Cardiovascular and Renal Biomarkers to Predict Acute Heart or Kidney Injury in Severe Covid-19 Infection

COVID 19 Clinical Trial

— Nancy-CovH-AKI  

Official title:

Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354610
• Other study ID #: 2020PI072
• Status: Completed
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: January 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Nancy Cov-H-AKI: study is a prospective, non-randomized, monocenter study performed in patients hospitalised for either the severe or the critical form of Covid-19.

The main objective of the Nancy Cov-H-AKI study is to evaluate the association of variations (from inclusion to 72H post-inclusion) of 5 blood-based cardio-vascular-renal biomarkers selected a priori, cardiac (NT-proBNP), coagulation (D-dimers), related to the renin angiotensin aldosterone system (ACE2) and renal (Penkid, and NGAL) with the appearance of acute kidney injury KDIGO grade 1 or higher OR cardiac injury in patients hospitalised for either the severe or the critical form of Covid-19

Description:

Secondary objectives

Evaluate the association of the concentrations at inclusion AND of the variations (between inclusion and 72H post-inclusion) of blood and urine cardiovascular-renal biomarkers of interest (selected a priori: cardiac (NT-proBNP, (bio)-Adrenomedullin), coagulation (D-dimers), linked to the renin angiotensin aldosterone system (renin, ACE2, Angiotensin 2), inflammatory (ceramides), oxidative stress, and renal (PENKID, cystatin C) and renal glomerulo-tubulopathy ( renal functional exploration in blood and urine, and AKI (blood (NGAL, KIM-1) and urinary (IGFBP7-TIMP2)) biomarkers, AND WITHOUT a priori by an analysis of 184 blood protein biomarkers in connection with cardiovascular and inflammatory damage * ) with the appearance of:

1. AKI KDIGO grade 1 or higher or elevation of troponin >99th percentile in hospitalisation (approach with AND without a priori)

2. AKI KDIGO grade 1 or higher

3. Elevation of troponin >99th percentile in hospitalisation

4. Elevated serum creatinine >30% in hospital

5. Chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital

6. Cardiovascular events (stroke, myocardial infarction, hospitalization for heart failure, cardiovascular death) and mortality in hospital and at three months after discharge from hospital

7. Considering future exploratory analyses (biological collection of plasma, serum, saliva, urine, viruses) (for example other OLINK panels) on the previous endpoints

• NGAL (Neutrophil Gelatinase Associated Lipocalin), Cystatin C, Kidney Injury Molecule-1 (Kim-1), ACE-2, renin, Brain-type Natriuretic Peptide (BNP), Adrenomedullin, FGF (fibroblast growth factor-23 are all included in the 2 Olink panels "CVDII" (https://www.olink.com/products/cvd-ii-panel/: listing) and "cardiometabolic" (https://www.olink.com/products/cardiometabolic-panel /)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: March 26, 2021
• Est. primary completion date: December 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over the age of 18,

• Admission for less than 3 days in the medical service (or in intensive care) for proven serious form of Covid 19 infection (respiratory rate >30 / min, or desaturation in air = 93%, or PaO2 / FiO2 = 300mmHg)

• OR Admission for less than 2 days in intensive care (or resuscitation intensive care) for critical form of Covid 19 (shock or respiratory failure).

• GFR greater than 30 ml / min / 1.73m2.

• Troponin <99th percentile.

• Patient affiliated to a social security scheme or beneficiary of such a scheme

• The patient or their representative received complete information on the study and signed and dated the emergency situation informed consent/inclusion form in accordance with article L1122-1-3 of the French Public Health Code (Code de la Santé Publique).

Exclusion Criteria:

Exclusion criterion for patients taking part in clinical research.

• AKI KDIGO grade 1 on the day of visit 1

• Pregnant women, parturient, or nursing mothers

• A person of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice)

• Person deprived of their liberty by a judicial or administrative decision,

• Person undergoing psychiatric treatment under articles L. 3212-1 and L. 3213-1 of the Public Health Code.

Related Conditions & MeSH terms

• COVID 19
• COVID-19

Intervention

Procedure:
• Biological samples specific to research
Blood samples, saliva collection, and urine collection to carry out biomarker assays and for the constitution of a biological collection.
• Clinical examination
Clinical examination
• Telephone follow-up
Telephone follow-up at 3 months after discharge from hospital

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy
France	CHRU de Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worsening of renal function by at least KDIGO grade 1 during hospitalization for Covid-19 infection	Composite endpoint : Worsening of renal function by at least KDIGO grade 1 criteria from inclusion visit OR troponin greater than 99th percentile during hospitalization for Covid-19 infection (with Outcome 2).	From inclusion to hospital discharge, an average of 21 days
Primary	Troponin greater than 99th percentile during hospitalization for Covid-19 infection	Composite endpoint : Worsening of renal function by at least KDIGO grade 1 criteria from inclusion visit OR troponin greater than 99th percentile during hospitalization for Covid-19 infection (with Outcome 1)	From inclusion to hospital discharge, an average of 21 days
Secondary	AKI KDIGO grade 1 or higher in hospitalisation (approach with AND without a priori)	Composite endpoint : AKI KDIGO grade 1 or higher or Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) ((with Outcome 3 )	From inclusion to hospital discharge, an average of 21 days
Secondary	Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori)	Composite endpoint : AKI KDIGO grade 1 or higher or Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) (with Outcome 3)	From inclusion to hospital discharge, an average of 21 days
Secondary	AKI KDIGO grade 1 or higher	AKI KDIGO grade 1 in hospitalisation	From inclusion to hospital discharge, an average of 21 days
Secondary	Association with troponin elevation >99th	Association with troponin elevation >99th percentile during hospitalisation	From inclusion to hospital discharge, an average of 21 days
Secondary	Association with elevation of serum creatinine >30%	Association with elevation of serum creatinine >30% during hospitalisation	From inclusion to hospital discharge, an average of 21 days
Secondary	With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2)	With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital	3 months after discharge from hospital
Secondary	The occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) during hospitalisation and three months after discharge from hospital	Composite outcome : the occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) and death from any cause during hospitalisation and three months after discharge from hospital	From inclusion to three months after discharge from hospital
Secondary	The occurrence of death from any cause during hospitalisation and three months after discharge from hospital	Composite outcome : the occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) and death from any cause during hospitalisation and three months after discharge from hospital	From inclusion to three months after discharge from hospital