Post COVID ConditionPhase 3RECLAIMNCT07280572
RECLAIM Adaptive Platform Trial for PCC Treatments
A Phase 3 study testing Metformin and colchicine in people with Post COVID Condition, run by Janneke van de Wijgert at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post COVID Condition
- What is being tested?
- Metformin and colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Feb 2025to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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:
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, Netherlands
Utrecht
About this study
Official title: RECLAIM: an Adaptive Platform Trial for the Evaluation of Treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
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
- Being tested
- Metformin, colchicine
- Keywords
- Post COVID condition, Clinical trial, Intervention, Repurposed drugs, Metformin, Colchicine, PAIS, Post Acute Sequelae of COVID-19
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Participants receive metformin tablets for a period of 12-weeks.
colchicineDrug
Participants receive colchicine tablets for a period of 12-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants receive their standard of care for PCC, without starting any new medications during study participation. |
| Metformin | Experimental | Not described Receives: Drug: Metformin |
| Colchicine | Experimental | Not described Receives: Drug: colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical health-related quality of life (HRQoL)
PROMIS-29 physical health summary score
Measured: 12 weeks
Secondary outcomes (9)
Mental HRQoL
PROMIS-29 mental health summary score
Measured: 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.
Measured: 12 weeks
Fatigue
Checklist Individual Strength, fatigue severity subscale (CIS-8)
Measured: 12 weeks
Post Exertional Malaise (PEM)
DePaul Symptom Questionnaire (DSQ-2) PEM questions
Measured: 12 weeks
Cognitive functioning
PROMIS cognitive function 8a
Measured: 12 weeks
Post Orthostatic Tachycardia Syndrome (POTS)
DSQ-2 POTS questions
Measured: 12 weeks
Safety of IPs
Frequency of related and unrelated (S)AEs and SUSARs in each IP arm including their severity and outcome.
Measured: 12 weeks
Tolerability of IPs
Level of adherence to each IP. Percent of participants with adequate adherence for the specific IP.
Measured: 12 weeks
Durability of IP treatment responses
The proportion of participants that maintain HRQoL treatment success at 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start17 Feb 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post COVID ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janneke van de Wijgert
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
- Responsible party
- Sponsor-investigator, Janneke van de Wijgert, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280572
- Sponsor's protocol ID
- EUCT 2024-511580-28
- Other IDs
- D-25-500086
- Acronym
- RECLAIM
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41715140
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECLAIM: an Adaptive Platform Trial for the Evaluation of Treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
- ClinicalTrials.gov ID
- NCT07280572
- Acronym / sponsor ID
- RECLAIM / EUCT 2024-511580-28
- Conditions
- Post COVID Condition
- Keywords
- Post COVID condition, Clinical trial, Intervention, Repurposed drugs, Metformin, Colchicine, PAIS, Post Acute Sequelae of COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Janneke van de WijgertUniversity, hospital or other
- Collaborators
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminParticipants receive metformin tablets for a period of 12-weeks. | Drug | Metformin |
| colchicineParticipants receive colchicine tablets for a period of 12-weeks. | Drug | Colchicine |
Primary outcome
Physical health-related quality of life (HRQoL)
Time frame: 12 weeks
PROMIS-29 physical health summary score
9 secondary outcomes
Mental HRQoL
Time frame: 12 weeks
Other aspects of HRQoL
Time frame: 12 weeks
Fatigue
Time frame: 12 weeks
Post Exertional Malaise (PEM)
Time frame: 12 weeks
Cognitive functioning
Time frame: 12 weeks
Post Orthostatic Tachycardia Syndrome (POTS)
Time frame: 12 weeks
Safety of IPs
Time frame: 12 weeks
Tolerability of IPs
Time frame: 12 weeks
Durability of IP treatment responses
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 41715140van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin and colchicine in people with Post COVID Condition, run by Janneke van de Wijgert at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical health-related quality of life (HRQoL) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07280572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.