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

COVID-19 is currently one of the serious public health challenges worldwide, and there isa great need to develop effective treatments. Paxlovid is a Pfizer-developed oral newdrug for the treatment of COVID-19. Paxlovid, which is used to treat adult patients withmild 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 2021and February 2022, respectively. Clinical trials have shown that this drug cansignificantly reduce the progression from mild to severe disease and the rate ofhospitalization and mortality. However, due to the limitations of clinical trials in thesubject selection, there is still insufficient knowledge about the efficacy and safety ofPaxlovid 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 wasdesigned to investigate the efficacy and safety of Paxlovid on sufferers of COVID-19through a retrospective, real-world analysis.

Detailed Description

Not Provided

Unknown status
COVID-19 Pneumonia

Drug: standard-of-care plus Paxlovid

standard-of-care plus Paxlovid

Drug: standard-of-care

standard-of-care

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%.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai, China

Investigator: Jieming Qu, MD, PhD
Contact: 86-21-64370045
jmqu0906@163.com

Contacts

Jieming Qu, PhD
+862164370045
jmqu0906@163.com

Jieming Qu, Principal Investigator
Rui-jin Hospital, Shanghai Jiao-tong University School of Medicine, Shanghai,

Ruijin Hospital
NCT Number
MeSH Terms
COVID-19
Nirmatrelvir and ritonavir drug combination