Kidney Involvement in COVID-19 Disease (COVKID) (COVKID)

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

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

Study Overview

• Status: Unknown
• Conditions: COVID; Kidney Injury

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Sonia Boyer-Suavet; Phone Number: + 33 92 03 55 10; Email: boyer-suavet.s@chu-nice.fr
• Study Contact Backup: Name: Hajar Ouahmi; Phone Number: + 33 92 03 55 10; Email: ouahmi.h@chu-nice.fr

Study Locations

• France
  • Antibes, France, 06600
    • Recruiting
    • Centre hospitalier d'Antibes Juan les pins
    • Contact: Philippe DESWARDT; Email: philippe.deswardt@ch-antibes.fr
    • Contact: Sonia BOYER-SUAVET; Email: sonia.boyer@ch-antibes.fr
  • Cannes, France, 06400
    • Recruiting
    • Centre Hospitalier de Cannes
  • Grasse, France, 06130
    • Recruiting
    • Centre hospitalier de Grasse
  • Nice, France, 06300
    • Recruiting
    • CHU de Nice
    • Contact: Sonia Boyer-Suavet,; Email: boyer-suavet.s@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed COVID-19 disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ICU patients; COVID-19 patients admitted in Intensive Care Units
Non ICU patients; COVID-19 patients admitted in conventional units

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 20reamedcovid02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no data sharing plan has been established

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No