RECLAIM Adaptive Platform Trial for PCC Treatments

NCT07280572 | Enrolling By Invitation Phase 3 DMC

• 2 other identifiers: EUCT 2024-511580-28D-25-500086
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Post COVID condition; Clinical trial; Intervention; Repurposed drugs; Metformin; Colchicine; PAIS; Post Acute Sequelae of COVID-19

Outcome Measures

Primary Outcomes (1)

• Physical health-related quality of life (HRQoL)

  PROMIS-29 physical health summary score

  12 weeks

Secondary Outcomes (9)

• Mental HRQoL

  12 weeks

• Other aspects of HRQoL

  12 weeks

• Fatigue

  12 weeks

• Post Exertional Malaise (PEM)

  12 weeks

• Cognitive functioning

  12 weeks

Study Arms (3)

Usual care

NO INTERVENTION

Participants receive their standard of care for PCC, without starting any new medications during study participation.

Metformin

EXPERIMENTAL

Drug: Metformin

Colchicine

EXPERIMENTAL

Drug: colchicine

Interventions

Metformin DRUG

Participants receive metformin tablets for a period of 12-weeks.

Metformin

colchicine DRUG

Participants receive colchicine tablets for a period of 12-weeks.

Colchicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Residing in the Netherlands (but excluding the Carribbean parts of the Netherlands) for the duration of trial participation.
• 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.
• Self-reported confirmation of having had a SARS-CoV-2 infection by:
• Positive SARS-CoV-2 nucleic acid amplification test, such as PCR;
• Positive SARS-CoV-2 rapid diagnostic test, including home-administered tests;
• COVID-19 diagnosis by a medical specialist (GP or in-hospital), based on the above or other clinical tests and assessments.
• The above information will not be verified in medical records.
• Willing and able to provide informed consent.
• Willing and able to perform trial procedures.
• Allowing their GP/treating physicians/pharmacy and the RECLAIM trial team to exchange medical information that is relevant for the participant's safety and trial assessments.

You may not qualify if:

• Having been diagnosed with (exacerbation of) a chronic disease that can account for the onset of the PCC-like symptoms.
• Being hospitalized or institutionalized at screening. Patients can be rescreened after discharge.
• Presence of a serious medical condition that would prevent completion of follow-up.
• 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.
• The participant cannot be randomized to at least one IP arm and its control arm within a trial domain due to:
• Known hypersensitivity to an active IP ingredient or IP/placebo excipient;
• Receiving a treatment that is contraindicated to a trial IP;
• Already using a trial IP, or a drug in the same drug class as a trial IP, outside of the trial;
• Any other reason why a trial IP cannot be used, such as (risk of) pregnancy or breastfeeding or renal insufficiency.

Sponsors & Collaborators

• Janneke van de Wijgert: lead
• European Clinical Research Alliance for Infectious Diseases (ECRAID): collaborator

Study Sites (1)

Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, Netherlands

Utrecht, Netherlands

Location

Related Publications (1)

• van de Wijgert JHHM, Schoevers JMH, Swarthout TD, Bouwman WJT, van Rosmalen J, Leffelaar ER, Lalmohamed A, Loch C, van den Wijngaard CC, Prat-Aymerich C, Schotsman JJ, Verheijen ED, van der Bom JG, Bonten MJM. The RECLAIM adaptive platform trial for the evaluation of treatments for post-COVID condition in the Netherlands: core protocol. Trials. 2026 Feb 19. doi: 10.1186/s13063-026-09570-1. Online ahead of print.

  PMID: 41715140 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Metformin; Colchicine

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The first domain is open label. The second domain (minocyclin versus placebo) will be placebo-controlled and blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

NL (1)