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

Sponsor
Huashan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05387369
Collaborator
(none)
2,000
Enrollment
1
Location
60.3
Anticipated Duration (Months)
33.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19
Actual Study Start Date :
Mar 21, 2022
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
Mar 30, 2027

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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

  1. AEs and SAEs through Day 28 [up to 28 days]

    Adverse events and Serious adverse events through Day 28

  2. 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

  3. Time to sustained clinical recovery [up to 28 days]

    Time to sustained clinical recovery

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huashan Hospital Affiliated to Fudan University Shanghai China

Sponsors and Collaborators

  • Huashan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiming Zhang, Professor, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT05387369
Other Study ID Numbers:
  • KY2022-552
First Posted:
May 24, 2022
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jiming Zhang, Professor, Huashan Hospital
paxlovid
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of May 24, 2022