N/A Completed N=3,346

A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19

SARS-CoV-2 infection

Source: ClinicalTrials.gov NCT05263908 ↗

Enrolled (actual)

3,346

Serious AEs

1.8%

Results posted

Sep 2025

Primary outcomePrimary: Incidence of Adverse Drug Reactions — 423; 6 Participants

Summary

The purpose of this post marketing observational study is to learn about the safety and effects of the commercial medicine (called PAXLOVID) for the treatment of COVID-19. This study is intended to be registered with the participants who: * Have taken PAXLOVID PACK and have no history of using this medicine. * Are 12 years and older All participants will receive PAXLOVID, a standard treatment for COVID-19. Participants will take PAXLOVID 2 times a day by mouth or as prescribed. We will examine the experiences of people taking PAXLOVID. This will help us determine if PAXLOVID is safe and effective. Participants will be followed up for 28 days after taking PAXLOVID. During this time, participants will be closely watched for the safety and effects of PAXLOVID.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Drug Reactions	423; 6	—
SECONDARY Percentage of Participants With Worsening Severity (Efficacy Analysis Set #1)	2.19; 94.77; 0; 3.04	—
SECONDARY Percentage of Participants With Worsening Severity (Efficacy Analysis Set #2)	1.63; 94.66; 0; 3.72	—
SECONDARY Percentage of Participants With Worsening Severity (Efficacy Analysis Set #3)	1.68; 94.59; 0; 3.73	—
SECONDARY Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3)	3.99; 4.41; 4.47; 4.80; 4.86; 4.92	—
SECONDARY Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3)	1.42; 1.58; 1.58; 1.75; 1.75; 1.80	—

Eligibility Criteria

Inclusion Criteria

Subjects who are administered PAXLOVID PACK and have no history of using this drug.

Exclusion Criteria

There are no exclusion criteria for this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05263908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.