RECLAIM Adaptive Platform Trial for PCC Treatments
NCT07280572 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1250
Last updated 2025-12-12
Summary
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.
Conditions
- Post COVID Condition
Interventions
- DRUG
-
Participants receive metformin tablets for a period of 12-weeks.
- DRUG
-
colchicine
Participants receive colchicine tablets for a period of 12-weeks.
Sponsors & Collaborators
-
European Clinical Research Alliance for Infectious Diseases (ECRAID)
collaborator OTHER -
Janneke van de Wijgert
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-17
- Primary Completion
- 2027-12-01
- Completion
- 2027-12-01
Countries
- Netherlands
Study Locations
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