Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890612
Status:
RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-06-02
Brief Title:
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
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Post Marketing Surveillance to Observe Safety and Effectiveness of PAXLOVID in Patients With Positive Results of Viral Testing and Who Are at High Risk for Progression to Severe COVID-19
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None