A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19

Study Overview
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Brief Summary
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The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.

Detailed Description
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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.

Official Title
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A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Paxlovid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paxlovid<br>Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive Paxlovid therapy | Drug: Paxlovid<br>* The study is a real-world study. According to the actual medical history of patients, the usage of paxlovid will be collected.<br>|
| Routine therapy<br>Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive routine therapy without paxlovid | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral shedding time | time from the first positive testing to the first day of nucleic acid Ct value> 35 for both ORF1ab and N gene (in two consecutive). | up to 28 days | 
| Percentage of the participants who have progression of COVID-19 | Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs and SAEs through Day 28 | Adverse events and Serious adverse events through Day 28 | up to 28 days | 
| Percentage of participants who turned negative for SARS-CoV-2 | Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14 | up to 28 days | 
| Time to sustained clinical recovery | Time to sustained clinical recovery | up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paxlovid