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

Recruiting

• Conditions: COVID-19
• Interventions: Drug: Paxlovid

• Registration Number: NCT05387369
• Lead Sponsor: Huashan Hospital

Brief Summary

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.

Study Timeline

• Study Start: 2022-03-21
• Status Verified: 2022-05
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-23
• Last Update Submitted: 2022-05-23
• Study First Posted: 2022-05-24
• Last Update Posted: 2022-05-24
• Primary Completion: 2023-03-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paxlovid	Paxlovid	Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive Paxlovid therapy

Primary Outcome Measures

Name	Time	Method
Viral shedding time	up to 28 days	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).
Percentage of the participants who have progression of COVID-19	up to 28 days	Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Huashan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, China