A phase 2 single center open label randomised control trial for convalescent plasma therapy in patients with severe COVID-19

{ 'indexed': {'date-parts': [[2024, 8, 6]], 'date-time': '2024-08-06T20:13:24Z', 'timestamp': 1722975204267}, 'reference-count': 46, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2022, 1, 19]], 'date-time': '2022-01-19T00:00:00Z', 'timestamp': 1642550400000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2022, 1, 19]], 'date-time': '2022-01-19T00:00:00Z', 'timestamp': 1642550400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [ { 'DOI': '10.13039/501100001412', 'name': 'Council of Scientific and Industrial Research', 'doi-asserted-by': 'publisher', 'award': ['MLP129'], 'id': [{'id': '10.13039/501100001412', 'id-type': 'DOI', 'asserted-by': 'publisher'}]}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'abstract': '<jats:title>Abstract</jats:title><jats:p>A single center open label phase 2 randomised ' 'control trial (Clinical Trial Registry of India No. CTRI/2020/05/025209) was done to assess ' 'clinical and immunological benefits of passive immunization using convalescent plasma ' 'therapy. At the Infectious Diseases and Beleghata General Hospital in Kolkata, India, 80 ' 'patients hospitalized with severe COVID-19 disease and fulfilling the inclusion criteria ' '(aged more than 18 years, with either mild ARDS having PaO2/FiO2 200–300 or moderate ARDS ' 'having PaO2/FiO2 100–200, not on mechanical ventilation) were recruited and randomized into ' 'either standard of care (SOC) arm (<jats:italic>N</jats:italic>\u2009=\u200940) or the ' 'convalescent plasma therapy (CPT) arm (<jats:italic>N</jats:italic>\u2009=\u200940). Primary ' 'outcomes were all-cause mortality by day 30 of enrolment and immunological correlates of ' 'response to therapy if any, for which plasma abundance of a large panel of cytokines was ' 'quantitated before and after intervention to assess the effect of CPT on the systemic ' 'hyper-inflammation encountered in these patients. The secondary outcomes were recovery from ' 'ARDS and time taken to negative viral RNA PCR as well as to report any adverse reaction to ' 'plasma therapy. Transfused convalescent plasma was characterized in terms of its neutralizing ' 'antibody content as well as proteome. The trial was completed and it was found that primary ' 'outcome of all-cause mortality was not significantly different among severe COVID-19 patients ' 'with ARDS randomized to two treatment arms (Mantel-Haenszel Hazard Ratio 0.6731, 95% ' 'confidence interval 0.3010-1.505, with a P value of 0.3424 on Mantel-Cox Log-rank test). No ' 'adverse effect was reported with CPT. In severe COVID-19 patients with mild or moderate ARDS ' 'no significant clinical benefit was registered in this clinical trial with convalescent ' 'plasma therapy in terms of prespecified outcomes.</jats:p>', 'DOI': '10.1038/s41467-022-28064-7', 'type': 'journal-article', 'created': {'date-parts': [[2022, 1, 19]], 'date-time': '2022-01-19T11:02:56Z', 'timestamp': 1642590176000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 34, 'title': 'A phase 2 single center open label randomised control trial for convalescent plasma therapy in ' 'patients with severe COVID-19', 'prefix': '10.1038', 'volume': '13', 'author': [ {'given': 'Yogiraj', 'family': 'Ray', 'sequence': 'first', 'affiliation': []}, {'given': 'Shekhar Ranjan', 'family': 'Paul', 'sequence': 'additional', 'affiliation': []}, {'given': 'Purbita', 'family': 'Bandopadhyay', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ranit', 'family': 'D’Rozario', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jafar', 'family': 'Sarif', 'sequence': 'additional', 'affiliation': []}, {'given': 'Deblina', 'family': 'Raychaudhuri', 'sequence': 'additional', 'affiliation': []}, {'given': 'Debaleena', 'family': 'Bhowmik', 'sequence': 'additional', 'affiliation': []}, {'given': 'Abhishake', 'family': 'Lahiri', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Janani Srinivasa', 'family': 'Vasudevan', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-0306-8970', 'authenticated-orcid': False, 'given': 'Ranjeet', 'family': 'Maurya', 'sequence': 'additional', 'affiliation': []}, {'given': 'Akshay', 'family': 'Kanakan', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sachin', 'family': 'Sharma', 'sequence': 'additional', 'affiliation': []}, {'given': 'Manish', 'family': 'Kumar', 'sequence': 'additional', 'affiliation': []}, {'given': 'Praveen', 'family': 'Singh', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-7273-4132', 'authenticated-orcid': False, 'given': 'Rammohan', 'family': 'Roy', 'sequence': 'additional', 'affiliation': []}, {'given': 'Kausik', 'family': 'Chaudhury', 'sequence': 'additional', 'affiliation': []}, {'given': 'Rajsekhar', 'family': 'Maiti', 'sequence': 'additional', 'affiliation': []}, {'given': 'Saugata', 'family': 'Bagchi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ayan', 'family': 'Maiti', 'sequence': 'additional', 'affiliation': []}, {'given': 'Md. 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