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

May 23, 2022 updated by: Jiming Zhang, Huashan Hospital
The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Huashan Hospital affiliated to Fudan University
        • Contact:
        • Principal Investigator:
          • Jiming Zhang, PhD
        • Principal Investigator:
          • Feng Sun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with COVID-19 who were admitted to Huashan Hospital, Fudan University from 2022 to 2027

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Paxlovid
Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive Paxlovid therapy
Drug: Paxlovid
The study is a real-world study. According to the actual medical history of patients, the usage of paxlovid will be collected.
Routine therapy
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral shedding time
Time Frame: 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).
up to 28 days
Percentage of the participants who have progression of COVID-19
Time Frame: 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
up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AEs and SAEs through Day 28
Time Frame: up to 28 days
Adverse events and Serious adverse events through Day 28
up to 28 days
Percentage of participants who turned negative for SARS-CoV-2
Time Frame: up to 28 days
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 Frame: up to 28 days
Time to sustained clinical recovery
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Feng Sun, MD, Huashan Hospital affliatied to Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Anticipated)

March 30, 2023

Study Completion (Anticipated)

March 30, 2027

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2022-552

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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