NCT04632732

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

November 3, 2020

Last Update Submit

December 21, 2022

Conditions

Covid19

Keywords

Covid19ApelinsACE2rasARDSSARSlung permeability biomarkersELABELAinflammationkallikrein-kinin

Outcome Measures

Primary Outcomes (8)

  • Blood apelins-13/12, -17/16, -36

    Measurement by MS/MS of the blood apelins-13/12, -17/16, -36 each 7 days during 28 days.

    28 days

  • Blood angiotensin II

    Measurement by ELISA of the blood angiotensin II each 7 days during 28 days.

    28 days

  • Blood Clara cell protein (CC16)

    Measurement by ELISA of the blood CC16 each 7 days during 28 days.

    28 days

  • Blood interleukine-6 (IL-6)

    Measurement by ELISA of the blood IL-6 each 7 days during 28 days.

    28 days

  • Blood surfactant protein D (SP-D)

    Measurement by ELISA of the blood SP-D each 7 days during 28 days.

    28 days

  • Plasma ACE2 activity measurement by fluorometry

    Measurement of the plasma ACE2 activity each 7 days during 28 days.

    28 days

  • Plasma lysyl oxidase activity measurement by fluorometry

    Measurement of the plasma lysyl oxidase activity each 7 days during 28 days.

    28 days

  • Plasma neprilysin activity measurement by fluorometry

    Measurement of the plasma neprilysin activity each 7 days during 28 days.

    28 days

Secondary Outcomes (6)

  • APACHEII

    28 days

  • Oxygenation index

    28 days

  • Mechanical ventilation

    28 days

  • Pulmonary compliance (Dynamic, real-time, on ventilator device: Tidal volume / Plateau pressure - PEEP

    28 days

  • Length of hospital stay

    28 days

  • +1 more secondary outcomes

Study Arms (6)

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 testDiagnostic Test: Blood sampling

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 testDiagnostic Test: Blood sampling

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 testDiagnostic Test: Blood sampling

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 testDiagnostic Test: Blood sampling

COVID-, control, MV+

patients hospitalized and mechanically ventilated for non-respiratory reasons (post hoc with sex-age matching).

Diagnostic Test: COVID-19 testDiagnostic Test: Blood sampling

COVID-, control, MV-

non mechanically ventilated patients hospitalized for non-respiratory reasons (post hoc with sex-age matching).

Diagnostic Test: COVID-19 testDiagnostic Test: Blood sampling

Interventions

COVID-19 testDIAGNOSTIC_TEST

Nasal pharyngeal swab

COVID+, SARSCOVID+, nonSARSCOVID-, ARDSCOVID-, control, MV+COVID-, control, MV-COVID-, nonARDS
Blood samplingDIAGNOSTIC_TEST

20cc of blood will be collected each 7 days during 28 days.

COVID+, SARSCOVID+, nonSARSCOVID-, ARDSCOVID-, control, MV+COVID-, control, MV-COVID-, nonARDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherbrooke University

Sherbrooke, Quebec, J1H5N4, Canada

Location

Related Publications (49)

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  • Lesur O, Segal ED, Rego K, Mercat A, Asfar P, Chagnon F. Process-Specific Blood Biomarkers and Outcomes in COVID-19 Versus Non-COVID-19 ARDS (APEL-COVID Study): A Prospective, Observational Cohort Study. J Clin Med. 2024 Oct 4;13(19):5919. doi: 10.3390/jcm13195919.

    PMID: 39407979DERIVED

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.

MeSH Terms

Conditions

COVID-19Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Olivier Lesur, MD PhD

    Sherbrooke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 17, 2020

Study Start

October 26, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)