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NCT Number: NCT04369820

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

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

draw blood

Other

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Collaborators

  • Innate Pharma

Registry information

Official study title

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

Acronym: C5-COV

Important dates

Study start
2020
Primary completion
2020
Study completion
2023
First posted
Apr 30, 2020
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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