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

NCT05532852 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 728

Last updated 2022-09-08

No results posted yet for this study

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

Interventions

DRUG

standard-of-care plus Paxlovid

standard-of-care plus Paxlovid

DRUG

standard-of-care

standard-of-care

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Jieming Qu · Rui-jin Hospital, Shanghai Jiao-tong University School of Medicine, Shanghai,

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-06-30
Completion
2023-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532852 on ClinicalTrials.gov