Paxlovid for Long COVID
(RECOVER-VITAL Trial)
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for individuals experiencing Long COVID symptoms. Participants should fit the broader criteria outlined in the master protocol (NCT05595369). Specific details on who can join are not provided here, but typically include those with a confirmed history of COVID-19 and ongoing health issues related to it.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Paxlovid or placebo for 15 to 25 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Paxlovid
Paxlovid is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:
- COVID-19
- COVID-19
- COVID-19
- COVID-19
- COVID-19
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kanecia Obie Zimmerman
Lead Sponsor