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Antiviral

Paxlovid for Long COVID (RECOVER-VITAL Trial)

Phase 2
Waitlist Available
Led By Kanecia O Zimmerman, MD PhD
Research Sponsored by Kanecia Obie Zimmerman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 90
Awards & highlights

RECOVER-VITAL Trial Summary

This trial looks at potential treatments to help people with long-term symptoms of COVID-19. It tests if antiviral and other therapies can help clear the virus and reduce inflammation, improving symptoms.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Paxlovid may cause side effects like altered taste, diarrhea, high blood pressure, muscle aches. It could also interact with other medications leading to increased side effects from those medicines.

RECOVER-VITAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dysautonomia
Cognition
Change in Exercise intolerance symptom cluster, as measured by the Modified Depaul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM)
Secondary outcome measures
Adherence in intervention versus control groups as measured by number of missed doses
Dysautonomia
Syndrome
+5 more

RECOVER-VITAL Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: Paxlovid 25 day dosingExperimental Treatment1 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 dosingExperimental Treatment1 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: ControlPlacebo Group1 Intervention
Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)

Find a Location

Who is running the clinical trial?

Kanecia Obie ZimmermanLead Sponsor
8 Previous Clinical Trials
2,279 Total Patients Enrolled
Kanecia Zimmerman, MD PhDStudy ChairDuke University
2 Previous Clinical Trials
630 Total Patients Enrolled
Kanecia O Zimmerman, MD PhDPrincipal InvestigatorDuke University

Media Library

Paxlovid (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT05595369 — Phase 2
Long COVID Syndrome Research Study Groups: Experimental: Paxlovid 25 day dosing, Experimental: Paxlovid 15 day dosing, Placebo Comparator: Control
Long COVID Syndrome Clinical Trial 2023: Paxlovid Highlights & Side Effects. Trial Name: NCT05595369 — Phase 2
Paxlovid (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05595369 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a recruitment process for potential participants in this research?

"Clinicaltrials.gov states that this particular clinical trial, posted on July 26th 2023 and last updated August 3rd 2023, is no longer accepting participants. Nevertheless, 126 other trials are enrolling patients at the present time."

Answered by AI

Are there any potential adverse effects of a 25-day regimen with Experimental: Paxlovid?

"The safety rating of Experimental: Paxlovid 25 day dosing is a 2, as this Phase 2 trial has some data to attest to its security but no evidence for efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Swedish Health Services
Banner University Medical Center Phoenix
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms
Kanecia Obie Zimmerman 2023. "RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05595369.
All > Survivor Corps
~548 spots leftby Jul 2025
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