This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, double-blind, randomized, controlled platform trial with different interventions organized as appendices to the protocol. Each appendix (or sub-study) evaluates potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection, viral reactivation, and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms.
Participants will be randomized to study interventions or placebo/controls based on the arms that are actively enrolling at the time of randomization. Study interventions may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study interventions available, randomization will occur based on appropriateness of each intervention for the participant as determined by the study protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
963
Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)
Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)
Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona/Banner University Medical Center Phoenix
Phoenix, Arizona, United States
University of Arizona Banner Medical Center
Tucson, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
Total Number of Participants Enrolled in Each Appendix
Appendix-specific outcome measure data will be reported under the associated NCT ID.
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California San Francisco General Hospital
San Francisco, California, United States
Stanford University
Stanford, California, United States
Los Angeles Biomedical Institute at Harbor-UCLA Medical Center
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
...and 59 more locations