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General Investigation for PAXLOVID PACK

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05263908
Collaborator
(none)
3,300
Enrollment
1
Location
15.3
Anticipated Duration (Months)
215.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Post-marketing study, secondary data collection: Examine the safety and effectiveness of PAXLOVID PACK under actual medical practice.

Condition or Disease Intervention/Treatment Phase
  • Drug: nirmatrelvir / ritonavir

Detailed Description

This is a multicenter cohort study to be conducted in individuals with SARS-CoV-2 infection who are treated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through medical records.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3300 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
General Investigation for PAXLOVID PAC
Actual Study Start Date :
Mar 31, 2022
Anticipated Primary Completion Date :
Jul 10, 2023
Anticipated Study Completion Date :
Jul 10, 2023

Arms and Interventions

Arm Intervention/Treatment
PAXLOVID PACK

Subjects administered PAXLOVID PACK

Drug: nirmatrelvir / ritonavir
The usual dosage in adults and pediatric patients (≥12 years of age weighing ≥40 kg) is 300 mg of Nirmatrelvir and 100 mg of ritonavir all taken together orally twice daily for 5 days.
Other Names:
  • PAXLOVID PACK

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse drug reactions [34 days]

    Secondary Outcome Measures

    1. Ratio of subjects with worsening severity [34 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Local County Tokyo Japan 1518589

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05263908
    Other Study ID Numbers:
    • C4671018
    First Posted:
    Mar 3, 2022
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pfizer
    severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
    coronavirus disease 2019 (COVID-19)
    Paxlovid
    Nirmatrelvir
    Additional relevant MeSH terms:
    COVID-19
    Ritonavir

    Study Results

    No Results Posted as of May 19, 2022