A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19
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|ClinicalTrials.gov Identifier: NCT05263908|
Recruitment Status : Recruiting
First Posted : March 3, 2022
Last Update Posted : March 13, 2023
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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.
|Condition or disease||Intervention/treatment|
|SARS-CoV-2 Infection||Drug: nirmatrelvir / ritonavir|
|Study Type :||Observational|
|Estimated Enrollment :||3300 participants|
|Official Title:||General Investigation for PAXLOVID PAC|
|Actual Study Start Date :||March 31, 2022|
|Estimated Primary Completion Date :||July 10, 2023|
|Estimated Study Completion Date :||July 10, 2023|
Subjects administered PAXLOVID PACK
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
- Incidence of adverse drug reactions [ Time Frame: 34 days ]
- Ratio of subjects with worsening severity [ Time Frame: 34 days ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- Subjects who are administered PAXLOVID PACK and have no history of using this drug.
- There are no exclusion criteria for this study.
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): NCT05263908
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Pfizer Local County||Recruiting|
|Tokyo, Japan, 1518589|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Other Study ID Numbers:||
|First Posted:||March 3, 2022 Key Record Dates|
|Last Update Posted:||March 13, 2023|
|Last Verified:||March 2023|
|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.|
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
coronavirus disease 2019 (COVID-19)
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Nirmatrelvir and ritonavir drug combination
HIV Protease Inhibitors
Viral Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors