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

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ClinicalTrials.gov Identifier: NCT04369820
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
Innate Pharma
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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
COVID-19 Other: draw blood Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 31, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: COVID-19 PATIENTS

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.
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.




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). [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369820


Contacts
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Contact: Julien JC CARVELLI, MD 04 13 42 95 35 ext +33 Julien.CARVELLI@ap-hm.fr
Contact: Kahéna KA AMICHI 04 91 38 19 66 ext +33 Kahena.AMICHI@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Julien CARVELLI    04 13 42 95 35 ext +33    Julien.CARVELLI@ap-hm.fr   
Contact: Kahéna AMICHI    04 91 38 19 66 ext +33    kahena.amichi@ap-hm.fr   
Sub-Investigator: Marc GAINNIER         
Sub-Investigator: Nicolas SCHLEINITZ         
Sub-Investigator: Lionel VELLY         
Sub-Investigator: Laurent PAPAZIAN         
Sub-Investigator: Pierre-Yves CORDIER         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Innate Pharma
Investigators
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Study Director: Emilie EGP GARRIDO-PRADALIE Assistance Publique Hôpitaux de Marseille
Publications:

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT04369820    
Other Study ID Numbers: 2020-14
IDRCB ( Other Identifier: 2020-A00757-32 )
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020

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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