Post COVID Condition
Conditions
Keywords
Post COVID condition, Clinical trial, Intervention, Repurposed drugs, Metformin, Colchicine, PAIS, Post Acute Sequelae of COVID-19
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.
Interventions
DRUGMetformin
Participants receive metformin tablets for a period of 12-weeks.
DRUGcolchicine
Participants receive colchicine tablets for a period of 12-weeks.
Sponsors
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Janneke van de Wijgert
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The first domain is open label. The second domain (minocyclin versus placebo) will be placebo-controlled and blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older. 2. Residing in the Netherlands (but excluding the Carribbean parts of the Netherlands) for the duration of trial participation. 3. 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. 4. Self-reported confirmation of having had a SARS-CoV-2 infection by: 1. Positive SARS-CoV-2 nucleic acid amplification test, such as PCR; 2. Positive SARS-CoV-2 rapid diagnostic test, including home-administered tests; 3. 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. 5. Willing and able to provide informed consent. 6. Willing and able to perform trial procedures. 7. 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
1. Having been diagnosed with (exacerbation of) a chronic disease that can account for the onset of the PCC-like symptoms. 2. Being hospitalized or institutionalized at screening. Patients can be rescreened after discharge. 3. Presence of a serious medical condition that would prevent completion of follow-up. 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical health-related quality of life (HRQoL) | 12 weeks | PROMIS-29 physical health summary score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other aspects of HRQoL | 12 weeks | PROMIS-29 domain scores: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, sleep disturbance. |
| Fatigue | 12 weeks | Checklist Individual Strength, fatigue severity subscale (CIS-8) |
| Post Exertional Malaise (PEM) | 12 weeks | DePaul Symptom Questionnaire (DSQ-2) PEM questions |
| Cognitive functioning | 12 weeks | PROMIS cognitive function 8a |
| Mental HRQoL | 12 weeks | PROMIS-29 mental health summary score |
| Safety of IPs | 12 weeks | Frequency of related and unrelated (S)AEs and SUSARs in each IP arm including their severity and outcome. |
| Tolerability of IPs | 12 weeks | Level of adherence to each IP. Percent of participants with adequate adherence for the specific IP. |
| Durability of IP treatment responses | 24 weeks | The proportion of participants that maintain HRQoL treatment success at 24 weeks. |
| Post Orthostatic Tachycardia Syndrome (POTS) | 12 weeks | DSQ-2 POTS questions |
Countries
Netherlands
Outcome results
None listed