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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Bégin Philippe, Callum Jeannie, Heddle Nancy M, Cook Richard, Zeller Michelle P, Tinmouth Alan, Fergusson Dean A, Cushing Melissa M, Glesby Marshall J, Chassé Michaël, Devine Dana V, Robitalle Nancy, Bazin Renée, Shehata Nadine, Finzi Andrés, McGeer Allison, Scales Damon C, Schwartz Lisa, Turgeon Alexis F, Zarychanski Ryan, Daneman Nick, Carl Richard, Amorim Luiz, Gabe Caroline, Ellis Martin, Sachais Bruce S, Loftsgard Kent Cadogan, Jamula Erin, Carruthers Julie, Duncan Joanne, Lucier Kayla, Li Na, Liu Yang, Armali Chantal, Kron Amie, Modi Dimpy, Auclair Marie-Christine, Cerro Sabrina, Avram Meda, Arnold Donald M
Аннотация
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.