RECOVER-VITAL: Platform Protocol, Appendix to Measure the Effects of Paxlovid on Long COVID Symptoms
NCT ID: NCT05965726
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
964 participants
INTERVENTIONAL
2023-07-26
2025-03-13
Brief Summary
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RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms
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A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19
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Detailed Description
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When there are multiple study interventions (sub-studies) available under the master protocol (NCT05595369), randomization will occur based on the specific inclusion/exclusion criteria of each appendix.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Participants must meet certain criteria within a specific symptom cluster in order to be included in the cluster. After study enrollment and initial cluster assignment, further assessments will be performed. Participants will undergo assessments for the symptom clusters for which the participants qualify.
TREATMENT
TRIPLE
Study Groups
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Paxlovid 25 day dosing
Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 25 days
Paxlovid 25 day dosing
Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 30 days
Paxlovid 15 day dosing
Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 15 days then ritonavir 100mg plus nirmatrelvir-matching placebo x 10 days
Paxlovid 15 day dosing
Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 15 days then ritonavir 100mg taken BID plus nirmatrelvir matching placebo BID for 15 days
Ritonavir plus nirmatrelvir-matching placebo
Ritonavir 100mg plus nirmatrelvir-matching placebo BID (twice a day) x 25 days
Ritonavir plus nirmatrelvir-matching placebo
Ritonavir 100mg taken BID (twice a day) plus nirmatrelvir matching placebo BID for 30 days
Interventions
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Paxlovid 25 day dosing
Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 30 days
Paxlovid 15 day dosing
Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 15 days then ritonavir 100mg taken BID plus nirmatrelvir matching placebo BID for 15 days
Ritonavir plus nirmatrelvir-matching placebo
Ritonavir 100mg taken BID (twice a day) plus nirmatrelvir matching placebo BID for 30 days
Eligibility Criteria
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Exclusion Criteria
2. Active or expected breastfeeding during the study
3. Known eGFR \< 30 mL/min
4. Known severe hepatic impairment (Child-Pugh Class C)
5. Current use of drugs highly dependent on CYP3A for clearance\*\* and for which elevated concentrations are associated with serious and/or life-threatening reactions and which cannot be interrupted during the time of study administration and within seven days before and after study drug administration
6. Current use of potent CYP3A inducers\*\* where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance
* A pregnancy test must be performed at the Baseline Visit for participants who are capable of becoming pregnant.
* A guide of drugs that may be contraindicated are listed in Section 4 CONTRAINDICATIONS of the Full Prescribing Information of the EUA for PAXLOVID. https://labeling.pfizer.com/ShowLabeling.aspx?id=16474\&format=pdf
18 Years
ALL
No
Sponsors
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Kanecia Obie Zimmerman
OTHER
Responsible Party
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Kanecia Obie Zimmerman
Associate Professor of Pediatrics
Locations
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All sites listed under NCT05595369
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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OTA-21-015G
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00111697_A
Identifier Type: -
Identifier Source: org_study_id
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