COVID-19 Drug TreatmentNCT05997485
A Study to Learn About the Patients With COVID-19 Prescribed Paxlovid in Morocco
An observational study of COVID-19 Drug Treatment, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Drug Treatment
- What is being tested?
- Nirmatrelvir/Ritonavir
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants treated with Paxlovid in single center in Morocco.
Who may be able to join
- Confirmed COVID-19 infection during the study period from 01 June 2022 to 30 June 2023
- Nirmatrelvir, ritonavir written prescription
Who cannot join
- There are no exclusion criteria for this study.
About this study
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.
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.
Read more
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.
- Conditions
- COVID-19 Drug Treatment
- Being tested
- Nirmatrelvir/Ritonavir
- Keywords
- Treatment, Covid Patient, Paxlovid, Morocco
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nirmatrelvir/RitonavirDrug
Also called Paxlovid
Patients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Paxlovid Treatment | Patients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid. Receives: Drug: Nirmatrelvir/Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographical Characteristics of Participants
Measured: Approximately 01 June 2022 through 30 June 2023
Clinical Characteristics of Participants
Measured: Approximately 01 June 2022 through 30 June 2023
Number of Participants with Pre-existing Comorbidities
Measured: Approximately 01 June 2022 through 30 June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start30 Mar 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Drug TreatmentStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997485
- Sponsor's protocol ID
- C4671060
- Status last verified
- Mar 2024
- First submitted
- 15 Aug 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05997485
- Acronym / sponsor ID
- C4671060
- Conditions
- COVID-19 Drug Treatment
- Keywords
- Treatment, Covid Patient, Paxlovid, Morocco
- Study type
- Observational
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Paxlovid Treatment | – | Drug: Nirmatrelvir/RitonavirPatients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants treated with Paxlovid in single center in Morocco.
Key inclusion criteria (2 listed)
- Confirmed COVID-19 infection during the study period from 01 June 2022 to 30 June 2023
- Nirmatrelvir, ritonavir written prescription
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nirmatrelvir/RitonavirAlso: PaxlovidPatients administered oral Paxlovid as prescribed according to national Morocco treatment guidelines for Covid. | Drug | Participants receiving Paxlovid Treatment |
Primary outcome
Demographical Characteristics of Participants
Time frame: Approximately 01 June 2022 through 30 June 2023
Clinical Characteristics of Participants
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Drug Treatment, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographical Characteristics of Participants (time frame: Approximately 01 June 2022 through 30 June 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.