TY - JOUR
T1 - Early, very high-titre convalescent plasma therapy in clinically vulnerable individuals with mild COVID-19 (COVIC-19)
T2 - protocol for a randomised, open-label trial
AU - Desmarets, Maxime
AU - Hoffmann, Simone
AU - Vauchy, Charline
AU - Rijnders, Bart J. A.
AU - Toussirot, Eric
AU - Durrbach, Antoine
AU - Körper, Sixten
AU - Schrezenmeier, Eva
AU - van der Schoot, C. Ellen
AU - Harvala, Heli
AU - Brunotte, Gaëlle
AU - Appl, Thomas
AU - Seifried, Erhard
AU - Tiberghien, Pierre
AU - Bradshaw, Daniel
AU - Roberts, David J.
AU - Estcourt, Lise J.
AU - Schrezenmeier, Hubert
N1 - Funding Information: This work is supported by the Support-e project, a project funded by the European Union’s Horizon 2020 research and innovation programme (grant number 101015756, www.support-e.eu ), the German Bundesministerium für Bildung und Forschung (BMBF, Projektträger VDE/VDI grant number 16LW0108), and ZonMw, the Netherlands Organisation for Health Research and Development (grant number 10430062010001). The funding sources had no role in the design of the study and will not have any role during its conduct, analysis, interpretation of findings or decision to submit results. Publisher Copyright: © 2023 BMJ Publishing Group. All rights reserved.
PY - 2023/4/27
Y1 - 2023/4/27
N2 - Introduction COVID-19 convalescent plasma (CCP) is a possible treatment option for COVID-19. A comprehensive number of clinical trials on CCP efficacy have already been conducted. However, many aspects of CCP treatment still require investigations: in particular (1) Optimisation of the CCP product, (2) Identification of the patient population in need and most likely to benefit from this treatment approach, (3) Timing of administration and (4) CCP efficacy across viral variants in vivo. We aimed to test whether high-titre CCP, administered early, is efficacious in preventing hospitalisation or death in high-risk patients. Methods and analysis COVIC-19 is a multicentre, randomised, open-label, adaptive superiority phase III trial comparing CCP with very high neutralising antibody titre administered within 7 days of symptom onset plus standard of care versus standard of care alone. We will enrol patients in two cohorts of vulnerable patients [(1) elderly 70+ years, or younger with comorbidities; (2) immunocompromised patients]. Up to 1020 participants will be enrolled in each cohort (at least 340 with a sample size re-estimation after reaching 102 patients). The primary endpoint is the proportion of participants with (1) Hospitalisation due to progressive COVID-19, or (2) Who died by day 28 after randomisation. Principal analysis will follow the intention-to-treat principle. Ethics and dissemination Ethical approval has been granted by the University of Ulm ethics committee (#41/22) (lead ethics committee for Germany), Comité de protection des personnes Sud-Est I (CPP Sud-Est I) (#2022-A01307-36) (ethics committee for France), and ErasmusMC ethics committee (#MEC-2022-0365) (ethics committee for the Netherlands). Signed informed consent will be obtained from all included patients. The findings will be published in peer-reviewed journals and presented at relevant stakeholder conferences and meetings. Trial registration Clinical Trials.gov
AB - Introduction COVID-19 convalescent plasma (CCP) is a possible treatment option for COVID-19. A comprehensive number of clinical trials on CCP efficacy have already been conducted. However, many aspects of CCP treatment still require investigations: in particular (1) Optimisation of the CCP product, (2) Identification of the patient population in need and most likely to benefit from this treatment approach, (3) Timing of administration and (4) CCP efficacy across viral variants in vivo. We aimed to test whether high-titre CCP, administered early, is efficacious in preventing hospitalisation or death in high-risk patients. Methods and analysis COVIC-19 is a multicentre, randomised, open-label, adaptive superiority phase III trial comparing CCP with very high neutralising antibody titre administered within 7 days of symptom onset plus standard of care versus standard of care alone. We will enrol patients in two cohorts of vulnerable patients [(1) elderly 70+ years, or younger with comorbidities; (2) immunocompromised patients]. Up to 1020 participants will be enrolled in each cohort (at least 340 with a sample size re-estimation after reaching 102 patients). The primary endpoint is the proportion of participants with (1) Hospitalisation due to progressive COVID-19, or (2) Who died by day 28 after randomisation. Principal analysis will follow the intention-to-treat principle. Ethics and dissemination Ethical approval has been granted by the University of Ulm ethics committee (#41/22) (lead ethics committee for Germany), Comité de protection des personnes Sud-Est I (CPP Sud-Est I) (#2022-A01307-36) (ethics committee for France), and ErasmusMC ethics committee (#MEC-2022-0365) (ethics committee for the Netherlands). Signed informed consent will be obtained from all included patients. The findings will be published in peer-reviewed journals and presented at relevant stakeholder conferences and meetings. Trial registration Clinical Trials.gov
KW - Blood bank & transfusion medicine
KW - COVID-19
KW - Clinical trials
KW - INFECTIOUS DISEASES
KW - Respiratory infections
UR - http://www.scopus.com/inward/record.url?scp=85158851358&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2022-071277
DO - https://doi.org/10.1136/bmjopen-2022-071277
M3 - Article
C2 - 37105693
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e071277
ER -