ImPROving Quality of LIFe in the Long COVID Patient

Korábbi kezelés

• Previous Paxlovid treatment.
• Drug-drug interaction with ongoing treatment, including concomitant use of any medications or substances that are strong inducers of CYP3A4 within 28 days prior to first dose of nirmatrelvir/ritonavir and during study treatment.
• Previous administration with any investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
• Known prior participation in this trial or other trial involving nirmatrelvir.
  • Diagnostic Assessments:

Más betegség

• Other non-related conditions with PACS like symptoms.
• Active COVID-19 infection as verified by SARS CoV-2 positive antigen test.
• History of hospitalization for the medical treatment of acute COVID-19
• Is unwilling to abstain from participating in another interventional clinical study with an investigational compound or device, including those for post-COVID-19 therapeutics, through the long-term follow-up visit.

Laborértékek

• Renal function eGFR eGFRCysC \< 60 mL/min/1.73 m2.
• Self-reported medical conditions, including:
  • Type 1 or Type 2 diabetes mellitus.
  • Chronic kidney disease.
  • Neurodevelopmental disorders (e.g., cerebral palsy, Down's syndrome) or other conditions that confer medical complexity (e.g., genetic or metabolic syndromes and severe congenital anomalies).
  • Active cancer other than localized skin cancer, including those requiring treatment including palliative treatment), as long as the treatment is not among the prohibited medications that must be administered/continued during the trial period.
  • Immunosuppressive disease (e.g., bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications:
  • Has received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry.
  • Has received treatment with biologics (e.g., infliximab, ustekinumab, etc.), immunomodulators (e.g., methotrexate, 6MP, azathioprine, etc.), or cancer chemotherapy within 90 days prior to study entry.
  • HIV infection with CD4+ cell count \<200/mm3.
• Prior/Concomitant Therapy:
  • Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance, and for which elevated plasma concentrations may be associated with serious and/or life-threatening events during treatment and for 4 days after the last dose of nirmatrelvir/ritonavir. List of potential interactions provided by Pfizer provided in Appendix A.
  • Has received or is expected to receive monoclonal antibody treatment, antiviral treatment (e.g., molnupiravir), or convalescent COVID-19 plasma.
  • Prior/Concurrent Clinical Study Experience:
• Known history of any of the following abnormalities in clinical laboratory tests (within past 6 months of the screening visit):
  • AST or ALT level ≥2.5 X ULN
  • Total bilirubin ≥2 X ULN (≥3 X ULN for Gilbert's syndrome)

Egyéb

• General exclusion criteria
• Not able to comply with the study protocol.
• Pregnancy or breastfeeding.
• Participants who are planning or considering vaccination (including boosters) through Study Day 45.
• Current need for hospitalization or anticipated need for hospitalization within 48 hours after randomization in the clinical opinion of the site investigator.

• The subject has given written consent to participate in the study.
• ≥18 years of age at the time of the Screening Visit.
• Post-acute COVID-19 syndrome (PACS) according to the WHO definition.
• EQ-5D-5L VAS ≤ 50
• All fertile participants must agree to use a highly effective method of contraception for the duration of the study and 28 days after last intake of the IMP.