Kidney Involvement in COVID-19 Disease (COVKID)

Completed

• Conditions: COVID; Kidney Injury

• Registration Number: NCT04355624
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Primary Completion: 2020-04-19
• Study Completion: 2020-04-19
• Study First Posted: 2020-04-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kidney involvement in COVID-19 disease	until 3 months after discharge or death	Rate of kidney involvement in COVID-19 disease characterized by clinical and biological data

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Centre hospitalier de Cannes; 🇫🇷 Cannes, France

Centre hospitalier de Grasse; 🇫🇷 Grasse, France

CHU de Nice; 🇫🇷 Nice, France

Centre hospitalier d'Antibes Juan les pins; 🇫🇷 Antibes, France