RECLAIM: an Adaptive Platform Trial for the Evaluation of Treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,250
- 试验地点
- 1
- 主要终点
- Physical health-related quality of life (HRQoL)
研究概览
简要总结
RECLAIM is a Phase III, multi-domain, randomized, controlled, adaptive platform trial, designed to evaluate efficacy and safety of repurposed medications in patients with post-COVID condition (PCC). The trial started in the Netherlands in February 2025, comparing metformin, colchicine and usual care in an open-label domain. The information in this registration concerns that first domain in the Netherlands. A second domain, comparing minocyclin to a matching placebo, is expected to start in January 2026, also in the Netherlands. Trial-arms, additional domains and implementing countries may be introduced or terminated as the trial progresses. Participation is fully remote, using electronic consenting, video consultations and home delivery of medication. Default IP use is 12 weeks with biweekly online follow-up questionnaires between Day-1 and Week-12, and one final follow-up questionnaire at week-24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The first domain is open label. The second domain (minocyclin versus placebo) will be placebo-controlled and blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Metformin
干预措施: Metformin (Drug)
Colchicine
干预措施: colchicine (Drug)
结局指标
主要结局
Physical health-related quality of life (HRQoL)
时间窗: 12 weeks
PROMIS-29 physical health summary score
次要结局
- Mental HRQoL(12 weeks)
- Other aspects of HRQoL(12 weeks)
- Fatigue(12 weeks)
- Post Exertional Malaise (PEM)(12 weeks)
- Cognitive functioning(12 weeks)
- Post Orthostatic Tachycardia Syndrome (POTS)(12 weeks)
- Safety of IPs(12 weeks)
- Tolerability of IPs(12 weeks)
- Durability of IP treatment responses(24 weeks)
研究者
Janneke van de Wijgert
Professor
UMC Utrecht