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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,250
Participants receive metformin tablets for a period of 12-weeks.
Participants receive colchicine tablets for a period of 12-weeks.
Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, Netherlands
Utrecht, Netherlands
Physical health-related quality of life (HRQoL)
PROMIS-29 physical health summary score
Time frame: 12 weeks
Mental HRQoL
PROMIS-29 mental health summary score
Time frame: 12 weeks
Other aspects of HRQoL
PROMIS-29 domain scores: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, sleep disturbance.
Time frame: 12 weeks
Fatigue
Checklist Individual Strength, fatigue severity subscale (CIS-8)
Time frame: 12 weeks
Post Exertional Malaise (PEM)
DePaul Symptom Questionnaire (DSQ-2) PEM questions
Time frame: 12 weeks
Cognitive functioning
PROMIS cognitive function 8a
Time frame: 12 weeks
Post Orthostatic Tachycardia Syndrome (POTS)
DSQ-2 POTS questions
Time frame: 12 weeks
Safety of IPs
Frequency of related and unrelated (S)AEs and SUSARs in each IP arm including their severity and outcome.
Time frame: 12 weeks
Tolerability of IPs
Level of adherence to each IP. Percent of participants with adequate adherence for the specific IP.
Time frame: 12 weeks
Durability of IP treatment responses
The proportion of participants that maintain HRQoL treatment success at 24 weeks.
Time frame: 24 weeks
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