COVID 19Nancy-CovH-AKINCT04354610
Cardiovascular and Renal Biomarkers to Predict Acute Heart or Kidney Injury in Severe Covid-19 Infection
A study testing Biological samples specific to research, Clinical examination and Telephone follow-up in people with COVID 19, run by Central Hospital, Nancy, France at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19
- What is being tested?
- Biological samples specific to research, Clinical examination and Telephone follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Apr 2020to 26 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Nancy
Nancy, 54000
CHRU de Nancy
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection
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
Read the detailed 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:
- AKI KDIGO grade 1 or higher or elevation of troponin >99th percentile in hospitalisation (approach with AND without a priori)
- AKI KDIGO grade 1 or higher
- Elevation of troponin >99th percentile in hospitalisation
- Elevated serum creatinine >30% in hospital
- Chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital
- Cardiovascular events (stroke, myocardial infarction, hospitalization for heart failure, cardiovascular death) and mortality in hospital and at three months after discharge from hospital
- 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 /)
- Conditions
- COVID 19
- Being tested
- Biological samples specific to research, Clinical examination, Telephone follow-up
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples specific to researchProcedure or surgery
Blood samples, saliva collection, and urine collection to carry out biomarker assays and for the constitution of a biological collection.
Clinical examinationProcedure or surgery
Clinical examination
Telephone follow-upProcedure or surgery
Telephone follow-up at 3 months after discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized for Covid-19 infection | Other | Patients hospitalized for Covid-19 infection will undergo the following evaluations:
* Clinical examination
* Blood sample retrieved for biological assessment and biobanking
* Telephone interview Receives: Procedure: Biological samples specific to research; Procedure: Clinical examination; Procedure: Telephone follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From inclusion to hospital discharge, an average of 21 days
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)
Measured: From inclusion to hospital discharge, an average of 21 days
Secondary outcomes (8)
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 )
Measured: From inclusion to hospital discharge, an average of 21 days
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)
Measured: From inclusion to hospital discharge, an average of 21 days
AKI KDIGO grade 1 or higher
AKI KDIGO grade 1 in hospitalisation
Measured: From inclusion to hospital discharge, an average of 21 days
Association with troponin elevation >99th
Association with troponin elevation >99th percentile during hospitalisation
Measured: From inclusion to hospital discharge, an average of 21 days
Association with elevation of serum creatinine >30%
Association with elevation of serum creatinine >30% during hospitalisation
Measured: From inclusion to hospital discharge, an average of 21 days
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
Measured: 3 months after discharge from hospital
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
Measured: From inclusion to three months after discharge from hospital
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
Measured: From inclusion to three months after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start27 Apr 2020
- Primary completion19 Dec 2020
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Patrick ROSSIGNOL, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354610
- Sponsor's protocol ID
- 2020PI072
- Acronym
- Nancy-CovH-AKI
- Status last verified
- Jan 2021
- First submitted
- 14 Apr 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04354610
- Acronym / sponsor ID
- Nancy-CovH-AKI / 2020PI072
- Conditions
- COVID 19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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:
- AKI KDIGO grade 1 or higher or elevation of troponin >99th percentile in hospitalisation (approach with AND without a priori)
- AKI KDIGO grade 1 or higher
- Elevation of troponin >99th percentile in hospitalisation
- Elevated serum creatinine >30% in hospital
- Chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital
- Cardiovascular events (stroke, myocardial infarction, hospitalization for heart failure, cardiovascular death) and mortality in hospital and at three months after discharge from hospital
- 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 /)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized for Covid-19 infection | Other | Procedure: Biological samples specific to research, Procedure: Clinical examination, Procedure: Telephone follow-upPatients hospitalized for Covid-19 infection will undergo the following evaluations: * Clinical examination * Blood sample retrieved for biological assessment and biobanking * Telephone interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samples specific to researchBlood samples, saliva collection, and urine collection to carry out biomarker assays and for the constitution of a biological collection. | Procedure or surgery | Patients hospitalized for Covid-19 infection |
| Clinical examinationClinical examination | Procedure or surgery | Patients hospitalized for Covid-19 infection |
| Telephone follow-upTelephone follow-up at 3 months after discharge from hospital | Procedure or surgery | Patients hospitalized for Covid-19 infection |
Primary outcome
Worsening of renal function by at least KDIGO grade 1 during hospitalization for Covid-19 infection
Time frame: From inclusion to hospital discharge, an average of 21 days
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).
Troponin greater than 99th percentile during hospitalization for Covid-19 infection
Time frame: From inclusion to hospital discharge, an average of 21 days
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)
8 secondary outcomes
AKI KDIGO grade 1 or higher in hospitalisation (approach with AND without a priori)
Time frame: From inclusion to hospital discharge, an average of 21 days
Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori)
Time frame: From inclusion to hospital discharge, an average of 21 days
AKI KDIGO grade 1 or higher
Time frame: From inclusion to hospital discharge, an average of 21 days
Association with troponin elevation >99th
Time frame: From inclusion to hospital discharge, an average of 21 days
Association with elevation of serum creatinine >30%
Time frame: From inclusion to hospital discharge, an average of 21 days
With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2)
Time frame: 3 months after discharge from hospital
The occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) during hospitalisation and three months after discharge from hospital
Time frame: From inclusion to three months after discharge from hospital
The occurrence of death from any cause during hospitalisation and three months after discharge from hospital
Time frame: From inclusion to three months after discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples specific to research, Clinical examination and Telephone follow-up in people with COVID 19, run by Central Hospital, Nancy, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worsening of renal function by at least KDIGO grade 1 during hospitalization for Covid-19 infection (time frame: From inclusion to hospital discharge, an average of 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.