The RECLAIM adaptive platform trial for the evaluation of treatments for post-COVID condition in the Netherlands: core protocol
van de Wijgert, Janneke HHM Schoevers, Julie MH Swarthout, Todd D Bouwman, Wietske JT van Rosmalen, Joost Leffelaar, Evelien R Lalmohamed, Arief Loch, Chantal van den Wijngaard, Cees C Prat-Aymerich, Cristina
van de Wijgert, Janneke HHM
Schoevers, Julie MH
Swarthout, Todd D
Bouwman, Wietske JT
van Rosmalen, Joost
Leffelaar, Evelien R
Lalmohamed, Arief
Loch, Chantal
van den Wijngaard, Cees C
Prat-Aymerich, Cristina
Series / Report no.
Open Access
Type
Journal Article
Clinical Trial Protocol
Article
Clinical Trial Protocol
Article
Language
en
Date of publication
2026-02-19
Year of publication
Research Projects
Organizational Units
Journal Issue
Title
The RECLAIM adaptive platform trial for the evaluation of treatments for post-COVID condition in the Netherlands: core protocol
Translated Title
Published in
Trials 2026; 27(1):238
Abstract
BACKGROUND: Post-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.
METHODS: RECLAIM 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 REGISTRATION: European 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.