RECLAIM Adaptive Platform Trial for PCC Treatments

Other illness

• Having been diagnosed with (exacerbation of) a chronic disease that can account for the onset of the PCC-like symptoms.
• Presence of a serious medical condition that would prevent completion of follow-up.

Lab values

• 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.

Other

• Being hospitalized or institutionalized at screening. Patients can be rescreened after discharge.
• 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):

• 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.