Evidence map›Paper›PMID 41715140›Full record

ArticleTrials2026

The RECLAIM adaptive platform trial for the evaluation of treatments for post-COVID condition in the Netherlands: core protocol.

Janneke H H M van de Wijgert, Julie M H Schoevers, Todd D Swarthout, Wietske J T Bouwman, Joost van Rosmalen, Evelien R Leffelaar, Arief Lalmohamed, Chantal Loch, Cees C van den Wijngaard, Cristina Prat-Aymerich and 4 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07280572 (RECLAIM), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07280572 phase3enrolling by invitationnot on this map

RECLAIM: an Adaptive Platform Trial for the Evaluation of Treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

TypeinterventionalSponsorJanneke van de WijgertRan2025 to 2027Enrolled1,250ConditionsPost COVID ConditionArmsMetformin, colchicine
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Janneke H H M van de WijgertJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, Stratenum Room 6.131, Utrecht, 3584 CG, The Netherlands. j.h.h.vandewijgert@umcutrecht.nl.
Julie M H SchoeversJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, Stratenum Room 6.131, Utrecht, 3584 CG, The Netherlands.
Todd D SwarthoutJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, Stratenum Room 6.131, Utrecht, 3584 CG, The Netherlands.
Wietske J T BouwmanEuropean Clinical Research Alliance on Infectious Diseases (Ecraid), Utrecht, The Netherlands.
Joost van RosmalenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, Stratenum Room 6.131, Utrecht, 3584 CG, The Netherlands.
Evelien R LeffelaarJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, Stratenum Room 6.131, Utrecht, 3584 CG, The Netherlands.
Arief LalmohamedPharmacy, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Chantal LochEuropean Clinical Research Alliance on Infectious Diseases (Ecraid), Utrecht, The Netherlands.
Cees C van den WijngaardCentre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Cristina Prat-AymerichJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, Stratenum Room 6.131, Utrecht, 3584 CG, The Netherlands.
Joost J SchotsmanJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, Stratenum Room 6.131, Utrecht, 3584 CG, The Netherlands.
Eveline D VerheijenEuropean Clinical Research Alliance on Infectious Diseases (Ecraid), Utrecht, The Netherlands.
Johanna G van der BomDepartment of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
Marc J M BontenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, Stratenum Room 6.131, Utrecht, 3584 CG, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPost-COVID condition (PCC) encompasses a heterogeneous spectrum of pathological responses to SARS-CoV-2 infection, with unknown individual predispositions. No evidence-based, curative treatments are available. Many patients therefore resort to off-label use of medications originally developed for other indications. However, the efficacy and safety of repurposed drugs in the context of PCC are unknown.

methodsRECLAIM is a phase III, randomised, controlled, adaptive platform trial. The trial population consists of adult patients who have had persistent PCC symptoms, including fatigue and/or post-exertional malaise, 12 or more weeks after the onset of a SARS-CoV-2 infection. Randomisation occurs within trial domains. A trial domain consists of one or multiple investigational products (IPs), each to be compared to one usual care arm, or one or multiple IPs, each to be compared to a matching placebo. Within each trial domain, patients can be enrolled if they are eligible for at least one IP and its control. They are randomised with equal probability to each arm for which they are eligible. Trial product use (if applicable) starts as soon as possible after randomisation for a default duration of 12 weeks. Study procedures are implemented remotely, using video consultations, eConsenting, trial product delivery to participants' homes (if applicable), and online questionnaires at baseline, day 1, and weeks 2, 4, 6, 8, 10, 12, and 24. The primary outcome is health-related quality of life at week 12, assessed by Patient-Reported Outcomes Measurement Information System Profile29 (PROMIS-29) physical health summary scores, and is analysed with a Bayesian analysis of covariance model with adjustment for the baseline value. Secondary outcomes include week 12 PROMIS-29 mental health summary scores and topic domain scores; specific PCC symptoms using other patient-reported outcome measures, safety, and tolerability; and durability of treatment responses at week 24. Participants are allowed to participate in only one trial domain at a time, but can be rerandomised into a different trial domain after completing week 24. DISCUSSION: RECLAIM commenced in February 2025 with an open-label domain including two IP arms (metformin and colchicine) and one usual care control arm. A second placebo-controlled domain, comparing minocycline to a matching placebo, was initiated in February 2026.

trial registrationEuropean Clinical Trials Information System (CTIS) EUCT number 2024-511580-28-02 . Registered on 9 October 2024. CLINICALTRIALS: gov identifier NCT07280572 . Registered on 11 December 2025.

Indexed as

ColchicineCOVID-19COVID-19 Drug TreatmentAdaptive Clinical Trials as TopicClinical Trial Protocols as TopicClinical Trials, Phase III as TopicFatigueHumansNetherlandsPandemicsPost-Acute COVID-19 SyndromeQuality of LifeRandomized Controlled Trials as TopicResearch DesignSARS-CoV-2Treatment OutcomeColchicineAdaptive platform trialColchicineMetforminMinocyclinePost-COVID condition

Identifiers

PMID41715140
PMCPMC13020272

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.