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NCT Number: NCT04355624

Kidney Involvement in COVID-19 Disease (COVKID)

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier d'Antibes Juan les pins, Antibes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Kidney involvement in COVID-19 disease

    Time frame: until 3 months after discharge or death

    Rate of kidney involvement in COVID-19 disease characterized by clinical and biological data

Secondary outcomes

  1. Physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection

    Time frame: until 3 months after discharge or death

    biological data and histopathological data if available

  2. To identify risk factors for kidney involvement in in SARS-CoV-2 infection

    Time frame: until 3 months after discharge or death

    Rate of death

  3. To evaluate the impact of kidney involvement in SARS-CoV-2 infection

    Time frame: until 3 months after discharge or death

    Legnth of hopital stay

  4. 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

    Time frame: until 3 months after discharge

    Recovery of Kidney fonction

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: COVKID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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