Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial

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dc.contributor.authorBégin, Philippe
dc.contributor.authorCallum, Jeannie
dc.contributor.authorHeddle, Nancy M
dc.contributor.authorCook, Richard
dc.contributor.authorZeller, Michelle P
dc.contributor.authorTinmouth, Alan
dc.contributor.authorFergusson, Dean A
dc.contributor.authorCushing, Melissa M
dc.contributor.authorGlesby, Marshall J
dc.contributor.authorChassé, Michaël
dc.contributor.authorDevine, Dana V
dc.contributor.authorRobitalle, Nancy
dc.contributor.authorBazin, Renée
dc.contributor.authorShehata, Nadine
dc.contributor.authorFinzi, Andrés
dc.contributor.authorMcGeer, Allison
dc.contributor.authorScales, Damon C
dc.contributor.authorSchwartz, Lisa
dc.contributor.authorTurgeon, Alexis F
dc.contributor.authorZarychanski, Ryan
dc.contributor.authorDaneman, Nick
dc.contributor.authorCarl, Richard
dc.contributor.authorAmorim, Luiz
dc.contributor.authorGabe, Caroline
dc.contributor.authorEllis, Martin
dc.contributor.authorSachais, Bruce S
dc.contributor.authorLoftsgard, Kent C
dc.contributor.authorJamula, Erin
dc.contributor.authorCarruthers, Julie
dc.contributor.authorDuncan, Joanne
dc.contributor.authorLucier, Kayla
dc.contributor.authorLi, Na
dc.contributor.authorLiu, Yang
dc.contributor.authorArmali, Chantal
dc.contributor.authorKron, Amie
dc.contributor.authorModi, Dimpy
dc.contributor.authorAuclair, Marie-Christine
dc.contributor.authorCerro, Sabrina
dc.contributor.authorAvram, Meda
dc.contributor.authorArnold, Donald M
dc.date.accessioned2021-05-09T00:03:42Z
dc.date.available2021-05-09T00:03:42Z
dc.date.issued2021-05-04
dc.date.updated2021-05-09T00:03:41Z
dc.description.abstractAbstract 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 death non-intubated adults with COVID-19. The trial will also provide information on the role of and thresholds for SARS-CoV-2 antibody titres and neutralization assays for donor qualification. Trial registration Clinicaltrials.gov NCT04348656 . Registered on 16 April 2020.
dc.identifier.citationTrials. 2021 May 04;22(1):323
dc.identifier.doihttps://doi.org/10.1186/s13063-021-05235-3
dc.identifier.urihttp://hdl.handle.net/1880/113387
dc.identifier.urihttps://doi.org/10.11575/PRISM/44747
dc.language.rfc3066en
dc.rights.holderThe Author(s)
dc.titleConvalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial
dc.typeJournal Article
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