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Enrolling By InvitationNCT07280572

RECLAIM Adaptive Platform Trial for PCC Treatments

RECLAIM: an Adaptive Platform Trial for the Evaluation of Treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Status
Enrolling By Invitation
Phase
Phase 3
Study type
Interventional
Enrollment
1,250 (estimated)
Sponsor
Janneke van de Wijgert · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGMetforminParticipants receive metformin tablets for a period of 12-weeks.
DRUGcolchicineParticipants receive colchicine tablets for a period of 12-weeks.

Timeline

Start date
2025-02-17
Primary completion
2027-12-01
Completion
2027-12-01
First posted
2025-12-12
Last updated
2025-12-12

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT07280572. Inclusion in this directory is not an endorsement.