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Antiviral

Paxlovid for Long COVID (RECOVER-VITAL Trial)

Phase 2

Waitlist Available

Research Sponsored by Kanecia Obie Zimmerman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

See NCT NCT05595369 for RECOVER-VITAL: Platform Protocol level

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 tests new drugs to see if they can help people with long-term COVID-19 symptoms. It looks at how the drugs work, how well they work, and if they're safe.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, Paxlovid may cause taste disturbances, diarrhea, high blood pressure and muscle aches. Side effects vary from person to person.

RECOVER-VITAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

RECOVER-VITAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 90

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

Change in autonomic dysfunction symptom cluster, as measured by the orthostatic hypotension questionnaire (OHQ)

Change in cognitive dysfunction symptom cluster, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function T-score

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

Change in autonomic dysfunction symptom cluster, as measured by the active stand test

Change in cognitive dysfunction symptom cluster, as measured by a neurocognitive battery

+6 more

RECOVER-VITAL Trial Design

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kanecia Obie ZimmermanLead Sponsor

8 Previous Clinical Trials

2,277 Total Patients Enrolled

Media Library

Paxlovid (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT05965726 — Phase 2

Long COVID Syndrome Research Study Groups: Control, Paxlovid 15 day dosing, Paxlovid 25 day dosing

Long COVID Syndrome Clinical Trial 2023: Paxlovid Highlights & Side Effects. Trial Name: NCT05965726 — Phase 2

Paxlovid (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05965726 — Phase 2

Frequently Asked Questions

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

Does this experiment require any additional participants?

"The page for this trial on clinicaltrials.gov states that recruitment is no longer taking place, as the study was initially posted 26th July 2023 and last updated 3rd August 2023. However, 126 other trials are actively recruiting at present."

Answered by AI

Is the twenty-five day dosing schedule of Paxlovid officially sanctioned by the Food and Drug Administration?

"Data supporting the safety of Paxlovid 25 day dosing is available, resulting in it being rated a 2. However, there are no studies showing its effectiveness yet."

Answered by AI