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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05933291
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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	Phase
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

• 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: Sep 24, 2022
• Actual Primary Completion Date: Feb 9, 2023
• Actual Study Completion Date: Mar 15, 2023

Arms and Interventions

Arm	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

Primary Outcome Measures

1. single-cell analysis in BALF before treatment [before treatment in ICU]

   collect BALF before and during treatment and perform single-cell sequencing

2. single-cell analysis in BALF after treatment [After treatment in ICU for 1-4 weeks]

   collect BALF before and during treatment and perform single-cell sequencing

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Severe ARDS patients

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

• Study Director: Yun Long, MD, Peking union medical college hospital, ICU department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT05933291
• Other Study ID Numbers: Covid20230601
• First Posted: Jul 6, 2023
• Last Update Posted: Jul 6, 2023
• Last Verified: Jun 1, 2023

• Additional relevant MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury

Study Results

No Results Posted as of Jul 6, 2023