Kidney Involvement in COVID-19 Disease (COVKID)

NCT04355624 | Completed

• 1 other identifier: 20reamedcovid02
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 4

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

Conditions

COVID; Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 evaluate the impact of kidney involvement 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 Arms (2)

ICU patients

COVID-19 patients admitted in Intensive Care Units

Non ICU patients

COVID-19 patients admitted in conventional units

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed COVID-19 disease

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (4)

Centre hospitalier d'Antibes Juan les pins

Antibes, 06600, France

Location

Centre hospitalier de Cannes

Cannes, 06400, France

Location

Centre hospitalier de Grasse

Grasse, 06130, France

Location

CHU de Nice

Nice, 06300, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and urine. Renal tissue only from post-portem kidney biopsies.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: April 15, 2020
• Primary Completion: April 19, 2020
• Study Completion: April 19, 2020
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)