RECLAIM Adaptive Platform Trial for PCC Treatments

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Metformin
  Participants receive metformin tablets for a period of 12-weeks.
• Препарат colchicine
  Participants receive colchicine tablets for a period of 12-weeks.

Первичные конечные точки

• Physical health-related quality of life (HRQoL) [Срок оценки: 12 weeks]

Вторичные конечные точки (9)

• Mental HRQoL [Срок оценки: 12 weeks]
• Other aspects of HRQoL [Срок оценки: 12 weeks]
• Fatigue [Срок оценки: 12 weeks]
• Post Exertional Malaise (PEM) [Срок оценки: 12 weeks]
• Cognitive functioning [Срок оценки: 12 weeks]
• Post Orthostatic Tachycardia Syndrome (POTS) [Срок оценки: 12 weeks]
• Safety of IPs [Срок оценки: 12 weeks]
• Tolerability of IPs [Срок оценки: 12 weeks]
• Durability of IP treatment responses [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• 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;
• 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.

Критерии исключения

• 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:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, Neth — Utrecht

Публикации

• 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- PMID 41715140

Идентификаторы

NCT: NCT07280572 · EUCT 2024-511580-28 · D-25-500086

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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