RECOVER-VITAL: Platform Protocol, Appendix to Measure the Effects of Paxlovid on Long COVID Symptoms
Completed · Phase 2 · Has a placebo group
Conditions studied: Long COVID-19, Long COVID
In brief
This is an appendix of master protocol (NCT05595369) 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 sub-study is a prospective, multi-center, double-blind, randomized, controlled trial evaluating nirmatrelvir/ritonavir (Paxlovid) in two dosing durations for the treatment of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The study is evaluating 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 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.
Key facts
- Study ID
- NCT05965726
- Run by
- Kanecia Obie Zimmerman
- People needed
- 964
- Starts
- 2023-07-26
- Expected to finish
- 2025-03-13
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- All sites listed under NCT05595369 — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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