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

NCT ID: NCT05532852

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 728 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-10-31

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.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard-of-care

Group Type: SHAM_COMPARATOR

standard-of-care

Intervention Type: DRUG

standard-of-care

standard-of-care plus Paxlovid

Group Type: EXPERIMENTAL

standard-of-care plus Paxlovid

Intervention Type: DRUG

standard-of-care plus Paxlovid

Interventions

standard-of-care plus Paxlovid

standard-of-care plus Paxlovid

Intervention Type: DRUG

standard-of-care

standard-of-care

Intervention Type: DRUG

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%.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jieming QU

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jieming Qu

Role: PRINCIPAL_INVESTIGATOR

Rui-jin Hospital, Shanghai Jiao-tong University School of Medicine, Shanghai,

Locations

Ruijin Hospital, Medical School of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jieming Qu, PhD

Role: CONTACT

jmqu0906@163.com

+862164370045

Facility Contacts

Jieming Qu, MD, PhD

Role: primary

jmqu0906@163.com

86-21-64370045

Other Identifiers

KY01004

Identifier Type: -

Identifier Source: org_study_id