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

January 2, 2023 updated by: wang kaifei, Chinese PLA General Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

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
    • Beijign
      • Beijing, Beijign, China, 100000

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe COVID-19 infection after endotracheal intubation

Description

Inclusion Criteria:

  • 1) Respiratory distress, respiratory rate ≥ 30 times/minute

    2) At rest, oxygen saturation ≤ 93%

    3）PaO2/FiO2 ≤300mmHg

    4) Shock

    5) Respiratory failure requires mechanical ventilation

    6) Complicated with other organ failure requires ICU monitoring and treatment

    7) 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

    2) Age<18

    3) Mental disorders

    4) Patients with long-term mechanical ventilation for more than 60 days

    5) Disagreement group researcher

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death
Time Frame: 28 day
mortality
28 day

Collaborators and Investigators

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

Sponsor

Chinese PLA General Hospital

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)

December 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Estimate)

January 4, 2023

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Respiratory microecology

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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