Paxlovid for Long COVID

(RECOVER-VITAL Trial)

Recruiting at 3 trial locations

Overseen By Barrie Harper, BSMT (ASCP) PMP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kanecia Obie Zimmerman

Must not be taking: CYP3A drugs, CYP3A inducers

Disqualifiers: Pregnancy, Breastfeeding, Low eGFR, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3-4 weeks

964 Participants Needed

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Paxlovid or placebo for 15 to 25 days

3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Paxlovid

Trial Overview 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.

Participant Groups

Group I: Paxlovid 25 day dosing Experimental Treatment 1 Intervention

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

Group II: Paxlovid 15 day dosing Experimental Treatment 1 Intervention

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

Group III: Control Placebo Group 1 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:

• COVID-19

Approved in European Union as Paxlovid for:

• COVID-19

Approved in Canada as Paxlovid for:

• COVID-19

Approved in Japan as Paxlovid for:

• COVID-19

Approved in Switzerland as Paxlovid for:

• COVID-19

Who Is Running the Clinical Trial?

Kanecia Obie Zimmerman

Lead Sponsor

Trials

9

Recruited

3,300+