ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2IMPU-COVIDNCT04935450
Pulmonary Inflammation in COVID-19 ARDS
An observational study of ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 and COVID-19 Acute Respiratory Distress Syndrome, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
Patients older than 18 years of age, with COVID-19 related ARDS (C-ARDS) hospitalized in the ICU and invasively mechanically ventilated will be included in the study. This is an observational cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Bronchoalveolar lavage
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2020to 16 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 ARDS ICU patients
Who may be able to join
- Age > 18 years old
- COVID-19 related ARDS
- Hospitalized in ICU
- Invasive mechanical ventilation
Who cannot join
- Immunocompromised for previous condition
- transplanted patients
- Known pulmonary bacterial co-infection at the time of admission to the ICU
- Contraindication to the realization of Bronchoscopy (Itracranial Hypertension, severe hypoxaemia with P/F < 80, severe hemodynamic instability, severe arrhythmia, non correctable coagulopathy)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28020
TOMMASO BARDI, MD, +34640350484, tommaso.bardi@gmail.com
About this study
Official title: Pulmonary Inflammation Profiles in COVID-19 Related ARDS
Patients older than 18 years of age, with COVID-19 related ARDS (C-ARDS) hospitalized in the ICU and invasively mechanically ventilated will be included in the study.
This is an observational cohort study. After informed consent by the next of kin, and within the first 72 hours of invasive mechanical ventilation a blood and a Broncho Alveolar Lavage Fluid (BALF) sample will be collected. If the patients remain invasively mechanically ventilated a second and third blood and BALF sample will be collected every 7-10 days.
Read the detailed description
The main objective of the core study is to measure a number of biochemical, cellular and inflammatory mediators in the BALF of C-ARDS patients and evaluate their correlation with the course of disease in terms of respiratory mechanics, complications and outcomes.
The mediators selected have been previously used in ARDS investigation to attempt prognostic and predictive enrichment.
Patients hospitalized in the ICU following C-ARDS and requiring invasive mechanical ventilation will be candidates for enrollment.
Patients enrolled in the study (Informed consent obtained from next of kin) will be subject to the realization of optic bronchoscopy within the first 72 h of mechanical ventilation to obtain BALF for analysis. A second and third bronchoscopy and sampling of BALF will be performed every 7-10 days if mechanical ventilation and the clinical conditions allow it. A sample of whole blood will be taken contemporary to each bronchoscopy in order to perform parallel measurements (lungs and peripheral blood). Patients will be followed up until hospital discharge.
BALF samples will be divided to perform different analysis in the immunology, cytology and microbiology labs.
- Conditions
- ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19 Acute Respiratory Distress Syndrome
- Being tested
- Bronchoalveolar lavage
- Keywords
- ARDS, COVID-19, Broncho Alveolar Lavage, Pulmonary Inflammation, Mechanical Ventilation, Respiratory Mechanics
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar lavageDiagnostic test
Low volume Broncho alveolar lavage. During optic flexible bronchoscopy through the tracheal tube or the tracheostomy cannula a maximum of 4 aliquots of 20 ml normal saline will be instilled in a wedged position in the right medium lobe of the patients and then aspirated untill reaching a total of 25ml of fluid (BALF) for analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Correlation of BALF and Blood mediators with ICU mortality
Measured: Up to 3 months
Secondary outcomes (4)
Respiratory mechanics
Correlation of BALF and Blood mediators with respiratory mechanics during invasive mechanical ventilation
Measured: Day 0 (after study inclusion) and every day up to 3 months
BALF PCR
Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid, comparison with contemporary PCR in Blood
Measured: Day 0 (performance of first BALF sample) Day 8, Day 16
BALF characteristics
Cellular populations in BALF and their change over time
Measured: Day 0 (performance of first BALF sample) Day 8, Day 16
BALF cytoquines
Cytoquines in BALF and change over time
Measured: Day 0 (performance of first BALF sample) Day 8, Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start12 Dec 2020
- Primary completion15 Aug 2021 (estimated)
- Study completion16 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Bardi, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935450
- Sponsor's protocol ID
- 398-20
- Acronym
- IMPU-COVID
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Inflammation Profiles in COVID-19 Related ARDS
- ClinicalTrials.gov ID
- NCT04935450
- Acronym / sponsor ID
- IMPU-COVID / 398-20
- Conditions
- ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19 Acute Respiratory Distress Syndrome
- Keywords
- ARDS, COVID-19, Broncho Alveolar Lavage, Pulmonary Inflammation, Mechanical Ventilation, Respiratory Mechanics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 16 Aug 2021 (estimated)
- First posted
- 23 Jun 2021 (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.
