Microbiome,Immune Function, Critically IllNCT05670275
Microecology and Host Immunity in Patients With Severe COVID-19 Infection
An observational study of Microbiome,Immune Function, Critically Ill, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Microbiome,Immune Function, Critically Ill
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients with severe COVID-19 infection after endotracheal intubation
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PLA
Beijing, Beijign, 100000
Lin Wang, doctor, 15822048750, wl1194079931@163.com
About this study
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.
Read the 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.
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
death
mortality
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Dec 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiome,Immune Function, Critically IllStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670275
- Sponsor's protocol ID
- Respiratory microecology
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microecology and Host Immunity in Patients With Severe COVID-19 Infection
- ClinicalTrials.gov ID
- NCT05670275
- Acronym / sponsor ID
- Respiratory microecology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with severe COVID-19 infection after endotracheal intubation
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death
Time frame: 28 day
mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbiome,Immune Function, Critically Ill, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Wang, doctor (15822048750, wl1194079931@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 28 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.