NCT05670275

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 2, 2023

Last Update Submit

January 2, 2023

Conditions

Microbiome,Immune Function, Critically Ill

Outcome Measures

Primary Outcomes (1)

  • death

    mortality

    28 day

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe COVID-19 infection after endotracheal intubation

You may qualify if:

  • \) Respiratory distress, respiratory rate ≥ 30 times/minute
  • \) At rest, oxygen saturation ≤ 93%
  • ）PaO2/FiO2 ≤300mmHg
  • \) Shock
  • \) Respiratory failure requires mechanical ventilation
  • \) Complicated with other organ failure requires ICU monitoring and treatment
  • \) 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)

You may not qualify if:

  • \) Pregnant women
  • \) Age\<18
  • \) Mental disorders
  • \) Patients with long-term mechanical ventilation for more than 60 days
  • \) Disagreement group researcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA

Beijing, Beijign, 100000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

bronchoalveolar lavage specimens

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Lin Wang, doctor

CONTACT

15822048750wl1194079931@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chinese PLA General Hospital

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

December 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations

CN(1)