Back to resultsEfficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study
Primary Purpose
COVID-19 Pneumonia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
standard-of-care plus Paxlovid
standard-of-care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Patients with confirmed COVID-19 who had taken more than one dose of Paxlovid.
Exclusion Criteria:
- Age < 18 years-old;
- Pregnancy;
- Data missing > 20%.
Sites / Locations
- Ruijin Hospital, Medical School of Shanghai Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
standard-of-care
standard-of-care plus Paxlovid
Arm Description
Outcomes
Primary Outcome Measures
28-day mortality
the mortality of the subjects within 28 days since the diagnosis of COVID-19
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05532852
Brief Title
Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study
Official Title
Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
COVID-19 is currently one of the serious public health challenges worldwide, and there is a great need to develop effective treatments. Paxlovid is a Pfizer-developed oral new drug for the treatment of COVID-19. Paxlovid, which is used to treat adult patients with mild to moderate COVID-19 who have high-risk factors for progression to severe disease, was conditionally approved for marketing in the United States and China in December 2021 and February 2022, respectively. Clinical trials have shown that this drug can significantly reduce the progression from mild to severe disease and the rate of hospitalization and mortality. However, due to the limitations of clinical trials in the subject selection, there is still insufficient knowledge about the efficacy and safety of Paxlovid in a real-world population. Relevant studies on this drug in real-world people, especially in Chinese populations, have not been reported. Therefore, this study was designed to investigate the efficacy and safety of Paxlovid on sufferers of COVID-19 through a retrospective, real-world analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
728 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard-of-care
Arm Type
Sham Comparator
Arm Title
standard-of-care plus Paxlovid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
standard-of-care plus Paxlovid
Intervention Description
standard-of-care plus Paxlovid
Intervention Type
Drug
Intervention Name(s)
standard-of-care
Intervention Description
standard-of-care
Primary Outcome Measure Information:
Title
28-day mortality
Description
the mortality of the subjects within 28 days since the diagnosis of COVID-19
Time Frame
28 days since the diagnosis of COVID-19
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with confirmed COVID-19 who had taken more than one dose of Paxlovid.
Exclusion Criteria:
Age < 18 years-old;
Pregnancy;
Data missing > 20%.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jieming Qu, PhD
Phone
+862164370045
Email
jmqu0906@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jieming Qu
Organizational Affiliation
Rui-jin Hospital, Shanghai Jiao-tong University School of Medicine, Shanghai,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital, Medical School of Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jieming Qu, MD, PhD
Phone
86-21-64370045
Email
jmqu0906@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study
We'll reach out to this number within 24 hrs