Kidney Involvement in COVID-19 Disease (COVKID)

COVID Clinical Trial

— COVKID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04355624
• Other study ID #: 20reamedcovid02
• Status: Recruiting
• Start date: April 15, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: April 2020
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Sonia Boyer-Suavet
• Phone: + 33 92 03 55 10
• Email: boyer-suavet.s[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Kidney Injury

Locations

Country	Name	City	State
France	Centre hospitalier d'Antibes Juan les pins	Antibes
France	Centre hospitalier de Cannes	Cannes
France	Centre hospitalier de Grasse	Grasse
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection	biological data and histopathological data if available	until 3 months after discharge or death
Secondary	To identify risk factors for kidney involvement in in SARS-CoV-2 infection	Rate of death	until 3 months after discharge or death
Secondary	To evaluate the impact of kidney involvement in SARS-CoV-2 infection	Legnth of hopital stay	until 3 months after discharge or death
Secondary	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