C5a Receptor Expression - COVID-19 (C5-COV)

Study Overview
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Brief Summary
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The pathophysiology of ARDS is linked to an uncontrolled inflammatory response at the level of alveolo-capillary membrane, mediated by neutrophils and mononuclear cells. The complement system and anaphylatoxin C5a have shown central role in the recruitment of these pro-inflammatory cells and more broadly in the genesis of cytokinic storm syndrome. C5a acts via receptors C5aR and C5L2. This is a preliminary study aimed at studying the expression of the C5a receptor on myeloid cells in peripheral blood of patients with ARDS secondary to COVID-19. This study has of primary objective to show there is an overexpression of the C5a receptor in patients with ARDS secondary to COVID-19 compared to control patients (patients with COVID-19 without respiratory distress and healthy volunteers). The medium-term objective is to develop a clinical trial to test the effectiveness of anti-C5aR antibody in this condition.

Detailed Description
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The pathophysiology of ARDS is linked to an uncontrolled inflammatory response at the level of alveolo-capillary membrane, mediated by neutrophils and mononuclear cells. The complement system and anaphylatoxin C5a have shown central role in the recruitment of these pro-inflammatory cells and more broadly in the genesis of cytokinic storm syndrome. C5a acts via receptors C5aR and C5L2. This is a preliminary study aimed at studying the expression of the C5a receptor on myeloid cells in peripheral blood of patients with ARDS secondary to COVID-19. This study has of primary objective to show there is an overexpression of the C5a receptor in patients with ARDS secondary to COVID-19 compared to control patients (patients with COVID-19 without respiratory distress and healthy volunteers). The medium-term objective is to develop a clinical trial to test the effectiveness of anti-C5aR antibody in this condition.

Official Title
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C5a Receptor Expression in Circulating Myeloid Cells in ARDS Secondary to COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Other: draw blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For patients in resuscitation unit with ARDS linked to COVID-19: Patient under invasive mechanical ventilation PaO2 / FiO2 <300 PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample For control patients with COVID-19 without ARDS Oxygen flow always less than 5 L / min PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample No passage in resuscitation unit Favorable evolution Exclusion Criteria: Minors Patient deprived of liberty Patient's refusal to participate at study Patient for whom therapeutic limitation measures such as non-admission to intensive care have been issued Medullar aplasia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19 PATIENTS<br>Two blood samples (40mL) at 2 different points in time: Within the first 72 hours of medical care in resuscitation unit or department. Between the 5th and the 10th day of medical care (ideally at the end of the first week) or on the day of discharge of patient if it is earlier, or of death if it takes place earlier. | Other: draw blood<br>* 40 mL blood sample will be taken within the first three days of hospitalization, a second sample will be taken between the 5th and 10th day of hospitalization and a third sample will be taken on the 10th day of hospitalization or the day of discharge if earlier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Show an overexpression of C5a receptor in patients with ARDS secondary to COVID-19 compared to control patients (patients with COVID-19 without respiratory distress and healthy volunteers). | The endpoint is the expression of the C5a receptor (C5aR) in peripheral blood myeloid cells, expressed as a percentage of cells expressing C5a receptor and as median fluorescence intensity (MFI), during the first 72 hours of patient management in resuscitation unit. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, COVID-19, C5a receptors