RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symp… (NCT05595369) | Clinical Trial Compass
CompletedPhase 2
RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms
United States963 participantsStarted 2023-07-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years of age at the time of enrollment
✓. Previous suspected, probably or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization\*
✓. At least two moderate symptoms from the same symptom cluster or one severe cluster-associated symptom identified via the Cluster Targeted COVID-19 Symptom Questions (CTCSQ), with participant identifying new symptoms since COVID-19 illness and having persisted for at least 12 weeks
✓. Meeting PRO Symptom Cluster criteria for at least one Symptom Cluster
✓. Willing and able to provide informed consent, complete the surveys, clinical assessments, and return for all of the necessary follow-up visits
Exclusion criteria
✕. Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
✕. Known severe anemia, defined as \< 8 g/dL
✕. Meeting the following symptom cluster exclusion for all eligible clusters\*:
✕
What they're measuring
1
Total Number of Participants Enrolled in Each Appendix