Pulmonary Inflammation in COVID-19 ARDS | NCT04935450

Studies
Pulmonary Inflammation in COVID-19 ARDS

NCT04935450

Sponsor

Hospital Universitario Ramon y Cajal

Status

Unknown status

Last Update Posted

Jun 23, 2021Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19 Acute Respiratory Distress Syndrome

Interventions

Bronchoalveolar lavage

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2020Actual

Primary Completion Date

Aug 15, 2021Estimated

Completion Date

Aug 16, 2021Estimated

First Submitted Date

Jun 21, 2021

First Submission Date that Met QC Criteria

Jun 21, 2021

First Posted Date

Jun 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2021

Last Update Posted Date

Jun 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tommaso Bardi, Principal Investigator, Hospital Universitario Ramon y CajalPrincipal Investigator

Lead Sponsor

Hospital Universitario Ramon y CajalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bronchoalveolar lavage	Diagnostic 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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Correlation of BALF and Blood mediators with ICU mortality	Up to 3 months

Secondary Outcomes

Measure	Description	Time Frame
Respiratory mechanics	Correlation of BALF and Blood mediators with respiratory mechanics during invasive mechanical ventilation	Day 0 (after study inclusion) and every day up to 3 months
BALF PCR

Other Outcomes

Measure	Description	Time Frame
Hospital Mortality	Mortality in hospital	Up to 3 months
Health related quality of life via SF-36 questionnaire		Up to 3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years old
COVID-19 related ARDS
Hospitalized in ICU
Invasive mechanical ventilation

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

COVID-19 ARDS ICU patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
TOMMASO BARDI, MD	Contact	+34640350484		tommaso.bardi@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Ramon y Cajal	Recruiting	Madrid		28020	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D011014	Pneumonia

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

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Browse Branches

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