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A Registry Study of Patients Hospitalized With Confirmed COVID-19

Sponsor
Beijing Chao Yang Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05792865
Collaborator
(none)
488
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The design of this registered study aims to evaluate the efficacy and safety of Paxlovid in the treatment of hospitalized COVID-19 patients, and to explore factors related to the efficacy and safety of Paxlovid.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
488 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
A Registry Study of Patients Hospitalized With Confirmed COVID-19
Anticipated Study Start Date :
Mar 30, 2023
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Paxlovid（Within 5 days after the diagnosis of COVID-19）

According to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID is within 5 days.

Drug: paxlovid
Patients treated with PAXLOVID within 5 days of being diagnosed with covid-19 will be included in this group. Patients treated with PAXLOVID will be included in this group. This study is a non-interventional observational study, and no intervention measures were applied to the clinical diagnosis and treatment process of hospitalized COVID-19 patients. The use of Paxlovid is completely decided by the clinical doctors based on the patients' condition and clinical experience.
Other Names:
  • paxlovid within initial 5 days

    		•
    Paxlovid （More than 5 days after the diagnosis of COVID-19）

    According to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID exceeds 5 days.

    Drug: Paxlovid
    Patients treated with PAXLOVID outside of the initial 5 days after being diagnosed with covid-19 will be included in this group.
    Other Names:
  • Paxlovid outside of the initial 5 days

    		•
    No paxlovid used

    Patients have never used Paxlovid after being diagnosed with COVID-19, whether before or after hospitalization.

    Drug: No paxlovid
    Patients not treated with PAXLOVID will be included in this group. This study is a non-interventional observational study, and no intervention measures were applied to the clinical diagnosis and treatment process of hospitalized COVID-19 patients. The use of Paxlovid is completely decided by the clinical doctors based on the patients' condition and clinical experience.

    Outcome Measures

    Primary Outcome Measures

    1. Disease progression rates [up to 28 days]

      The proportion of patients who experienced any of the following events within 28 days after being diagnosed with COVID-19, including all-cause mortality, requiring invasive mechanical ventilation, or being admitted to the intensive care unit.

    Secondary Outcome Measures

    1. all-cause deaths rates [up to 28 days]

      The proportion of patients who experienced all-cause mortality within 28 days after being diagnosed with COVID-19.

    2. rehospitalization event rates [up to 28 days]

      The proportion of patients who experienced a rehospitalization event within 28 days after being diagnosed with COVID-19

    3. COVID-19 repositive event rates [up to 28 days]

      The proportion of patients who experienced a COVID-19 repositive event within 28 days after being diagnosed with COVID-19

    4. adverse drug reaction event [up to 28 days]

      The proportion of patients who experienced any adverse drug reaction events within 28 days after being diagnosed with COVID-19.

    5. thromboembolic event rates [up to 28 days]

      The proportion of patients who experienced thromboembolic events, including deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction, within 28 days after being diagnosed with COVID-19.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Confirmed diagnosis of COVID-19 infection.

    2. Presence of at least one high-risk factor, including age ≥60 years, diabetes, hypertension, cardiovascular disease, stroke, chronic liver or kidney disease, cancer, history of smoking or obesity.

    Exclusion Criteria:
    • No specific exclusion criteria in this study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Beijing Chao Yang Hospital

    Investigators

    • Principal Investigator: Yi Zhang, PhD, Beijing Chao Yang Hospital
    • Principal Investigator: Zhuoling An, PhD, Beijing Chao Yang Hospital
    • Principal Investigator: Chaohui Tong, PhD, Beijing Chao Yang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhang Yi, professer, Beijing Chao Yang Hospital
    ClinicalTrials.gov Identifier:
    NCT05792865
    Other Study ID Numbers:
    • CYH-PHARM1
    First Posted:
    Mar 31, 2023
    Last Update Posted:
    Mar 31, 2023
    Last Verified:
    Mar 1, 2023
    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 Zhang Yi, professer, Beijing Chao Yang Hospital
    Hospitalized
    paxlovid
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Mar 31, 2023