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

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: NCT05997485
Recruitment Status : Withdrawn (The study was prematurely discontinued due to the substantial delay in initiation the study. This decision was not due to major safety concerns or requests from any regulatory authorities.)
First Posted : August 18, 2023
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment
COVID-19 Drug Treatment Drug: Nirmatrelvir/Ritonavir

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics Among COVID-19 Patients Receiving Treatment With Nirmatrelvir/Ritonavir (PAXLOVIDTM) in Morocco.
Estimated Study Start Date : March 30, 2024
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: Paxlovid


Outcome Measures
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Primary Outcome Measures :
  1. Demographical Characteristics of Participants [ Time Frame: Approximately 01 June 2022 through 30 June 2023 ]
  2. Clinical Characteristics of Participants [ Time Frame: Approximately 01 June 2022 through 30 June 2023 ]
  3. Number of Participants with Pre-existing Comorbidities [ Time Frame: Approximately 01 June 2022 through 30 June 2023 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants treated with Paxlovid in single center in Morocco.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05997485


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05997485    
Other Study ID Numbers: C4671060
First Posted: August 18, 2023    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024
Individual Participant Data (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.
Keywords provided by Pfizer:
Treatment
Covid Patient
Paxlovid
Morocco
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
 Nirmatrelvir
Nirmatrelvir and ritonavir drug combination
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors