Centre d'Investigation Clinique Inserm CIC1431, CHU Besançon, Besançon, Bourgogne Franche-Comté, France
UMR 1098 Right, Inserm, Établissement Français du Sang, Université de Franche-Comté, Besançon, Bourgogne Franche-Comté, France.
BMJ Open. 2023 Apr 27;13(4):e071277. doi: 10.1136/bmjopen-2022-071277.
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.
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.
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.
Clinical Trials.gov (NCT05271929), EudraCT (2021-006621-22).
COVID-19 恢复期血浆（CCP）是 COVID-19 的一种可能治疗选择。已经进行了大量关于 CCP 疗效的临床试验。然而，CCP 治疗的许多方面仍需要进一步研究：特别是（1）优化 CCP 产品，（2）确定需要这种治疗方法且最有可能从中受益的患者人群，（3）给药时间，以及（4）体内不同病毒变体的 CCP 疗效。我们旨在测试早期给予高滴度 CCP 是否可有效预防高危患者住院或死亡。
COVIC-19 是一项多中心、随机、开放标签、适应性优效性 III 期试验，比较了在症状出现后 7 天内给予高中和抗体滴度的 CCP 联合标准治疗与单独标准治疗。我们将招募两个脆弱患者队列的患者 [(1) 70 岁以上的老年人，或患有合并症的年轻患者；(2) 免疫功能低下的患者]。每个队列将招募多达 1020 名参与者（至少在达到 102 名参与者后进行样本量重新估计）。主要终点是（1）因 COVID-19 进展而住院，或（2）随机分组后第 28 天死亡的参与者比例。主要分析将遵循意向治疗原则。
乌尔姆大学伦理委员会（#41/22）（德国主要伦理委员会）、南东部 I 保护委员会（CPP Sud-Est I）（#2022-A01307-36）（法国伦理委员会）和伊拉斯姆斯医学中心伦理委员会（#MEC-2022-0365）（荷兰伦理委员会）已批准伦理。所有纳入的患者都将获得书面知情同意。研究结果将发表在同行评议的期刊上，并在相关利益相关者会议和会议上展示。
ClinicalTrials.gov（NCT05271929），EudraCT（2021-006621-22）。
