Study Stopped
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.
A Study to Learn About the Patients With COVID-19 Prescribed Paxlovid in Morocco
A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics Among COVID-19 Patients Receiving Treatment With Nirmatrelvir/Ritonavir (PAXLOVIDTM) in Morocco.
1 other identifier
observational
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedStudy Start
First participant enrolled
March 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedMarch 28, 2024
March 1, 2024
3 months
August 15, 2023
March 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Demographical Characteristics of Participants
Approximately 01 June 2022 through 30 June 2023
Clinical Characteristics of Participants
Approximately 01 June 2022 through 30 June 2023
Number of Participants with Pre-existing Comorbidities
Approximately 01 June 2022 through 30 June 2023
Study Arms (1)
Participants receiving Paxlovid Treatment
Patients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid.
Interventions
Patients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid.
Eligibility Criteria
Participants treated with Paxlovid in single center in Morocco.
You may qualify if:
- Confirmed COVID-19 infection during the study period from 01 June 2022 to 30 June 2023
- Nirmatrelvir, ritonavir written prescription
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2023
First Posted
August 18, 2023
Study Start
March 30, 2024
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
March 28, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
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.