Patients older than 18 years of age, with COVID-19 related ARDS (C-ARDS) hospitalized in the ICU and invasively mechanically ventilated will be included in the study.
This is an observational cohort study. After informed consent by the next of kin, and within the first 72 hours of invasive mechanical ventilation a blood and a Broncho Alveolar Lavage Fluid (BALF) sample will be collected. If the patients remain invasively mechanically ventilated a second and third blood and BALF sample will be collected every 7-10 days.
Detailed description
The main objective of the core study is to measure a number of biochemical, cellular and inflammatory mediators in the BALF of C-ARDS patients and evaluate their correlation with the course of disease in terms of respiratory mechanics, complications and outcomes.
The mediators selected have been previously used in ARDS investigation to attempt prognostic and predictive enrichment.
Patients hospitalized in the ICU following C-ARDS and requiring invasive mechanical ventilation will be candidates for enrollment.
Patients enrolled in the study (Informed consent obtained from next of kin) will be subject to the realization of optic bronchoscopy within the first 72 h of mechanical ventilation to obtain BALF for analysis. A second and third bronchoscopy and sampling of BALF will be performed every 7-10 days if mechanical ventilation and the clinical conditions allow it. A sample of whole blood will be taken contemporary to each bronchoscopy in order to perform parallel measurements (lungs and peripheral blood). Patients will be followed up until hospital discharge.
BALF samples will be divided to perform different analysis in the immunology, cytology and microbiology labs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 ARDS ICU patients
Key inclusion criteria (4 listed)
- Age > 18 years old
- COVID-19 related ARDS
- Hospitalized in ICU
- Invasive mechanical ventilation
Key exclusion criteria (4 listed)
- Immunocompromised for previous condition
- transplanted patients
- Known pulmonary bacterial co-infection at the time of admission to the ICU
- Contraindication to the realization of Bronchoscopy (Itracranial Hypertension, severe hypoxaemia with P/F < 80, severe hemodynamic instability, severe arrhythmia, non correctable coagulopathy)
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 |
|---|---|---|
| Bronchoalveolar lavageLow volume Broncho alveolar lavage. During optic flexible bronchoscopy through the tracheal tube or the tracheostomy cannula a maximum of 4 aliquots of 20 ml normal saline will be instilled in a wedged position in the right medium lobe of the patients and then aspirated untill reaching a total of 25ml of fluid (BALF) for analysis | Diagnostic test | – |
Primary outcome
Mortality
Time frame: Up to 3 months
Correlation of BALF and Blood mediators with ICU mortality
4 secondary outcomes
Respiratory mechanics
Time frame: Day 0 (after study inclusion) and every day up to 3 months
BALF PCR
Time frame: Day 0 (performance of first BALF sample) Day 8, Day 16
BALF characteristics
Time frame: Day 0 (performance of first BALF sample) Day 8, Day 16
BALF cytoquines
Time frame: Day 0 (performance of first BALF sample) Day 8, Day 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
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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 ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 and COVID-19 Acute Respiratory Distress Syndrome, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 4 inclusion and 4 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 23 Jun 2021. 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 Spain. 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 TOMMASO BARDI, MD (+34640350484, tommaso.bardi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Up to 3 months). 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 23 Jun 2021.