COVIDCOVKIDNCT04355624
Kidney Involvement in COVID-19 Disease (COVKID)
An observational study of COVID and Kidney Injury, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Kidney Injury
- How many people
- 45 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Apr 2020to 19 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed COVID-19 disease
Who may be able to join
- Confirmed COVID-19 disease
- Age > 18 years-old
Who cannot join
- Age < 18 years-old
- Pregnancy
- Patient with tutor- or curatorship or in prison
- Patients who had undergone renal replacement therapy (RRT) before admission
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre hospitalier d'Antibes Juan les pins
Antibes, 06600
Centre hospitalier de Cannes
Cannes, 06400
Centre hospitalier de Grasse
Grasse, 06130
CHU de Nice
Nice, 06300
About this study
Official title: 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.
Read more
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | COVID-19 patients admitted in Intensive Care Units | |
| Non ICU patients | COVID-19 patients admitted in conventional units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney involvement in COVID-19 disease
Rate of kidney involvement in COVID-19 disease characterized by clinical and biological data
Measured: until 3 months after discharge or death
Secondary outcomes (4)
Physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection
biological data and histopathological data if available
Measured: until 3 months after discharge or death
To identify risk factors for kidney involvement in in SARS-CoV-2 infection
Rate of death
Measured: until 3 months after discharge or death
To evaluate the impact of kidney involvement in SARS-CoV-2 infection
Legnth of hopital stay
Measured: 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
Measured: until 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start15 Apr 2020
- Primary completion19 Apr 2020
- Study completion19 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355624
- Sponsor's protocol ID
- 20reamedcovid02
- Acronym
- COVKID
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2020
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data sharing plan has been established
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Kidney Involvement in COVID-19 Disease: a French Multi-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04355624
- Acronym / sponsor ID
- COVKID / 20reamedcovid02
- Conditions
- COVID, Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 19 Apr 2020 (actual)
- Study completion
- 19 Apr 2020 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | –COVID-19 patients admitted in Intensive Care Units |
| Non ICU patients | – | –COVID-19 patients admitted in conventional units |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed COVID-19 disease
Key inclusion criteria (2 listed)
- Confirmed COVID-19 disease
- Age > 18 years-old
Key exclusion criteria (4 listed)
- Age < 18 years-old
- Pregnancy
- Patient with tutor- or curatorship or in prison
- Patients who had undergone renal replacement therapy (RRT) before admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection
Time frame: until 3 months after discharge or death
To identify risk factors for kidney involvement in in SARS-CoV-2 infection
Time frame: until 3 months after discharge or death
To evaluate the impact of kidney involvement in SARS-CoV-2 infection
Time frame: 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
Time frame: until 3 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No. no data sharing plan has been established
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Kidney Injury, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney involvement in COVID-19 disease (time frame: until 3 months after discharge or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.