ARDS: Acute Respiratory Distress SyndromeNCT05933291
Single-cell Landscape of BALF in Patients With Severe ARDS and CARDS
An observational study of ARDS: Acute Respiratory Distress Syndrome and Covid19, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ARDS: Acute Respiratory Distress Syndrome, Covid19
- What is being tested?
- steroid
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2022to 15 Mar 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: 4 COVID-19 ARDS patients, 4 non-COVID-19 ARDS patients
Who may be able to join
- Severe ARDS patients
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
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
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.
Read the detailed description
Collect BALF from COVID-19 and non-COVID-19 ARDS patients both before and during remission, then perform single-cell sequencing.
- Conditions
- ARDS: Acute Respiratory Distress Syndrome, Covid19
- Being tested
- steroid
- Medical subject headings
- Acute Lung Injury, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroidDrug
Moderate- or high-dose steroids
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 with steroid | COVID-19 ARDS patients with steroid treatment Receives: 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 Receives: Drug: steroid | |
| non-COVID-19 without steroid | non-COVID-19 ARDS patients without steroid treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
single-cell analysis in BALF before treatment
collect BALF before and during treatment and perform single-cell sequencing
Measured: before treatment in ICU
single-cell analysis in BALF after treatment
collect BALF before and during treatment and perform single-cell sequencing
Measured: After treatment in ICU for 1-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start24 Sep 2022
- Primary completion9 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS: Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Long, MD, Study director, Peking union medical college hospital, ICU department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933291
- Sponsor's protocol ID
- Covid20230601
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05933291
- Acronym / sponsor ID
- Covid20230601
- Conditions
- ARDS: Acute Respiratory Distress Syndrome, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 Sep 2022 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 6 Jul 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 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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COVID-19 with steroid | – | Drug: steroidCOVID-19 ARDS patients with steroid treatment |
| COVID-19 without steroid | – | –COVID-19 ARDS patients without steroid treatment |
| non-COVID-19 with steroid | – | Drug: steroidnon-COVID-19 ARDS patients with steroid treatment |
| non-COVID-19 without steroid | – | –non-COVID-19 ARDS patients without steroid treatment |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 4 COVID-19 ARDS patients, 4 non-COVID-19 ARDS patients
Key inclusion criteria (1 listed)
- Severe ARDS patients
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steroidModerate- or high-dose steroids | Drug | COVID-19 with steroid, non-COVID-19 with steroid |
Primary outcome
single-cell analysis in BALF before treatment
Time frame: before treatment in ICU
collect BALF before and during treatment and perform single-cell sequencing
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 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.
Yun Long, MD study director
Peking union medical college hospital, ICU department
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 ARDS: Acute Respiratory Distress Syndrome and Covid19, run by Peking Union Medical College 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
single-cell analysis in BALF before treatment (time frame: before treatment in ICU). The study lists 2 primary outcomes in all. 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 6 Jul 2023.