University Hospitals Leuven (UZ Leuven), Leuven, Belgium.
Catholic University of Leuven (KU Leuven), Leuven, Belgium.
Trials. 2020 Nov 27;21(1):981. doi: 10.1186/s13063-020-04876-0.
The COVID-19 pandemic has imposed an enormous burden on health care systems around the world. In the past, the administration of convalescent plasma of patients having recovered from SARS and severe influenza to patients actively having the disease showed promising effects on mortality and appeared safe. Whether or not this also holds true for the novel SARS-CoV-2 virus is currently unknown.
DAWn-Plasma is a multicentre nation-wide, randomized, open-label, phase II proof-of-concept clinical trial, evaluating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19 in Belgium. Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72 h before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chest-CT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis. Patients are randomized in a 2:1 ratio to either standard of care and convalescent plasma (active treatment group) or standard of care only. The active treatment group receives 2 units of 200 to 250 mL of convalescent plasma within 12 h after randomization, with a second administration of 2 units 24 to 36 h after ending the first administration. The trial aims to include 483 patients and will recruit from 25 centres across Belgium. The primary endpoint is the proportion of patients that require mechanical ventilation or have died at day 15. The main secondary endpoints are clinical status on day 15 and day 30 after randomization, as defined by the WHO Progression 10-point ordinal scale, and safety of the administration of convalescent plasma.
This trial will either provide support or discourage the use of convalescent plasma as an early intervention for the treatment of hospitalized patients with COVID-19 infection.
ClinicalTrials.gov NCT04429854 . Registered on 12 June 2020 - Retrospectively registered.
COVID-19 大流行给全世界的医疗系统带来了巨大的负担。过去，给患有 SARS 和严重流感并已康复的患者输注恢复期血浆，对降低死亡率有显著效果，且看起来是安全的。对于新型 SARS-CoV-2 病毒，这种方法是否同样有效目前尚不清楚。
DAWn-Plasma 是一项多中心、全国性、随机、开放性、二期概念验证临床试验，评估了在比利时因 COVID-19 住院的患者中，将恢复期血浆联合标准治疗与单独标准治疗相比的临床疗效和安全性。符合以下条件的患者有资格入组：有症状（即临床或影像学表现），且在入组前 72 小时内通过 PCR（鼻/鼻咽拭子或支气管肺泡灌洗）或胸部 CT 扫描确诊 COVID-19，胸部 CT 扫描显示 COVID-19 特征，且无其他诊断。患者以 2:1 的比例随机分为标准治疗和恢复期血浆组（治疗组）或仅标准治疗组。治疗组在随机分组后 12 小时内输注 2 单位 200-250ml 的恢复期血浆，第一次输注结束后 24-36 小时再输注 2 单位。试验的目标入组患者数为 483 例，将从比利时 25 个中心招募患者。主要终点是第 15 天需要机械通气或死亡的患者比例。主要次要终点是随机分组后第 15 天和第 30 天的临床状况，采用 WHO 10 级进展量表定义，以及恢复期血浆输注的安全性。
本试验将为恢复期血浆作为 COVID-19 感染住院患者的早期干预手段的应用提供支持或反对依据。
ClinicalTrials.gov NCT04429854。于 2020 年 6 月 12 日注册-回顾性注册。
