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

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT04369820
Collaborator
Innate Pharma (Industry)
100
Enrollment
1
Location
1
Arm
7.1
Anticipated Duration (Months)
14.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: draw blood
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
C5a Receptor Expression in Circulating Myeloid Cells in ARDS Secondary to COVID-19
Actual Study Start Date :
Mar 31, 2020
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: COVID-19 PATIENTS

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
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.

Outcome Measures

Primary Outcome Measures

  1. 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). [72 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique Hôpitaux de Marseille Marseille France 13354

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille
  • Innate Pharma

Investigators

  • Study Director: Emilie EGP GARRIDO-PRADALIE, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT04369820
Other Study ID Numbers:
  • 2020-14
  • IDRCB
First Posted:
Apr 30, 2020
Last Update Posted:
May 4, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique Hopitaux De Marseille
COVID-19
ARDS
C5a receptors
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of May 4, 2020