A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19
1 other identifier
observational
2,000
1 country
1
Brief Summary
The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2022
CompletedFirst Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2027
ExpectedMay 24, 2022
May 1, 2022
1 year
May 23, 2022
May 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
AEs and SAEs through Day 28
up to 28 days
Percentage of participants who turned negative for SARS-CoV-2
up to 28 days
Time to sustained clinical recovery
up to 28 days
Study Arms (2)
Paxlovid
Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive Paxlovid therapy
Routine therapy
Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive routine therapy without paxlovid
Interventions
The study is a real-world study. According to the actual medical history of patients, the usage of paxlovid will be collected.
Eligibility Criteria
Patients with COVID-19 who were admitted to Huashan Hospital, Fudan University from 2022 to 2027
You may qualify if:
- Participants who have a positive SARS-CoV-2 test result;
- Participants who have one or more mild or moderate COVID-19 symptoms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Study Sites (1)
Huashan Hospital Affiliated to Fudan University
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Feng Sun, MD
Huashan Hospital affliatied to Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 23, 2022
First Posted
May 24, 2022
Study Start
March 21, 2022
Primary Completion
March 30, 2023
Study Completion (Estimated)
March 30, 2027
Last Updated
May 24, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share