Kidney Involvement in COVID-19 Disease (COVKID)

Study Overview
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Brief Summary
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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

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

Conditions
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COVID, Kidney Injury

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU patients<br>COVID-19 patients admitted in Intensive Care Units | |
| Non ICU patients<br>COVID-19 patients admitted in conventional units | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney involvement in COVID-19 disease | Rate of kidney involvement in COVID-19 disease characterized by clinical and biological data | until 3 months after discharge or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection | biological data and histopathological data if available | until 3 months after discharge or death | 
| To identify risk factors for kidney involvement in in SARS-CoV-2 infection | Rate of death | until 3 months after discharge or death | 
| To evaluate the impact of kidney involvement in SARS-CoV-2 infection | Legnth of hopital stay | 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 | Recovery of Kidney fonction | until 3 months after discharge |