A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paxlovid.
- Who it may be relevant to
- Registry conditions: COVID-19. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.
Detailed description
The study is a real-world study and the case records of patients with COVID-19 who visit Huashan Hospital affiliated to Fudan University from 2022 to 2027 and receive Paxlovid therapy will be collected in this study. The medical data including patient demographic, clinical characteristics, laboratory examination, history of treatments, adverse reactions and treatment outcome will be extracted to analyze the effectivity and safety of paxlovid and explore the prognosis-relevant factors of COVID-19.
Interventions
- Drug Paxlovid
The study is a real-world study. According to the actual medical history of patients, the usage of paxlovid will be collected.
Primary outcome measures
- Viral shedding time [Time frame: up to 28 days]
- Percentage of the participants who have progression of COVID-19 [Time frame: up to 28 days]
Secondary outcome measures (3)
- AEs and SAEs through Day 28 [Time frame: up to 28 days]
- Percentage of participants who turned negative for SARS-CoV-2 [Time frame: up to 28 days]
- Time to sustained clinical recovery [Time frame: up to 28 days]
Eligibility criteria
Inclusion criteria
- Participants who have a positive SARS-CoV-2 test result;
- Participants who have one or more mild or moderate COVID-19 symptoms.
Exclusion criteria
- No specific exclusion criteria in this real world study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Huashan Hospital Affiliated to Fudan University — Shanghai
Identifiers
NCT: NCT05387369 · KY2022-552