NCT05933291

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 24, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
Last Updated

July 6, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

June 2, 2023

Last Update Submit

July 5, 2023

Conditions

ARDS: Acute Respiratory Distress SyndromeCovid19

Outcome Measures

Primary Outcomes (2)

  • single-cell analysis in BALF before treatment

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

    before treatment in ICU

  • single-cell analysis in BALF after treatment

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

    After treatment in ICU for 1-4 weeks

Study Arms (4)

COVID-19 with steroid

COVID-19 ARDS patients with steroid treatment

Drug: steroid

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

non-COVID-19 without steroid

non-COVID-19 ARDS patients without steroid treatment

Interventions

steroidDRUG

Moderate- or high-dose steroids

COVID-19 with steroidnon-COVID-19 with steroid

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

4 COVID-19 ARDS patients, 4 non-COVID-19 ARDS patients

You may qualify if:

  • Severe ARDS patients

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

BALF

MeSH Terms

Conditions

Acute Lung InjuryCOVID-19

Interventions

Steroids

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yun Long, MD

    Peking union medical college hospital, ICU department

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2023

First Posted

July 6, 2023

Study Start

September 24, 2022

Primary Completion

February 9, 2023

Study Completion

March 15, 2023

Last Updated

July 6, 2023

Record last verified: 2023-06

Locations

CN(1)