A randomized placebo-controlled trial of convalescent plasma for adults hospitalized with COVID-19 pneumonia

{ 'indexed': {'date-parts': [[2022, 10, 1]], 'date-time': '2022-10-01T05:16:49Z', 'timestamp': 1664601409930}, 'reference-count': 18, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2022, 9, 30]], 'date-time': '2022-09-30T00:00:00Z', 'timestamp': 1664496000000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2022, 9, 30]], 'date-time': '2022-09-30T00:00:00Z', 'timestamp': 1664496000000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [{'DOI': '10.13039/501100003554', 'name': 'Lundbeckfonden', 'doi-asserted-by': 'publisher'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'abstract': '<jats:title>Abstract</jats:title><jats:p>Passive immunotherapy with convalescent plasma may ' 'be the only available agent during the early phases of a pandemic. Here, we report safety and ' 'efficacy of high-titer convalescent plasma for COVID-19 pneumonia. Double-blinded randomized ' 'multicenter placebo-controlled trial of adult patients hospitalized with COVID-19 pneumonia. ' 'The intervention was COVID-19 convalescent plasma and placebo was saline allocated 2:1. The ' 'primary outcome was clinical status 14\xa0days after the intervention evaluated on a clinical ' 'ordinal scale. The trial was registered at ClinicalTrials.Gov, NCT04345289, 14/04/2020. The ' 'CCAP-2 trial was terminated prematurely due to futility. Of 147 patients randomized, we ' 'included 144 patients in the modified intention-to-treat population. The ordinal clinical ' 'status 14\xa0days post-intervention was comparable between treatment groups (odds ratio (OR) ' '1.41, 95% confidence interval (CI) 0.72–2.09). Results were consistent when evaluating ' 'clinical progression on an individual level 14\xa0days after intervention (OR 1.09; 95% CI ' '0.46–1.73). No significant differences in length of hospital stay, admission to ICU, ' 'frequency of severe adverse events or all-cause mortality during follow-up were found between ' 'the intervention and the placebo group. Infusion of convalescent plasma did not influence ' 'clinical progression, survival or length of hospitalization in patients with COVID-19 ' 'pneumonia.</jats:p>', 'DOI': '10.1038/s41598-022-19629-z', 'type': 'journal-article', 'created': {'date-parts': [[2022, 9, 30]], 'date-time': '2022-09-30T11:15:12Z', 'timestamp': 1664536512000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'A randomized placebo-controlled trial of convalescent plasma for adults hospitalized with ' 'COVID-19 pneumonia', 'prefix': '10.1038', 'volume': '12', 'author': [ {'given': 'Louise', 'family': 'Thorlacius-Ussing', 'sequence': 'first', 'affiliation': []}, {'given': 'Patrick Terrence', 'family': 'Brooks', 'sequence': 'additional', 'affiliation': []}, {'given': 'Henrik', 'family': 'Nielsen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Bitten Aagaard', 'family': 'Jensen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Lothar', 'family': 'Wiese', 'sequence': 'additional', 'affiliation': []}, {'given': 'Susanne Gjørup', 'family': 'Sækmose', 'sequence': 'additional', 'affiliation': []}, {'given': 'Stine', 'family': 'Johnsen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mikkel', 'family': 'Gybel-Brask', 'sequence': 'additional', 'affiliation': []}, {'given': 'Isik S.', 'family': 'Johansen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mie Topholm', 'family': 'Bruun', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nina Breinholdt', 'family': 'Stærke', 'sequence': 'additional', 'affiliation': []}, {'given': 'Lars', 'family': 'Østergaard', 'sequence': 'additional', 'affiliation': []}, {'given': 'Christian', 'family': 'Erikstrup', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sisse Rye', 'family': 'Ostrowski', 'sequence': 'additional', 'affiliation': []}, {'given': 'Keld Mikkelsen', 'family': 'Homburg', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jørgen', 'family': 'Georgsen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Susan', 'family': 'Mikkelsen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Håkon', 'family': 'Sandholdt', 'sequence': 'additional', 'affiliation': []}, {'given': 'Cæcilie', 'family': 'Leding', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nichlas', 'family': 'Hovmand', 'sequence': 'additional', 'affiliation': []}, {'given': 'Clara Lundetoft', 'family': 'Clausen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Michaela', 'family': 'Tinggaard', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Karen Brorup Heje', 'family': 'Pedersen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Katrine Kjær', 'family': 'Iversen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sandra', 'family': 'Tingsgård', 'sequence': 'additional', 'affiliation': []}, {'given': 'Simone Bastrup', 'family': 'Israelsen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Thomas', 'family': 'Benfield', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2022, 9, 30]]}, 'reference': [ { 'issue': '8', 'key': '19629_CR1', 'doi-asserted-by': 'publisher', 'first-page': '599', 'DOI': '10.7326/0003-4819-145-8-200610170-00139', 'volume': '145', 'author': 'TC Luke', 'year': '2006', 'unstructured': 'Luke, T. 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Dr Østergaard reports personal fees ' 'from Sanofi. Dr Erikstrup reports grants from Abbots diagnostic outside of the ' 'submitted work. Dr Benfield reports grants from Novo Nordisk Foundation, grants ' 'from Simonsen Foundation, grants and personal fees from GSK, grants and ' 'personal fees from Pfizer, personal fees from Boehringer Ingelheim, personal ' 'fees from Abbvie, grants and personal fees from Gilead, personal fees from MSD, ' 'grants from Lundbeck Foundation, grants from Kai Hansen Foundation, and grants ' 'from Erik and Susanna Olsen’s Charitable Fund outside the submitted work. All ' 'other authors have nothing to disclose.', 'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '16385'}