Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial
department or school: Medicine, Faculty of
department or school: Non UBC
department or school: Pathology and Laboratory Medicine, Department of
data provider: DSpace
identifier citation: Trials. 2021 May 04;22(1):323
rights copyright: The Author(s)
creator: Bégin, Philippe
creator: Callum, Jeannie
creator: Heddle, Nancy M.
creator: Cook, Richard
creator: Zeller, Michelle P.
creator: Tinmouth, Alan
creator: Fergusson, Dean A.
creator: Cushing, Melissa M.
creator: Glesby, Marshall J.
creator: Chassé, Michaël
creator: Devine, Dana V.
creator: Robitalle, Nancy
creator: Bazin, Renée
creator: Shehata, Nadine
creator: Finzi, Andrés
creator: McGeer, Allison
creator: Scales, Damon C.
creator: Schwartz, Lisa
creator: Turgeon, Alexis F.
creator: Zarychanski, Ryan
creator: Daneman, Nick
creator: Carl, Richard
creator: Amorim, Luiz
creator: Gabe, Caroline
creator: Ellis, Martin
creator: Sachais, Bruce S.
creator: Loftsgard, Kent C.
creator: Jamula, Erin
creator: Carruthers, Julie
creator: Duncan, Joanne
creator: Lucier, Kayla
creator: Li, Na
creator: Liu, Yang
creator: Armali, Chantal
creator: Kron, Amie
creator: Modi, Dimpy
creator: Auclair, Marie-Christine
creator: Cerro, Sabrina
creator: Avram, Meda
creator: Arnold, Donald M.
issued: 2021-05-05T18:12:01Z
issued: 2021-05-04
description: Background: Convalescent plasma has been used for numerous viral diseases including influenza, severe acute respiratory syndrome, Middle East respiratory syndrome and Ebola virus; however, evidence to support its use is weak. SARS-CoV-2 is a novel coronavirus responsible for the 2019 global pandemic of COVID-19 community acquired pneumonia. We have undertaken a randomized controlled trial to assess the efficacy and safety of COVID-19 convalescent plasma (CCP) in patients with SARS-CoV-2 infection. Methods: CONCOR-1 is an open-label, multicentre, randomized trial. Inclusion criteria include the following: patients > 16 years, admitted to hospital with COVID-19 infection, receiving supplemental oxygen for respiratory complications of COVID-19, and availability of blood group compatible CCP. Exclusion criteria are : onset of respiratory symptoms more than 12 days prior to randomization, intubated or imminent plan for intubation, and previous severe reactions to plasma. Consenting patients are randomized 2:1 to receive either approximately 500 mL of CCP or standard of care. CCP is collected from donors who have recovered from COVID-19 and who have detectable anti-SARS-CoV-2 antibodies quantified serologically. The primary outcome is intubation or death at day 30. Secondary outcomes include ventilator-free days, length of stay in intensive care or hospital, transfusion reactions, serious adverse events, and reduction in SARS-CoV-2 viral load. Exploratory analyses include patients who received CCP containing high titre antibodies. A sample size of 1200 patients gives 80% power to detect a 25% relative risk reduction assuming a 30% baseline risk of intubation or death at 30 days (two-sided test; α = 0.05). An interim analysis and sample size re-estimation will be done by an unblinded independent biostatistician after primary outcome data are available for 50% of the target recruitment (n = 600). Discussion: This trial will determine whether CCP will reduce intubation or de…
aggregated CHO: https://circle.library.ubc.ca/rest/handle/2429/78109
note: STUDY PROTOCOL Open AccessConvalescent plasma for adults with acuteCOVID-19 respiratory illness (CONCOR-1):study protocol for an international,multicentre, randomized, open-label trialPhilippe Bégin1,2, Jeannie Callum3,4, Nancy M. Heddle5,6, Richard Cook7, Michelle P. Zeller5,6,10, Alan Tinmouth8,9,10,Dean A. Fergusson11,12,13, Melissa M. Cushing14,15, Marshall J. Glesby16, Michaël Chassé17,18, Dana V. Devine10,19,Nancy Robitalle20,21, Renée Bazin22, Nadine Shehata23,24,25, Andrés Finzi26,27, Allison McGeer28,29,Damon C. Scales30,31, Lisa Schwartz32, Alexis F. Turgeon33,34, Ryan Zarychanski35, Nick Daneman36, Richard Carl5,6,Luiz Amorim37, Caroline Gabe6, Martin Ellis38,39, Bruce S. Sachais15,40, Kent Cadogan Loftsgard6, Erin Jamula6,Julie Carruthers6, Joanne Duncan6, Kayla Lucier6, Na Li6,41,42, Yang Liu6, Chantal Armali3, Amie Kron3, Dimpy Modi3,Marie-Christine Auclair43, Sabrina Cerro43, Meda Avram43 and Donald M. Arnold5,6*AbstractBackground: Convalescent plasma has been used for numerous viral diseases including influenza, severe acuterespiratory syndrome, Middle East respiratory syndrome and Ebola virus; however, evidence to support its use isweak. SARS-CoV-2 is a novel coronavirus responsible for the 2019 global pandemic of COVID-19 communityacquired pneumonia. We have undertaken a randomized controlled trial to assess the efficacy and safety of COVID-19 convalescent plasma (CCP) in patients with SARS-CoV-2 infection.(Continued on next page)© The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you giveappropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate ifchanges were made. The images or other third party material in this article are included in the article's Creative Commonslicence, unless indicated otherwise in a credi…
has type: Article
is shown at: 10.14288/1.0397254
language: eng
peer review status: Reviewed
provider: Vancouver : University of British Columbia Library
publisher: BioMed Central
publisher DOI: 10.1186/s13063-021-05235-3
rights: Attribution 4.0 International (CC BY 4.0)
rights URI: http://creativecommons.org/licenses/by/4.0/
scholar level: Faculty
subject: Convalescent plasma
subject: SARS-CoV-2
subject: Coronavirus
subject: COVID-19
subject: Randomized controlled trial
type: Text
identifier URI: http://hdl.handle.net/2429/78109