Paxlovid for Long COVID

(RECOVER-VITAL Trial)

Recruiting in Palo Alto (17 mi)

+73 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

Trial Summary

What is the purpose of this trial?

This trial is testing various antiviral and other treatments to help people with long-term COVID-19 symptoms. The goal is to see if these treatments can get rid of any remaining virus, stop it from becoming active again, or calm down the immune system. Participants will receive different treatments to find out which works best.

Research Team

Kanecia Zimmerman, MD PhD

Principal Investigator

Duke University

Richard Whitley, MD

Principal Investigator

University of Alabama at Birmingham Medical Center

Eligibility Criteria

This trial is for adults who've had COVID-19 and are now experiencing Long COVID symptoms persisting for at least 12 weeks. Participants should be able to give consent, complete surveys, and attend follow-up visits. Those with active SARS-CoV-2 infection within the last 4 weeks, severe anemia, moderate/severe immunocompromise, or known allergies to study drugs cannot join.

Inclusion Criteria

I am 18 years old or older.

I have had a COVID-19 infection before.

Meeting PRO Symptom Cluster criteria for at least one Symptom Cluster

Exclusion Criteria

Known severe anemia, defined as < 8 g/dL

Moderate or severe immunocompromised patients, such as those described in the NIH COVID-19 Treatment Guidelines

Currently enrolled in another clinical trial outside this platform protocol or another study intervention appendix in this platform protocol

Treatment Details

Interventions

• Paxlovid (Antiviral)
• Placebo (Drug)

Trial Overview The RECOVER-VITAL trial is testing Paxlovid's effectiveness in treating Long COVID symptoms over two different durations: a 25-day course and a shorter 15-day course. A control group receives a placebo. The study aims to see if antivirals can clear lingering virus or reduce inflammation that might cause Long COVID.

Participant Groups

Group I: Experimental: Paxlovid 25 day dosing Experimental Treatment 1 Intervention

Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)

Group II: Experimental: Paxlovid 15 day dosing Experimental Treatment 1 Intervention

Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)

Group III: Placebo Comparator: Control Placebo Group 1 Intervention

Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)

Paxlovid is already approved in Canada, Japan, Switzerland for the following indications:

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+