Clinical trial NCT04355624: Kidney Involvement in COVID-19 Disease (COVKID)
Official title: Characterization of Kidney Involvement in COVID-19 Disease: a French Multi-center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Kidney Injury
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed COVID-19 disease

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


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

Primary outcomes:
measure: Kidney involvement in COVID-19 disease
timeFrame: until 3 months after discharge or death
Secondary outcomes:
measure: Physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection
timeFrame: until 3 months after discharge or death
measure: To identify risk factors for kidney involvement in in SARS-CoV-2 infection
timeFrame: until 3 months after discharge or death
measure: To evaluate the impact of kidney involvement in SARS-CoV-2 infection
timeFrame: until 3 months after discharge or death
measure: 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
timeFrame: until 3 months after discharge
Other outcomes:
Locations:
city: Antibes
country: France
facility: Centre hospitalier d'Antibes Juan les pins
city: Cannes
country: France
facility: Centre hospitalier de Cannes
city: Grasse
country: France
facility: Centre hospitalier de Grasse
city: Nice
country: France
facility: CHU de Nice
Study officials:
References: