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NCT05387369 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05387369
Other study ID # KY2022-552
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 21, 2022
Est. completion date March 30, 2027

Study information
Verified date May 2022
Source Huashan Hospital
Contact Feng Sun, MD
Phone +86 02152889999
Email aaronsf1125@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date March 30, 2027
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Paxlovid
The study is a real-world study. According to the actual medical history of patients, the usage of paxlovid will be collected.

Locations
Country Name City State
China Huashan Hospital Affiliated to Fudan University Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 AEs and SAEs through Day 28 Adverse events and Serious adverse events through Day 28 up to 28 days
Secondary 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
Secondary Time to sustained clinical recovery Time to sustained clinical recovery up to 28 days
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