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

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Change in exercise intolerance symptom cluster, as measured by the endurance shuttle walk test (ESWT)