C5a Receptor Expression - COVID-19 (C5-COV) (C5-COV)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
draw blood
Sponsored by

About this trial
This is an interventional other trial for COVID-19 focused on measuring COVID-19, ARDS, C5a receptors
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COVID-19 PATIENTS
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04369820
First Posted
April 29, 2020
Last Updated
August 9, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
Collaborators
Innate Pharma
1. Study Identification
Unique Protocol Identification Number
NCT04369820
Brief Title
C5a Receptor Expression - COVID-19 (C5-COV)
Acronym
C5-COV
Official Title
C5a Receptor Expression in Circulating Myeloid Cells in ARDS Secondary to COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
August 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
Collaborators
Innate Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, ARDS, C5a receptors
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID-19 PATIENTS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
draw blood
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie EGP GARRIDO-PRADALIE
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
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C5a Receptor Expression - COVID-19 (C5-COV)
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