Skip to main content
Clinical Trials/NCT04355624
NCT04355624
Completed
Not Applicable

Characterization of Kidney Involvement in COVID-19 Disease: a French Multi-center Prospective Observational Study

Centre Hospitalier Universitaire de Nice4 sites in 1 country45 target enrollmentApril 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
45
Locations
4
Primary Endpoint
Kidney involvement in COVID-19 disease
Status
Completed
Last Updated
last year

Overview

Brief Summary

Novel coronavirus disease (COVID-19) is a newly discovered contagious disease caused by SARS-CoV-2 virus, primarily manifesting as an acute respiratory illness with pneumonia, but can affect multiple organs such as kidney, heart, digestive tract, blood and nervous system. In previous reports of SARS and MERS-CoV infections, acute kidney injury was described in 5 to 15% of patients and was associated with a high mortality rate (60-90%). Recent reports showed renal abnormalities in COVID-9 infected patients. A recent Chinese study also reported that acute kidney injury was an independent risk factor for mortality. However, the exact mechanism of kidney involvement remains unclear: sepsis-related cytokine storm or direct cellular injury from the virus. Also, kidney involvement has not yet been well characterized: heavy albuminuria, hematuria or interstitial nephropathy alone.

A recent study identified viral RNA in kidney tissue and another study succeeded isolating SARS-CoV-2 from the urine sample of an infected patient. These data suggest that the kidney might be a target of this novel coronarivus.

The sponsor suggests characterizing kidney involvement in SARS-CoV-2 infection.

Study objectives are:

  • To give an accurate characterization of kidney involvement in COVID-19
  • To investigate the physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection
  • To identify risk factors for kidney involvement in in SARS-CoV-2 infection
  • To evaluate the impact of kidney involvement in in SARS-CoV-2 infection
  • To assess the long-term health effect of kidney injury on survivors of in SARS-CoV-2 infection
Registry
clinicaltrials.gov
Start Date
April 15, 2020
End Date
April 19, 2020
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Confirmed COVID-19 disease
  • Age \> 18 years-old

Exclusion Criteria

  • Age \< 18 years-old
  • Pregnancy
  • Patient with tutor- or curatorship or in prison
  • Patients who had undergone renal replacement therapy (RRT) before admission

Outcomes

Primary Outcomes

Kidney involvement in COVID-19 disease

Time Frame: until 3 months after discharge or death

Rate of kidney involvement in COVID-19 disease characterized by clinical and biological data

Secondary Outcomes

  • To evaluate the impact of kidney involvement in SARS-CoV-2 infection(until 3 months after discharge or death)
  • Physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection(until 3 months after discharge or death)
  • To identify risk factors for kidney involvement in in SARS-CoV-2 infection(until 3 months after discharge or death)
  • To assess the long-term health effect of kidney injury on survivors of SARS-CoV-2 infection in case of AKI KDIGO 2 or 3(until 3 months after discharge)

Study Sites (4)

Loading locations...

Similar Trials