Status:
COMPLETED
RECOVER-VITAL: Platform Protocol, Appendix to Measure the Effects of Paxlovid on Long COVID Symptoms
Lead Sponsor:
Kanecia Obie Zimmerman
Conditions:
Long COVID-19
Long COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an appendix of master protocol (NCT05595369) designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be in...
Detailed Description
For this appendix of the master protocol (NCT05595369), participants will be randomized to Paxlovid (nirmatrelvir/ritonavir) vs. ritonavir control plus nirmatrelvir-matching placebo. When there are m...
Eligibility Criteria
Inclusion
- See NCT NCT05595369 for RECOVER-VITAL: Platform Protocol level exclusion criteria which applies to this appendix
- Additional Appendix Level Exclusion Criteria:
- Known pregnancy\*
- Active or expected breastfeeding during the study
- Known eGFR \< 30 mL/min
- Known severe hepatic impairment (Child-Pugh Class C)
- 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
- 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
Exclusion
Key Trial Info
Start Date :
July 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2025
Estimated Enrollment :
964 Patients enrolled
Trial Details
Trial ID
NCT05965726
Start Date
July 26 2023
End Date
March 13 2025
Last Update
April 18 2025
Active Locations (1)
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1
All sites listed under NCT05595369
Durham, North Carolina, United States, 27710