Study of a Possible Respiratory Degradation Prognosis Caused by Biomarkers in Severe Forms of COVID-19 Pneumonia

Terminated

• Conditions: Community-acquired Pneumonia; Covid19
• Interventions: Other: Blood samples

• Registration Number: NCT04505605
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe forms, it may require a mechanical ventilation or even lead to an acute respiratory distress syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-stranded RNA virus of positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2 is responsible for the third epidemic in less than twenty years secondary to a Coronavirus (SARS-CoV then MERS-CoV) and if the mortality associated with it is lower than that of previous strains, particularly MERS-CoV (Middle East Respiratory Syndrome), its spread is considerably bigger. As a result, the number of patients developing respiratory distress that require an invasive mechanical ventilation is high, with prolonged ventilation duration in these situations.

Detailed Description

The mechanisms responsible for alveolar damage during viral pathologies, particularly Coronavirus, are very similar to those observed during acute respiratory distress syndromes in adults. Macrophages present in the pulmonary parenchyma appear to play a central role in the severity of the inflammatory response and the production of proinflammatory mediators, notably chemokines leading to secondary leukocyte infiltration. The recent monocytic origin could explain the particular severity of this inflammatory response whose usual control is no longer assured. The alteration of infectious control by alveolar macrophages during ageing also tends to confirm the central role of these cells in the pattern of respiratory distress observed during COVID-19 infection, which is particularly severe in the elderly.

In many situations, the endotoxin (or lipopolysaccharide, LPS) plays a major role in the pathophysiology and even the severity of respiratory damage, in particular, due to the existence of circulating endotoxin from the pathogenic agent responsible (Gram-negative bacteria), but also due to translocation of digestive origin in the context of sepsis (systemic inflammatory response) which is associated with (if not responsible for) respiratory aggression. Such an alteration of the mucous membrane is particularly noticeable in cases of obesity. The importance of this mechanism during pulmonary aggression of viral origin is, on the other hand, unknown.

Few data are available on the prediction of early onset of respiratory distress syndrome in low respiratory infection in the absence of mechanical ventilation.

Study Timeline

• Study Start: 2020-05-14
• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-10
• Primary Completion: 2021-10-18
• Study Completion: 2021-10-18
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient aged from 18 years old
• French-speaking patient
• Patient whose COVID-19 respiratory infection was confirmed by laboratory tests (either by a PCR and any other commercial or public health tests) or a scanner, that requires a hospitalization in a healthcare institution.

Exclusion Criteria

• Patient/ relative or proxy person opposed to the study participation
• Patient under guardianship or curators
• Patient deprived of liberty
• Patient under the safeguard of justice.
• Dying / Moribund patient
• Pregnant or breastfeeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient hospitalized without being transferred in the ICU	Blood samples	A blood sample on a dry tube with 5 ml separating gel in addition to the blood test made on the basis of the usual medical care, will be taken on D1 (day of the enrollment = the day of hospitalization in the healthcare institution). The total volume of blood collected as part of the research is therefore 5 ml.
Patient transferred from an other hospital service to the ICU	Blood samples	A blood sample on a dry tube with 5 ml separating gel in addition to the blood test that will be taken at D1 and D3 of the patient's admission to the intensive care unit, even if it has already been included in the study during the patient's admission to the unit (D1 hospitalization). The total volume of blood collected for the research is therefore 15 ml.
Patient directly hospitalized in the ICU	Blood samples	A blood sample on a dry tube with a 5 ml separating gel in addition to the blood test made on the basis of the usual medical care, will be taken on D1 and D3 of the admission to intensive care. The total volume of blood collected for research is therefore 10 ml.

Primary Outcome Measures

Name	Time	Method
Evaluation of the dosage of biomarkers	6 months = study duration	The study aims at evaluating the interests of the biomarkers dosage: endotoxin (LPS) and circulating cytokines (HMGB1 or RAGE) in the prediction of respiratory degradation through a severe form of COVID-19 acquired pneumonia that requires a hospitalization.

Secondary Outcome Measures

Name	Time	Method
Link between the biomarkers	6 months = study duration	The study will be also focusing on the search for a correlation between the biomarkers by blood samples that will be taken on each hospitalized patients.

Trial Locations

Locations (2)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, Ile De France, France

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil, France