Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials
Christina M EckhardtMax R O'Donnell

Abstract

The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection. This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor. Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic...Continue Reading

Associated Clinical Trials

Citations

Jul 11, 2020·The Cochrane Database of Systematic Reviews·Vanessa PiechottaNicole Skoetz
Jul 28, 2020·International Journal of Molecular Sciences·Alessandra FierabracciPaolo Rossi
Sep 10, 2020·International Journal of Molecular Sciences·Neelu BatraAi-Ming Yu
Oct 13, 2020·The Cochrane Database of Systematic Reviews·Khai Li ChaiNicole Skoetz
Dec 10, 2020·Nature Biomedical Engineering·Shibo JiangLanying Du
Dec 8, 2020·International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases·Sondas AlsharidahMedhat Z Askar
Jan 6, 2021·International Journal of Antimicrobial Agents·Charles S Pavia, Gary P Wormser
Dec 3, 2020·Risk Management and Healthcare Policy·Nandeeta SamadMainul Haque
Mar 5, 2021·Globalization and Health·Bisi BrightMorenike Oluwatoyin Folayan
Apr 8, 2021·JMIR Public Health and Surveillance·Henry T PengAndrew Beckett
May 21, 2021·The Cochrane Database of Systematic Reviews·Vanessa PiechottaNicole Skoetz
Jun 15, 2021·Vox Sanguinis·Marina IzakEilat Shinar
May 12, 2021·The Journal of Clinical Investigation·Max R O'DonnellWalter I Lipkin
Jul 13, 2021·Current Clinical Microbiology Reports·Rashed NoorChandrika Saha
Jul 6, 2021·Clinical Trials : Journal of the Society for Clinical Trials·Shing M LeeMagdalena Sobieszczyk
Jul 10, 2021·Thérapie·Shivshankar Malkarjun GunjegaonkarVelayutham Ravichandiran

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