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

NCT ID: NCT04505605

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-14
• Study Completion Date: 2021-10-18

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.

Conditions

Community-acquired Pneumonia; Covid19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient hospitalized without being transferred in the ICU

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.

Blood samples

Intervention Type: OTHER

A blood sample will be collected on a dry tube with 5mL separating gel on each enrolled patients. Those will be made depending on the patients hospitalization.

Patient directly hospitalized in the ICU

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.

Blood samples

Intervention Type: OTHER

A blood sample will be collected on a dry tube with 5mL separating gel on each enrolled patients. Those will be made depending on the patients hospitalization.

Patient transferred from an other hospital service to the ICU

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.

Blood samples

Intervention Type: OTHER

A blood sample will be collected on a dry tube with 5mL separating gel on each enrolled patients. Those will be made depending on the patients hospitalization.

Interventions

Blood samples

A blood sample will be collected on a dry tube with 5mL separating gel on each enrolled patients. Those will be made depending on the patients hospitalization.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Victor Dupouy

OTHER

Sponsor Role: collaborator

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François PHILIPPART, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Centre Hospitalier Victor Dupouy

Argenteuil, , France

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

LPSARS2

Identifier Type: -

Identifier Source: org_study_id