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

NCT04505605 | Terminated

• 1 other identifier: LPSARS2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Community-acquired Pneumonia; Covid19

Keywords

covid19; pneumonia; community acquired pneumonia; biomarkers

Outcome Measures

Primary Outcomes (1)

• Evaluation of the dosage of biomarkers

  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.

  6 months = study duration

Secondary Outcomes (1)

• Link between the biomarkers

  6 months = study duration

Study Arms (3)

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.

Other: Blood samples

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.

Other: Blood samples

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.

Other: Blood samples

Interventions

Blood samples 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; Patient hospitalized without being transferred in the ICU; Patient transferred from an other hospital service to the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient aged from 18 years, infected by the COVID-19 and suffers from a severe form of COVID 19 acquired pneumonia that requires an hospitalization.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Centre Hospitalier Victor Dupouy: collaborator

Study Sites (2)

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples on a dry tube with 5mL separating gel are collected, depending on patient hospitalization procedure.

MeSH Terms

Conditions

Community-Acquired Pneumonia; COVID-19; Pneumonia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• François PHILIPPART, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 10, 2020
• Study Start: May 14, 2020
• Primary Completion: October 18, 2021
• Study Completion: October 18, 2021
• Last Updated: January 18, 2022

Record last verified: 2021-12

Locations

FR (2)