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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: COVID-19 Pneumonia

Treatments: Drug: standard-of-care plus Paxlovid; Drug: standard-of-care

Study type: Interventional

Funder types: Other

Identifiers

NCT05532852

KY01004

Details and patient eligibility

About

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.

Enrollment: 728 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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728 participants in 2 patient groups

standard-of-care

Sham Comparator group

Treatment:

Drug: standard-of-care

standard-of-care plus Paxlovid

Experimental group

Treatment:

Drug: standard-of-care plus Paxlovid