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

Not Applicable

Recruiting

• Conditions: COVID-19 Pneumonia
• Interventions: Drug: standard-of-care plus Paxlovid; Drug: standard-of-care

• Registration Number: NCT05532852
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Last Update Submitted: 2022-09-06
• Study First Posted: 2022-09-08
• Last Update Posted: 2022-09-08
• Primary Completion: 2023-06
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 728

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard-of-care plus Paxlovid	standard-of-care plus Paxlovid	-
standard-of-care	standard-of-care	-

Primary Outcome Measures

Name	Time	Method
28-day mortality	28 days since the diagnosis of COVID-19	the mortality of the subjects within 28 days since the diagnosis of COVID-19

Trial Locations

Locations (1)

Ruijin Hospital, Medical School of Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China