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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05532852
Enrollment
728
Registered
2022-09-08
Start date
2022-07-01
Completion date
2023-10-31
Last updated
2022-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia

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.

Interventions

DRUGstandard-of-care plus Paxlovid

standard-of-care plus Paxlovid

DRUGstandard-of-care

standard-of-care

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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%.

Design outcomes

Primary

MeasureTime frameDescription
28-day mortality28 days since the diagnosis of COVID-19the mortality of the subjects within 28 days since the diagnosis of COVID-19

Countries

China

Contacts

Primary ContactJieming Qu, PhD
jmqu0906@163.com+862164370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026