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Microecology and Host Immunity in Patients With Severe COVID-19 Infection

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05670275
Collaborator
(none)
200
Enrollment
1
Location
6
Anticipated Duration (Months)
33.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to analyze the relationship between the microbial community, host immunity and the prognosis of patients with severe COVID-19.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Methods: Bronchoalveolar lavage specimens of patients with severe COVID-19 were collected and studied to analyze the relationship between the composition of patients' microecology and the occurrence and development of disease.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Microecology and Host Immunity in Patients With Severe COVID-19 Infection
    Actual Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. death [28 day]

      mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
      1. Respiratory distress, respiratory rate ≥ 30 times/minute
    1. At rest, oxygen saturation ≤ 93%

    3）PaO2/FiO2 ≤300mmHg

    1. Shock

    2. Respiratory failure requires mechanical ventilation

    3. Complicated with other organ failure requires ICU monitoring and treatment

    4. Or in case of any of the following conditions, even if none of the above conditions is found, it is also managed as a critical case: ① pulmonary imaging shows that the lesion has significantly progressed more than 50% within 24-48 hours; ② Age>60 years old; ③ Complicated with serious chronic diseases (including diabetes, hypertension, coronary heart disease, malignant tumor, structural lung disease, pulmonary heart disease and immunosuppressed population)

    Exclusion Criteria:
      1. Pregnant women

    1. Age<18

    2. Mental disorders

    3. Patients with long-term mechanical ventilation for more than 60 days

    4. Disagreement group researcher

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PLA Beijing Beijign China 100000

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    wang kaifei, Chinese PLA General Hospital, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT05670275
    Other Study ID Numbers:
    • Respiratory microecology
    First Posted:
    Jan 4, 2023
    Last Update Posted:
    Jan 4, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of Jan 4, 2023