Journal article
Early, very high-titre convalescent plasma therapy in clinically vulnerable individuals with mild COVID-19 (COVIC-19): protocol for a randomised, open-label trial
- Abstract:
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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 (NCT05271929), EudraCT (2021-006621-22)
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 8.1MB, Terms of use)
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- Publisher copy:
- 10.1136/bmjopen-2022-071277
Authors
- Funder identifier:
- https://ror.org/04pz7b180
- Grant:
- 16LW0108
- Programme:
- Projektträger VDE/VDI
- Funder identifier:
- https://ror.org/00k4n6c32
- Grant:
- 101015756
- Publisher:
- BMJ Publishing
- Journal:
- BMJ Open More from this journal
- Volume:
- 13
- Issue:
- 4
- Article number:
- e071277
- Publication date:
- 2023-04-27
- Acceptance date:
- 2023-02-24
- DOI:
- EISSN:
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2044-6055
- ISSN:
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2044-6055
- Pmid:
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37105693
- Language:
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English
- Keywords:
- Pubs id:
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1343522
- Local pid:
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pubs:1343522
- Deposit date:
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2023-08-16
- ARK identifier:
Terms of use
- Copyright holder:
- Desmarets et al.
- Copyright date:
- 2023
- Rights statement:
- © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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