Pulmonary Inflammation in COVID-19 ARDS

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

• Registration Number: NCT04935450
• Lead Sponsor: Hospital Universitario Ramon y Cajal

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.

Study Timeline

• Study Start: 2020-12-12
• Status Verified: 2021-06
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Study First Posted: 2021-06-23
• Last Update Posted: 2021-06-23
• Primary Completion: 2021-08-15
• Study Completion: 2021-08-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Up to 3 months	Correlation of BALF and Blood mediators with ICU mortality

Secondary Outcome Measures

Name	Time	Method
BALF PCR	Day 0 (performance of first BALF sample) Day 8, Day 16	Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid, comparison with contemporary PCR in Blood
BALF characteristics	Day 0 (performance of first BALF sample) Day 8, Day 16	Cellular populations in BALF and their change over time
BALF cytoquines	Day 0 (performance of first BALF sample) Day 8, Day 16	Cytoquines in BALF and change over time
Respiratory mechanics	Day 0 (after study inclusion) and every day up to 3 months	Correlation of BALF and Blood mediators with respiratory mechanics during invasive mechanical ventilation

Trial Locations

Locations (1)

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain