A Study to Understand How the Use of Paxlovid Affected Healthcare Use in People With Pre-existing Conditions.

NCT07090486 | Completed FDA Drug

• 1 other identifier: C4671067
• Study Type: observational
• Target: 14,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cohort study that will include Paxlovid (nirmatrelvir-ritonavir) treatment eligible for people with a positive SARS-CoV-2 diagnostic test and at least one COVID-19 symptom. This study will look at the change in Post Covid Conditions measured by the number of outpatients, Emergency department, urgent care and inpatient visits before and after COVID-19 between those who did and did not receive Paxlovid. In addition, changes in frailty post-acute infection will be evaluated, in a separate analysis. It is hypothesized that individuals with COVID-19 who received Paxlovid will have a smaller post-COVID-19 increase (vs pre-COVID) in PCC healthcare utilization (i.e., cardiopulmonary) in comparison to patients with COVID-19 who did not receive Paxlovid.

Conditions

COVID-19

Keywords

Coronavirus-19 disease (COVID-19); Kaiser Permanente Southern California (KPSC); post-COVID conditions (PCC); Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2); Long COVID; nirmatrelvir-ritonavir

Outcome Measures

Primary Outcomes (1)

• Cardio-pulmonary Measurement A: Change in rate of cardiopulmonary-related healthcare utilization in patients that received nirmatrelvir-ritonavir compared to not received.

  180 days before COVID-19 symptoms to 180 days after or 365 days after

Secondary Outcomes (1)

• Frailty Measurement A: Change in frailty measured by Frailty score Median (IQR) in patients that did receive in patients nirmatrelvir-ritonavir compared to not received.

  During Pre-period: 12 months prior to symptom onset Frailty score Median (IQR) to 12 months after.

Study Arms (2)

Participants who received nirmatrelvir-ritonavir

Patients with cardio-pulmonary conditions

Drug: nirmatrelvir-ritonavir

Participants who did not received nirmatrelvir-ritonavir

Patients with cardio-pulmonary conditions

Interventions

nirmatrelvir-ritonavir DRUG

Paxlovid standard of treatment care

Also known as: Paxlovid

Participants who received nirmatrelvir-ritonavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Members of the Kaiser Permanente Southern California integrated healthcare delivery system.

You may qualify if:

• Developed at least one COVID-19 symptom between Apr 1, 2022 through Dec 31, 2023
• A positive lab-confirmed polymerase chain reaction (PCR) SARS-COV-2 test 5 days after symptom onset (primary analysis).
• Continuous enrollment in KPSC health plans for at least 1 year (allowing for a 31-day gap to account for potential delays in membership renewal) before the date of symptom onset
• Active membership in KPSC health plans for at least 31 days after the date of symptom onset
• Eligible for nirmatrelvir-ritonavir defined by age and CDC-defined risk factors for severe COVID-19

You may not qualify if:

• Individuals on another medication that is contraindicated for treatment with nirmatrelvir-ritonavir defined as having any prescription drug claim in the 90 days prior to COVID-19 symptom onset
• Receipt of any COVID-19 antiviral (molnupiravir, remdesivir, nirmatrelvir/ritonavir) or monoclonal antibody treatment (bamlanivimab, bebtelovimab, casirivimab/imdevimab, cilgavimab/tixagevimab, otrovimab,) \<180 days prior to COVID-19 symptom onset
• Any positive SARS-CoV-2 test, including self-reported tests, \<180 days prior to COVID-19 symptom onset.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New York

New York, New York, 10001, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: April 15, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)