Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study

COVID-19 Pneumonia Clinical Trial

Official title:

Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532852
• Other study ID #: KY01004
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: September 2022
• Source: Ruijin Hospital
• Contact: Jieming Qu, PhD
• Phone: +862164370045
• Email: jmqu0906[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 728
• Est. completion date: October 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia

Intervention

Drug:
• standard-of-care plus Paxlovid
standard-of-care plus Paxlovid
• standard-of-care
standard-of-care

Locations

Country	Name	City	State
China	Ruijin Hospital, Medical School of Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	the mortality of the subjects within 28 days since the diagnosis of COVID-19	28 days since the diagnosis of COVID-19