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

NCT05532852 | Unknown

• 1 other identifier: KY01004
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

standard-of-care

SHAM COMPARATOR

Drug: standard-of-care

standard-of-care plus Paxlovid

EXPERIMENTAL

Drug: standard-of-care plus Paxlovid

Interventions

standard-of-care plus Paxlovid DRUG

standard-of-care plus Paxlovid

standard-of-care plus Paxlovid

standard-of-care DRUG

standard-of-care

standard-of-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed COVID-19 who had taken more than one dose of Paxlovid.

You may not qualify if:

• Age \< 18 years-old;
• Pregnancy;
• Data missing \> 20%.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Medical School of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Interventions

Standard of Care; nirmatrelvir and ritonavir drug combination

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jieming Qu

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieming Qu, PhD

CONTACT

+862164370045; jmqu0906@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 8, 2022
• Study Start: July 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)