A Study to Learn About the Patients With COVID-19 Prescribed Paxlovid in Morocco

March 26, 2024 updated by: Pfizer

A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics Among COVID-19 Patients Receiving Treatment With Nirmatrelvir/Ritonavir (PAXLOVIDTM) in Morocco.

The purpose of this study is to collect information on the:

  • general information of a group of people such as their age, sex, and other facts.
  • clinical information of the patients such as any other illness before having COVID 19.

In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.

This study will be conducted in Morocco. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment. The inpatients will be admitted in the hospital for other reasons than COVID-19.

This study will have about 150 patients. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.

The study will include patient information of those who:

  • are confirmed to have COVID-19 infection during the study period from 01 June 2022 to 30 June 2023.
  • are 18 years of age or older.
  • are prescribed Nirmatrelvir and ritonavir. This study will help to inform decision-making on use of Paxlovid at the national level.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants treated with Paxlovid in single center in Morocco.

Description

Inclusion Criteria:

  • Confirmed COVID-19 infection during the study period from 01 June 2022 to 30 June 2023
  • Nirmatrelvir, ritonavir written prescription

Exclusion Criteria:

  • There are no exclusion criteria for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants receiving Paxlovid Treatment
Patients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid.
Drug: Nirmatrelvir/Ritonavir
Patients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid.
Other Names:
  • Paxlovid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demographical Characteristics of Participants
Time Frame: Approximately 01 June 2022 through 30 June 2023
Approximately 01 June 2022 through 30 June 2023
Clinical Characteristics of Participants
Time Frame: Approximately 01 June 2022 through 30 June 2023
Approximately 01 June 2022 through 30 June 2023
Number of Participants with Pre-existing Comorbidities
Time Frame: Approximately 01 June 2022 through 30 June 2023
Approximately 01 June 2022 through 30 June 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4671060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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