背景:对于长期COVID,目前尚无有效的药物治疗,其特点是范围广,多系统,波动,或在大部分急性COVID幸存者中出现复发症状。这项随机对照试验旨在评估抗炎药秋水仙碱的安全性和有效性。以减轻那些有长期COVID风险的人的症状。
方法:这种多中心,平行臂,1:1个随机个体,安慰剂对照,双盲优势试验将招募350名患有持续性COVID后症状的个体。参与者将被随机分配给秋水仙碱0.5mg,每天一次(<70kg)或每天两次(≥70kg)或匹配的安慰剂,持续26周,并将在随机分组后随访至52周。主要试验目标是证明秋水仙碱优于安慰剂在从基线开始52周时6分钟内改善步行距离。次要目标是评估秋水仙碱与安慰剂相比在肺功能方面的疗效。炎症标志物,宪法症状,和心理健康状况。在100名参与者的子样本中,将使用MRI比较心肌损伤和心肌水肿的心脏生物标志物。
结论:SARS-CoV-19后持续的炎症反应是长期COVID的假定病理生理机制之一。秋水仙碱,一种低成本的抗炎药,通过多种炎症途径起作用,并具有既定的安全性。该试验将为重要的健康优先事项提供证据,可以迅速转化为实践。
背景:该临床试验已在www上进行了前瞻性注册。
结果:gov,注册CTRI/2021/11/038234,日期为2021年11月24日。
BACKGROUND: There is no known effective pharmacological therapy for long COVID, which is characterized by wide-ranging, multisystemic, fluctuating, or relapsing symptoms in a large proportion of survivors of acute COVID. This randomized controlled trial aims to assess the safety and efficacy of an anti-inflammatory agent
colchicine, to reduce symptoms among those at high risk of developing long COVID.
METHODS: This multi-centre, parallel arm, 1:1 individual randomized, placebo-controlled, double-blind superiority trial will enrol 350 individuals with persistent post-COVID symptoms. Participants will be randomized to either
colchicine 0.5 mg once daily (< 70 kg) or twice daily (≥ 70 kg) or matched placebo for 26 weeks and will be followed up until 52 weeks after randomization. The primary trial objective is to demonstrate the superiority of
colchicine over a placebo in improving distance walked in 6 min at 52 weeks from baseline. The secondary objectives are to assess the efficacy of
colchicine compared to placebo with respect to lung function, inflammatory markers, constitutional symptoms, and mental health state. In a sub-sample of 100 participants, cardiac biomarkers of myocardial injury and myocardial oedema using MRI will be compared.
CONCLUSIONS: Persistent inflammatory response following SARS-CoV-19 is one of the postulated pathophysiological mechanisms of long COVID.
Colchicine, a low-cost anti-inflammatory agent, acts via multiple inflammatory pathways and has an established safety profile. This trial will generate evidence for an important health priority that can rapidly translate into practice.
BACKGROUND: This clinical trial has been registered prospectively on www.
RESULTS: gov with registration CTRI/2021/11/038234 dated November 24, 2021.