Pulmonary Inflammation in COVID-19 ARDS (IMPU-COVID)

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19 Acute Respiratory Distress Syndrome; ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
• Intervention / Treatment: Diagnostic test: Bronchoalveolar lavage

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 Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: TOMMASO BARDI, MD; Phone Number: +34640350484; Email: tommaso.bardi@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28020
    • Recruiting
    • Hospital Universitario Ramon Y Cajal
    • Contact: TOMMASO BARDI, MD; Phone Number: +34640350484; Email: tommaso.bardi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COVID-19 ARDS ICU patients

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid, comparison with contemporary PCR in Blood	Day 0 (performance of first BALF sample) Day 8, Day 16
BALF characteristics	Cellular populations in BALF and their change over time	Day 0 (performance of first BALF sample) Day 8, Day 16
BALF cytoquines	Cytoquines in BALF and change over time	Day 0 (performance of first BALF sample) Day 8, Day 16

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Anticipated): August 15, 2021
• Study Completion (Anticipated): August 16, 2021

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; ARDS; Mechanical Ventilation; Respiratory Mechanics; Pulmonary Inflammation; Broncho Alveolar Lavage
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Severe Acute Respiratory Syndrome; COVID-19; Syndrome; Inflammation; Pneumonia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: 398-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No