RECOVER-VITAL: Platform Protocol, Appendix to Measure the Effects of Paxlovid on Long COVID Symptoms

Exclusion Criteria

• •1. Known pregnancy\*
• •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