The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single-cell Landscape of BALF in Patients With Severe ARDS and CARDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05933291
Recruitment Status : Completed
First Posted : July 6, 2023
Last Update Posted : July 6, 2023
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The goal of this observational study is to learn about the effect of steroid therapy in patients with COVID-19 ARDS. The main questions it aims to answer are:

  • Differences between patients with COVID-19 ARDS before and after steroid treatment in BALF single cell landscape, as well as patients with different prognosis.
  • Differences between COVID-19 and non COVID-19 ARDS patients in BALF single cell landscape.

Participants will Choose whether to use or not to utilize steroid treatment based on conditions.


Condition or disease Intervention/treatment
ARDS: Acute Respiratory Distress Syndrome Covid19 Drug: steroid

Detailed Description:
Collect BALF from COVID-19 and non-COVID-19 ARDS patients both before and during remission, then perform single-cell sequencing.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Single-cell Landscape of BALF in Patients With Severe ARDS and CARDS: an Analysis of the Effectiveness of Steroid Therapy and a Comparison Between COVID-19 ARDS and ARDS From Other Etiologies
Actual Study Start Date : September 24, 2022
Actual Primary Completion Date : February 9, 2023
Actual Study Completion Date : March 15, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
COVID-19 with steroid
COVID-19 ARDS patients with steroid treatment
 Drug: steroid
Moderate- or high-dose steroids
COVID-19 without steroid
COVID-19 ARDS patients without steroid treatment
non-COVID-19 with steroid
non-COVID-19 ARDS patients with steroid treatment
 Drug: steroid
Moderate- or high-dose steroids
non-COVID-19 without steroid
non-COVID-19 ARDS patients without steroid treatment


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. single-cell analysis in BALF before treatment [ Time Frame: before treatment in ICU ]
    collect BALF before and during treatment and perform single-cell sequencing

  2. single-cell analysis in BALF after treatment [ Time Frame: After treatment in ICU for 1-4 weeks ]
    collect BALF before and during treatment and perform single-cell sequencing


Biospecimen Retention:   Samples With DNA
BALF

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
4 COVID-19 ARDS patients, 4 non-COVID-19 ARDS patients
Criteria

Inclusion Criteria:

  • Severe ARDS patients

Exclusion Criteria:

  • None
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05933291


Locations
Layout table for location information
China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Layout table for investigator information
Study Director: Yun Long, MD Peking union medical college hospital, ICU department
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT05933291    
Other Study ID Numbers: Covid20230601
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: July 6, 2023
Last Verified: June 2023
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury