Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| D-25-500086 | Other Identifier | NedMec Medical Research Ethics Committee, Utrecht, Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European Clinical Research Alliance for Infectious Diseases (ECRAID) | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Participants receive their standard of care for PCC, without starting any new medications during study participation. | |
| Metformin | Experimental |
| |
| Colchicine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Participants receive metformin tablets for a period of 12-weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Physical health-related quality of life (HRQoL) | PROMIS-29 physical health summary score | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mental HRQoL | PROMIS-29 mental health summary score | 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. |
Not provided
Inclusion criteria
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:
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.
Exclusion criteria:
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 following exclusion criteria will apply to all potential participants WITHIN ONE TRIAL DOMAIN (these patients may still qualify for another trial domain):
The participant cannot be randomized to at least one IP arm and its control arm within a trial domain due to:
During screening, these criteria will be assessed by licensed trial physicians. They will question the patient and verify prescription drug and contraceptive use, and other medical exclusion criteria, in each individual patient's medical and/or pharmacy records. The absence of pregnancy in women of childbearing potential has to be confirmed by a negative urine or serum pregnancy test.
Additional IP-specific in- and exclusion criteria, if any, are listed in relevant treatment-specific appendices to the core protocol. These also describe the latest information about drug interactions and contraindications as per the IP's SmPC/PIL.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, Netherlands | Utrecht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41715140 | Derived | 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;27(1):238. doi: 10.1186/s13063-026-09570-1. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000470 |
Not provided
Not provided
Not provided
Not provided
Not provided
The first domain is open label. The second domain (minocyclin versus placebo) will be placebo-controlled and blinded.
Not provided
| colchicine |
| Drug |
Participants receive colchicine tablets for a period of 12-weeks. |
|
| 12 weeks |
| Fatigue | Checklist Individual Strength, fatigue severity subscale (CIS-8) | 12 weeks |
| Post Exertional Malaise (PEM) | DePaul Symptom Questionnaire (DSQ-2) PEM questions | 12 weeks |
| Cognitive functioning | PROMIS cognitive function 8a | 12 weeks |
| Post Orthostatic Tachycardia Syndrome (POTS) | DSQ-2 POTS questions | 12 weeks |
| Safety of IPs | Frequency of related and unrelated (S)AEs and SUSARs in each IP arm including their severity and outcome. | 12 weeks |
| Tolerability of IPs | Level of adherence to each IP. Percent of participants with adequate adherence for the specific IP. | 12 weeks |
| Durability of IP treatment responses | The proportion of participants that maintain HRQoL treatment success at 24 weeks. | 24 weeks |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Alkaloids |
| D006571 | Heterocyclic Compounds |