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RECLAIM: an Adaptive Platform Trial for the Evaluation of Treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
EU CTIS ID: 2024-511580-28-02
What this study is testing
To determine the impact of each IP vs. control on patient-reported physical health-related quality of life (HRQoL)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults aged 18 years or older.
- Residing in the study area (defined in each respective CSA) for the duration of trial participation.
- Persistent PASC signs and 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: a. Positive SARS-CoV-2 nucleic acid amplification test (NAAT), such as PCR; b. Positive SARS-CoV-2 rapid diagnostic test, including home-administered tests; c. COVID-19 diagnosis by a treating physician (GP or medical specialist), based on the above or other clinical tests and assessments. Alternatively, a treating physician may have diagnosed the patient with PASC, thereby implicitly acknowledging that the patient had COVID-19 in the past.
- Willing and able to provide informed consent
- Willing and able to perform trial procedures
You likely can't join if
- Having been diagnosed with (exacerbation of) a chronic disease that can account for the onset of the PASC-like symptoms.
- Being hospitalised or institutionalised 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.
- Having initiated chronic use of a new licensed medication for any indication in the three months prior to the eligibility confirmation by a trial physician. This criterion may be reassessed after sufficient time has passed. Similarly, the potential participant should commit to not starting any chronic use of new licensed medications for any indication between eligibility confirmation and Week-12 unless medically necessary as determined by a treating physician (see section 8.1.1.1).
- The following exclusion criteria will apply to all potential participants WITHIN ONE TRIAL DOMAIN (these patients may still qualify for another trial domain): 6 The participant cannot be randomised to at least one IP arm and its control arm within a trial domain due to (refer to relevant TSAs for details): a. Known hypersensitivity to an active IP ingredient or IP/placebo excipient; b. Receiving a treatment that is contraindicated to a trial IP; c. Already using a trial IP, or a drug in the same drug class as a trial IP, outside of the trial; d. Any other reason why a trial IP cannot be used, such as (risk of) pregnancy or breastfeeding or renal insufficiency.
See the full eligibility criteria
Who can join
- Adults aged 18 years or older.
- Residing in the study area (defined in each respective CSA) for the duration of trial participation.
- Persistent PASC signs and 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: a. Positive SARS-CoV-2 nucleic acid amplification test (NAAT), such as PCR; b. Positive SARS-CoV-2 rapid diagnostic test, including home-administered tests; c. COVID-19 diagnosis by a treating physician (GP or medical specialist), based on the above or other clinical tests and assessments. Alternatively, a treating physician may have diagnosed the patient with PASC, thereby implicitly acknowledging that the patient had COVID-19 in the past.
- Willing and able to provide informed consent
- Willing and able to perform trial procedures
- Allowing their GP/pharmacy and the RECLAIM trial team to exchange medical information that is relevant for the participant’s safety and trial assessments.
What rules you out
- Having been diagnosed with (exacerbation of) a chronic disease that can account for the onset of the PASC-like symptoms.
- Being hospitalised or institutionalised 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.
- Having initiated chronic use of a new licensed medication for any indication in the three months prior to the eligibility confirmation by a trial physician. This criterion may be reassessed after sufficient time has passed. Similarly, the potential participant should commit to not starting any chronic use of new licensed medications for any indication between eligibility confirmation and Week-12 unless medically necessary as determined by a treating physician (see section 8.1.1.1).
- The following exclusion criteria will apply to all potential participants WITHIN ONE TRIAL DOMAIN (these patients may still qualify for another trial domain): 6 The participant cannot be randomised to at least one IP arm and its control arm within a trial domain due to (refer to relevant TSAs for details): a. Known hypersensitivity to an active IP ingredient or IP/placebo excipient; b. Receiving a treatment that is contraindicated to a trial IP; c. Already using a trial IP, or a drug in the same drug class as a trial IP, outside of the trial; d. Any other reason why a trial IP cannot be used, such as (risk of) pregnancy or breastfeeding or renal insufficiency.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.