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Apelin; ACE2 and Biomarkers of Alveolar-capillary Permeability in SARS-cov-2 (COVID-19). (APEL-COVID)

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ClinicalTrials.gov Identifier: NCT04632732
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
University Hospital, Angers
Information provided by (Responsible Party):
Olivier Lesur, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Brief Summary:

Hypothesis: The apelin/APJ system is involved in the protection of the lung affected by the COVID-19 by interacting with the SARS-coV-2 entry door: the Angiotensin I Converting Enzyme 2 (ACE2) and the renin-angiotensin system (ras). Elevated systemic levels of apelins and ACE2 activity are associated to less critical forms of COVID-19 and characterized by less pulmonary hyperpermeability and inflammation.

Goals: Main: In COVID-19+ patients, to establish the basic knowledge of 1) apelins and related systems (ras and degradation enzymes, of which ACE2) pheno-dynamic profile in bloodstream, 2) pulmonary hyperpermeability profile by biomarker's assessment i) comparison of SARS vs. lesser COVID-19 respiratory injury, and with non COVID-19 ARDS and non ARDS acute respiratory condition. Secondary: To set up links between basic and progressive clinical data (data collection system APEL-COVID).


Condition or disease Intervention/treatment
Covid19 Diagnostic Test: COVID-19 test Diagnostic Test: Blood sampling

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Apelin; ACE2 and Biomarkers of Alveolar-capillary Permeability in SARS-cov-2 (COVID-19).
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : October 7, 2021
Estimated Study Completion Date : December 1, 2021

Group/Cohort Intervention/treatment
COVID+, SARS
patients COVID+ SARS mechanically ventilated and/or needing more than 6L/min of O2-40% FiO2 for a SpO2 equal or above 90% for more than 24hours.
Diagnostic Test: COVID-19 test
Nasal pharyngeal swab

Diagnostic Test: Blood sampling
20cc of blood will be collected each 7 days during 28 days.

COVID+, nonSARS
patients COVID+ nonSARS respiratory symptomatic, with or without lung infiltrates, non mechanically ventilated, and needing less than 6L/min O2-40% FiO2 for a SpO2 equal or above 90%. They are hospitalized on floors (pulmonolgy, internal medecine or in intensives cares units).
Diagnostic Test: COVID-19 test
Nasal pharyngeal swab

Diagnostic Test: Blood sampling
20cc of blood will be collected each 7 days during 28 days.

COVID-, ARDS
patients are in ARDS according to the Berlin definition and the lung injury is categorized in the direct form (e.g. pneumonia, aspiration).
Diagnostic Test: COVID-19 test
Nasal pharyngeal swab

Diagnostic Test: Blood sampling
20cc of blood will be collected each 7 days during 28 days.

COVID-, nonARDS
patients are not in ARDS according to the Berlin definition but are respiratory symptomatic, with or without lung infiltrates and needing less than 6L O2/min-40% FiO2 for a SpO2 equal or above 90%.
Diagnostic Test: COVID-19 test
Nasal pharyngeal swab

Diagnostic Test: Blood sampling
20cc of blood will be collected each 7 days during 28 days.

COVID-, control, MV+
patients hospitalized and mechanically ventilated for non-respiratory reasons (post hoc with sex-age matching).
Diagnostic Test: COVID-19 test
Nasal pharyngeal swab

Diagnostic Test: Blood sampling
20cc of blood will be collected each 7 days during 28 days.

COVID-, control, MV-
non mechanically ventilated patients hospitalized for non-respiratory reasons (post hoc with sex-age matching).
Diagnostic Test: COVID-19 test
Nasal pharyngeal swab

Diagnostic Test: Blood sampling
20cc of blood will be collected each 7 days during 28 days.




Primary Outcome Measures :
  1. Blood apelins-13/12, -17/16, -36 [ Time Frame: 28 days ]
    Measurement by MS/MS of the blood apelins-13/12, -17/16, -36 each 7 days during 28 days.

  2. Blood angiotensin II [ Time Frame: 28 days ]
    Measurement by ELISA of the blood angiotensin II each 7 days during 28 days.

  3. Blood Clara cell protein (CC16) [ Time Frame: 28 days ]
    Measurement by ELISA of the blood CC16 each 7 days during 28 days.

  4. Blood interleukine-6 (IL-6) [ Time Frame: 28 days ]
    Measurement by ELISA of the blood IL-6 each 7 days during 28 days.

  5. Blood surfactant protein D (SP-D) [ Time Frame: 28 days ]
    Measurement by ELISA of the blood SP-D each 7 days during 28 days.

  6. Plasma apelins degradation speed measurement by UPLC [ Time Frame: 28 days ]
    Measurement of the apelins degradation speed in plasma each 7 days during 28 days.

  7. Plasma ACE2 activity measurement by fluorometry [ Time Frame: 28 days ]
    Measurement of the plasma ACE2 activity each 7 days during 28 days.

