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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: COVID-19

Treatments: Other: draw blood

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04369820

2020-14

IDRCB (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

COVID-19 PATIENTS

Experimental group

Description:

Two blood samples (40mL) at 2 different points in time: 1. Within the first 72 hours of medical care in resuscitation unit or department. 2. 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.

Treatment:

Other: draw blood