About: Mortality reduction in 46 severe Covid-19 patients treated with hyperimmune plasma. A proof of concept single arm multicenter interventional trial

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About: Mortality reduction in 46 severe Covid-19 patients treated with hyperimmune plasma. A proof of concept single arm multicenter interventional trial Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Mortality reduction in 46 severe Covid-19 patients treated with hyperimmune plasma. A proof of concept single arm multicenter interventional trial
Creator	Baldanti, Fausto Percivalle, Elena Meloni, Federica Belliato, Mirko Bruno, Raffaele Franchini, Massimo Seminari, Elena Casari, Salvatore De Donno, Giuseppe Fante, Claudia Garuti, Martina Glingani, Claudia Klersy, Catherine Musella, Valeria Perotti, Cesare Frigato, Marilena Sabatino, Antonio
Source	MedRxiv
abstract	BACKGROUND Hyperimmune plasma from Covid-19 convalescent is a potential treatment for severe Covid-19. METHODS We conducted a multicenter one arm proof of concept interventional study. Patients with Covid-19 disease with moderate-to-severe Acute Respiratory Distress Syndrome, elevated C-reactive Protein and need for mechanical ventilation and/or CPAP were enrolled. One to three 250-300 ml unit of hyperimmune plasma (neutralizing antibodies titer [≥]1:160) were administered. Primary outcome was 7-days hospital mortality. Secondary outcomes were PaO2/FiO2, laboratory and radiologic changes, as well as weaning from mechanical ventilation and safety. RESULTS The study observed 46 patients from March, 25 to April, 21 2020. Patients were aged 63, 61% male, 30 on CPAP and 7 intubated. PaO2/FiO2 was 128 (SD 47). Symptoms and ARDS duration were 14 (SD 7) and 6 days (SD 3). Three patients (6.5%) died within 7 days. The upper one-sided 90%CI was 13.9%, allowing to reject the null hypothesis of a 15% mortality. PaO2/FiO2 increased by 112 units (95%CI 82 to142) in survivors, the chest radiogram severity decreased in 23% (95%CI 5% to 42%); CRP, Ferritin and LDH decreased by 60, 36 and 20% respectively. Weaning from CPAP was obtained in 26/30 patients and 3/7 were extubated. Five serious adverse events occurred in 4 patients (2 likely, 2 possible treatment related). CONCLUSIONS Hyperimmune plasma in Covid-19 shows promising benefits, to be confirmed in a randomized controlled trial. This proof of concept study could open to future developments including hyperimmune plasma banking, development of standardized pharmaceutical products and monoclonal antibodies.
has issue date	2020-05-29(xsd:dateTime)
bibo:doi	10.1101/2020.05.26.20113373
has license	medrxiv
sha1sum (hex)	451ec1ead88288c6241c8dc29ad999e5657df2d4
schema:url	https://doi.org/10.1101/2020.05.26.20113373
resource representing a document's title	Mortality reduction in 46 severe Covid-19 patients treated with hyperimmune plasma. A proof of concept single arm multicenter interventional trial
resource representing a document's body	covid:451ec1ead88288c6241c8dc29ad999e5657df2d4#body_text
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