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

  • STATUS
    Recruiting
  • End date
    Oct 20, 2023
  • participants needed
    728
  • sponsor
    Ruijin Hospital
Updated on 7 October 2022

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.

Details
Condition COVID-19 Pneumonia
Treatment Standard-of-Care, standard-of-care plus Paxlovid
Clinical Study IdentifierNCT05532852
SponsorRuijin Hospital
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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%
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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