': []}, {'given': 'Lukas', 'family': 'Baumann', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jacek', 'family': 'Stermann', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0003-1386-3350', 'authenticated-orcid': False, 'given': 'Uta', 'family': 'Merle', 'sequence': 'additional', 'affiliation': []}, {'given': 'Markus A.', 'family': 'Weigand', 'sequence': 'additional', 'affiliation': []}, {'given': 'Christian', 'family': 'Nusshag', 'sequence': 'additional', 'affiliation': []}, {'given': 'Lars', 'family': 'Bullinger', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Jens-Florian', 'family': 'Schrezenmeier', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-5916-3029', 'authenticated-orcid': False, 'given': 'Martin', 'family': 'Bornhäuser', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nael', 'family': 'Alakel', 'sequence': 'additional', 'affiliation': []}, {'given': 'Oliver', 'family': 'Witzke', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-3819-9540', 'authenticated-orcid': False, 'given': 'Timo', 'family': 'Wolf', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Maria J. G. T.', 'family': 'Vehreschild', 'sequence': 'additional', 'affiliation': []}, {'given': 'Stefan', 'family': 'Schmiedel', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0003-2836-9224', 'authenticated-orcid': False, 'given': 'Marylyn M.', 'family': 'Addo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Felix', 'family': 'Herth', 'sequence': 'additional', 'affiliation': []}, {'given': 'Michael', 'family': 'Kreuter', 'sequence': 'additional', 'affiliation': []}, {'given': 'Phil-Robin', 'family': 'Tepasse', 'sequence': 'additional', 'affiliation': []}, {'given': 'Bernd', 'family': 'Hertenstein', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mathias', 'family': 'Hänel', 'sequence': 'additional', 'affiliation': []}, {'given': 'Anke', 'family': 'Morgner', 'sequence': 'additional', 'affiliation': []}, {'given': 'Michael', 'family': 'Kiehl', 'sequence': 'additional', 'affiliation': []}, {'given': 'Olaf', 'family': 'Hopfer', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mohammad-Amen', 'family': 'Wattad', 'sequence': 'additional', 'affiliation': []}, {'given': 'Carl C.', 'family': 'Schimanski', 'sequence': 'additional', 'affiliation': []}, {'given': 'Cihan', 'family': 'Celik', 'sequence': 'additional', 'affiliation': []}, {'given': 'Thorsten', 'family': 'Pohle', 'sequence': 'additional', 'affiliation': []}, {'given': 'Matthias', 'family': 'Ruhe', 'sequence': 'additional', 'affiliation': []}, {'given': 'Winfried V.', 'family': 'Kern', 'sequence': 'additional', 'affiliation': []}, {'given': 'Anita', 'family': 'Schmitt', 'sequence': 'additional', 'affiliation': []}, {'given': 'Hanns-Martin', 'family': 'Lorenz', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-6923-0590', 'authenticated-orcid': False, 'given': 'Margarida', 'family': 'Souto-Carneiro', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mary', 'family': 'Gaeddert', 'sequence': 'additional', 'affiliation': []}, {'given': 'Niels', 'family': 'Halama', 'sequence': 'additional', 'affiliation': []}, {'given': 'Stefan', 'family': 'Meuer', 'sequence': 'additional', 'affiliation': []}, {'given': 'Hans-Georg', 'family': 'Kräusslich', 'sequence': 'additional', 'affiliation': []}, {'given': 'Barbara', 'family': 'Müller', 'sequence': 'additional', 'affiliation': []}, {'given': 'Paul', 'family': 'Schnitzler', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sylvia', 'family': 'Parthé', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-5601-9307', 'authenticated-orcid': False, 'given': 'Ralf', 'family': 'Bartenschlager', 'sequence': 'additional', 'affiliation': []}, {'given': 'Martina', 'family': 'Gronkowski', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jennifer', 'family': 'Klemmer', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-1579-1509', 'authenticated-orcid': False, 'given': 'Michael', 'family': 'Schmitt', 'sequence': 'additional', 'affiliation': []}, {'given': 'Peter', 'family': 'Dreger', 'sequence': 'additional', 'affiliation': []}, {'given': 'Katharina', 'family': 'Kriegsmann', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0003-2215-2059', 'authenticated-orcid': False, 'given': 'Richard F.', 'family': 'Schlenk', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-7166-5232', 'authenticated-orcid': False, 'given': 'Carsten', 'family': 'Müller-Tidow', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2022, 12, 29]]}, 'reference': [ { 'key': '503_CR1', 'doi-asserted-by': 'publisher', 'first-page': '2881', 'DOI': '10.1182/blood.2020008824', 'volume': '136', 'author': 'A Vijenthira', 'year': '2020', 'unstructured': 'Vijenthira, A. et al. 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