Paxlovid for Long COVID
(RECOVER-VITAL Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kanecia Obie Zimmerman

Prior Safety Data

Approved in 5 Jurisdictions

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

See NCT NCT05595369 for RECOVER-VITAL: Platform Protocol level

Participant Groups

The study tests Paxlovid at two different dosing durations (15 days and 25 days) against a control group to see if it helps with Long COVID symptoms. It's double-blind, meaning neither doctors nor patients know who gets what treatment, ensuring unbiased results.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Paxlovid 25 day dosingExperimental Treatment1 Intervention

Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days

Group II: Paxlovid 15 day dosingExperimental Treatment1 Intervention

Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 15 days then ritonavir 100mg plus nirmatrelvir-matching placebo x 10 days

Group III: ControlPlacebo Group1 Intervention

ritonavir 100mg plus nirmatrelvir-matching placebo bid x 25 days

Paxlovid is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:

🇺🇸 Approved in United States as Paxlovid for: