The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05263908
Recruitment Status : Completed
First Posted : March 3, 2022
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 25, 2022
First Posted Date March 3, 2022
Last Update Posted Date September 11, 2023
Actual Study Start Date March 31, 2022
Actual Primary Completion Date July 10, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2022)		 Incidence of adverse drug reactions [ Time Frame: 34 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 25, 2022)		 Ratio of subjects with worsening severity [ Time Frame: 34 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19
Official Title General Investigation for PAXLOVID PAC
Brief 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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The subjects who have been treated with PAXLOVID PACK for the first time.
Condition SARS-CoV-2 Infection
Intervention 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 Name: PAXLOVID PACK
Study Groups/Cohorts PAXLOVID PACK
Subjects administered PAXLOVID PACK
Intervention: Drug: nirmatrelvir / ritonavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 25, 2023)		 3346
Original Estimated Enrollment
 (submitted: February 25, 2022)		 3300
Actual Study Completion Date July 10, 2023
Actual Primary Completion Date July 10, 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT05263908
Other Study ID Numbers C4671018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor Pfizer
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2023