A Study on Paxlovid Once in the Market, to Observe Its Safety and Effectiveness in Patients Who Have a High Chance of Getting Severe COVID-19

COVID-19 Clinical Trial

Official title:

Post Marketing Surveillance to Observe Safety and Effectiveness of PAXLOVID in Patients, and Who Are at High Risk for Progression to Severe COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05890612
• Other study ID #: C4671020
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: July 13, 2029

Study information

• Verified date: October 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to look at the safety and effectiveness of PAXLOVID in the real world and not in clinical studies. The study observes patients who have a high chance of getting severe COVID-19 in Korea.

This study is seeking participants who are:

• Patients with mild-to-moderate COVID-19 symptoms and at high chance of getting severe COVID-19, including hospitalization or death.

• Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.

• Patients who have signed informed consent documents after understanding all the important parts of the study.

All participants are treated according to routine medical practice and there are no scheduled visits required by this study. All participants will be studied for a follow-up period of 28 days from the last PAXLOVID treatment to understand the safety and the effectiveness of treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: July 13, 2029
• Est. primary completion date: July 13, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.

• Patients (or a legally acceptable representative) who are willing to provide written informed consent/assent prior to study enrollment.

Exclusion Criteria:

• Patients with contraindication according to locally approved label of PAXLOVID.

• Patients who are going to receive any investigational medicine during the observation period.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with an adverse event (AE)	The number of AEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.	Baseline through Day 33
Primary	Proportion of patients with an adverse drug reaction (ADR)	The number of ADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.	Baseline through Day 33
Primary	Proportion of patients with a serious AE (SAE)	The number of SAEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.	Baseline through Day 33
Primary	Proportion of patients with a serious ADR (SADR)	The number of SADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.	Baseline through Day 33
Primary	Proportion of patients with an unexpected AE (UAE)	The number of UAEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.	Baseline through Day 33
Primary	Proportion of patients with an unexpected ADR (UADR)	The number of UADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.	Baseline through Day 33
Primary	Proportion of patients with a serious unexpected AE (SUAE)	The number of SUAEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.	Baseline through Day 33
Primary	Proportion of patients with a serious unexpected ADR (SUADR)	The number of SUADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.	Baseline through Day 33
Primary	Proportion of COVID-19-related hospitalization from any cause	The number and rate of COVID-19-related hospitalizations among all subjects who received the drug and received at least one safety evaluation will be measured.	Baseline through Day 33
Primary	Proportion of COVID-19-related death from any cause	The number and rate of COVID-19-related deaths among all subjects who received the drug and received at least one safety evaluation will be measured.	Baseline through Day 33
Primary	Proportion of subjective assessment of COVID-19-related symptomatic change	The rate of subjective assessment change (improve/no change/worsened) compared to the baseline for COVID-19-related overall symptoms of all subjects who received the drug and received at least one safety evaluation will be measured.	Day 5, Day 14, Day 33