  8. Plasma kallikrein activity measurement by fluorometry [ Time Frame: 28 days ]
    Measurement of the plasma kallikrein activity each 7 days during 28 days.

  9. Plasma neprilysin activity measurement by fluorometry [ Time Frame: 28 days ]
    Measurement of the plasma neprilysin activity each 7 days during 28 days.

  10. Plasma ras activity measurement by fluorometry [ Time Frame: 28 days ]
    Measurement of the plasma ras activity each 7 days during 28 days.


Secondary Outcome Measures :
  1. APACHEII [ Time Frame: 28 days ]
    Prognostic score (APACHEII) each day during 28 days.

  2. Oxygenation index [ Time Frame: 28 days ]
    Oxygenation index each day during 28 days.

  3. Mechanical ventilation [ Time Frame: 28 days ]
    Duration of the mechanical ventilation.

  4. Pulmonary compliance (Dynamic, real-time, on ventilator device: Tidal volume / Plateau pressure - PEEP [ Time Frame: 28 days ]
    Measurement of the pulmonary compliance each day during 28 days.

  5. Length of hospital stay [ Time Frame: 28 days ]
    Measurement of the length of hospital stay and/or mortality in-hospital.

  6. SOFA [ Time Frame: 28 days ]
    Prognostic score (SOFA) each day during 28 days.


Biospecimen Retention:   Samples Without DNA
10cc of blood in EDTA tube and 10cc of blood in heparin tube (up to 5 times). Recovered blood plasma.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients hospitalized on floors (pulmonology or in internal medecine) or in intensive care units of the Sherbrooke hospital/CHUS and patients hospitalized in intensive care units of the Angers hospital/CHUA.
Criteria

Inclusion Criteria:

  • For the 4 -non-control- major groups:
  • Adults patients hospitalized for symptomatic acute (presumably infectious) respiratory illness
  • In the 36 hours after admission.

Exclusion Criteria:

  • Patients already hospitalized for more than 36 hours.
  • Pediatric patients.
  • Asymptomatic patients.
  • Non acute respiratory illness patients.
  • Primary pulmonary embolism as causative (i.e pulmonary embolism can be concomitant to respiratory symptoms related to SRAS COVID but not without).
  • Exacerbated terminal/severe COPD of Pulmonary fibrosis with or without home oxygen.
  • Patients with indirect form of ARDS.
  • Cystic fibrosis.

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): NCT04632732


Contacts
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Contact: Olivier Lesur, MD PhD 819-346-1110 ext 14881 olivier.lesur@usherbrooke.ca
Contact: Frédéric Chagnon, MSc 819-346-1110 ext 15731 frederic.chagnon@usherbrooke.ca

Locations
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Canada, Quebec
Sherbrooke University Recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Contact: Olivier Lesur, MD PhD    819-346-1110 ext 14881    olivier.lesur@usherbrooke.ca   
Contact: Frédéric Chagnon, MSc    819-346-1110 ext 15731    frederic.chagnon@usherbrooke.ca   
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
University Hospital, Angers
Investigators
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Principal Investigator: Olivier Lesur, MD PhD Sherbrooke University
Publications:
Toniati P, Piva S, Cattalini M, Garrafa E, Regola F, Castelli F, Franceschini F, Airò P, Bazzani C, Beindorf EA, Berlendis M, Bezzi M, Bossini N, Castellano M, Cattaneo S, Cavazzana I, Contessi GB, Crippa M, Delbarba A, De Peri E, Faletti A, Filippini M, Filippini M, Frassi M, Gaggiotti M, Gorla R, Lanspa M, Lorenzotti S, Marino R, Maroldi R, Metra M, Matteelli A, Modina D, Moioli G, Montani G, Muiesan ML, Odolini S, Peli E, Pesenti S, Pezzoli MC, Pirola I, Pozzi A, Proto A, Rasulo FA, Renisi G, Ricci C, Rizzoni D, Romanelli G, Rossi M, Salvetti M, Scolari F, Signorini L, Taglietti M, Tomasoni G, Tomasoni LR, Turla F, Valsecchi A, Zani D, Zuccalà F, Zunica F, Focà E, Andreoli L, Latronico N. Tocilizumab for the treatment of severe COVID-19 pneumonia with hyperinflammatory syndrome and acute respiratory failure: A single center study of 100 patients in Brescia, Italy. Autoimmun Rev. 2020 Jul;19(7):102568. doi: 10.1016/j.autrev.2020.102568. Epub 2020 May 3. Review.

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Responsible Party: Olivier Lesur, Dr, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT04632732    
Other Study ID Numbers: 2021-3862-APEL-COVID
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Olivier Lesur, Centre de recherche du Centre hospitalier universitaire de Sherbrooke:
Covid19
Apelins
ACE2
ras
ARDS
SARS
lung permeability biomarkers
ELABELA
inflammation
kallikrein-kinin