Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

See NCT NCT05595369 for RECOVER-VITAL: Platform Protocol level exclusion criteria which
applies to this appendix

Additional Appendix Level 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