RECLAIM Adaptive Platform Trial for PCC Treatments
Netherlands1,250 participantsStarted 2025-02-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Adults aged 18 years or older.
ā. Residing in the Netherlands (but excluding the Carribbean parts of the Netherlands) for the duration of trial participation.
ā. Persistent PCC symptoms, including fatigue and/or PEM, for a period of at least 12 weeks after the onset of a SARS-CoV-2 infection. The symptoms were not present prior to the infection, but may have partially subsided and resurged after the infection.
ā. Self-reported confirmation of having had a SARS-CoV-2 infection by:
ā. Positive SARS-CoV-2 nucleic acid amplification test, such as PCR;
ā. Positive SARS-CoV-2 rapid diagnostic test, including home-administered tests;
ā. COVID-19 diagnosis by a medical specialist (GP or in-hospital), based on the above or other clinical tests and assessments.
ā. Willing and able to provide informed consent.
Exclusion criteria
ā. Having been diagnosed with (exacerbation of) a chronic disease that can account for the onset of the PCC-like symptoms.
ā. Being hospitalized or institutionalized at screening. Patients can be rescreened after discharge.
ā. Presence of a serious medical condition that would prevent completion of follow-up.
ā. Currently enrolled, or having been enrolled within the last 30 days, in any other study where that study's interventions or procedures may affect RECLAIM outcomes or procedures. Individuals can be rescreened after at least 30 days have passed since participation in such a study has been completed.
ā. The participant cannot be randomized to at least one IP arm and its control arm within a trial domain due to:
ā. Known hypersensitivity to an active IP ingredient or IP/placebo excipient;
ā. Receiving a treatment that is contraindicated to a trial IP;
ā. Already using a trial IP, or a drug in the same drug class as a trial IP, outside of the trial;