Covid19NCT04491227
Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection
An observational study of Covid19 and AKI, run by University of California, San Diego at 12 sites in 6 countries.
Trial summary
The coronavirus (COVID-19) pandemic has created a significant strain on health care resources across the world for managing critically ill patients. Emerging reports from China, South Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with a mortality of 60-80% however there is no… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 2,000 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 5 May 2020to 31 Mar 2023
- 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 infection with acute and chronic kidney dysfunction. Patients testing positive for COVID19 who meet criteria for AKI, have known CKD (with baseline eGFR less than 60), are ESKD on dialysis or kidney transplant recipients will be enrolled in the study.
Who may be able to join
- Patients with confirmed infection with COVID 19
- Patients with Acute Kidney injury (AKI) or Chronic kidney disease (CKD) or need for dialysis
- Patients receiving Chronic dialysis (hemo or peritoneal dialysis)
- Renal transplant recipients
Who cannot join
- • Patients < 18 yrs age
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
United States5 sites
St. Peter's Hospital
Albany, New York, 12208
University of Colorado
Aurora, Colorado, 80045
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Jacobi Medical Center
New York, New York, 10461
University of California, San Diego
San Diego, California, 92103
United Kingdom3 sites
Royal Free Hospital
London, NW3 2QG
Guy's & St Thomas's Hospital
London, SE1 7EH
University of Nottingham
Nottingham, NG7 2RD
About this study
The coronavirus (COVID-19) pandemic has created a significant strain on health care resources across the world for managing critically ill patients. Emerging reports from China, South Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with a mortality of 60-80% however there is no systematic assessment of the risk factors, recognition, course and outcomes in patients with and without kidney disease whose course is complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal transplants and ESKD patients are at high risk for COVID-19 infection and there is limited information on the effect of COVID-19 on the course and outcomes of these patients. The requirement for renal support including IHD, CRRT and sorbent based therapies has been variable and has contributed to the intense pressure on the nephrology and critical care providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and abroad, there is an intense need to understand the epidemiology of the disease and the resources needed for renal support to inform clinical management and public health interventions.
In this study, the investigators aim to investigate health care facilities across the world (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global picture of incidence, risk factors, resources available for treatment and prognosis of acute and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to identify trends in patients with acute and chronic kidney disease, determine its incidence, treatment and outcomes in different settings across the world. This information will be used to develop and implement educational tools and resources to prevent deaths from AKI and progression of CKD in this and following pandemics.
Read the detailed description
Acute and Chronic kidney diseases are important causes of mortality and morbidity worldwide. The associated socioeconomic burden of kidney disease and AKI, as in some cases recovery is incomplete and chronic kidney disease (CKD) can arise, is a growing problem around the world. During the COVID 19 pandemic the incidence of AKI has been reported to be as low as 0.5% to as high as 23%. AKI was reported to develop at a median of 15 days in one study, and another study reported that most AKI developed within 7 days of admission. The data on acute kidney injury (AKI) in patients with COVID-19 is mostly from patients who are hospitalized, and in some studies limited to critically ill patients in the ICU. In ICU patients the requirement for renal support and mortality is reported to be high, however is a lack of epidemiological studies specifically designed to determine the impact of COVID 19 on kidney outcomes.
The mortality rate of patients with kidney dysfunction varies widely and is inversely related to country income and percentage of gross domestic product spent on total health expenditure. Several initiatives will be very insightful and identified important gaps in knowledge, more effort is required to understand this problem affecting all regions of the globe. In order to eventually implement resources and tools to help prevent, diagnose and treat patients with COVID 19 infection and kidney dysfunction, the investigators need to understand its incidence, risk factors, available resources and barriers to diagnosis and treatment.
This project will collect data on kidney function progression in patients infected with COVID 19 across the world. The study will open to individual physicians across the world who agreed to participate by providing de-identified clinical and lab data of patients with confirmed COVID 19 infection with acute and chronic kidney dysfunction.
Primary Objectives:
- Establish incidence and outcomes of acute kidney injury (AKI) in different settings worldwide during the COVID 19 pandemic.
Secondary Objectives:
- Compare risk factors, etiologies, diagnosis, management and outcomes of acute and chronic kidney dysfunction in COVID 19 patients in different countries
- Determine resources available for recognition, non-dialytic and dialytic management and follow up of patients with acute and chronic kidney dysfunction and COVID 19 infection in different settings and countries.
- Determine long term outcomes, 6 months and 1 year, of patients with acute and chronic kidney dysfunction and COVID 19 infection in different settings.
- Evaluate barriers preventing access to the standard treatments of acute and chronic kidney dysfunction and COVID 19 infection across different countries.
- Determine the impact of COVID 19 infection on the progression of acute and chronic kidney disease in patient with native and transplanted kidney.
- Evaluate the treatment strategies of patient with ESKD on hospitalized patients with COVID 19.
- Conditions
- Covid19, AKI, CKD, ESRD, Transplant;Failure,Kidney
- Keywords
- AKI, dialysis, CKD, COVID19, renal transplant, mortality, renal recovery, resource utilization
- Medical subject headings
- COVID-19, Kidney Failure, Chronic
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 |
|---|---|---|
| Kidney disease in COVID-19 | Chronic Kidney Disease (CKD): Known diagnosis of chronic kidney disease; prior evidence of markers of kidney damage for 3 months (microalbuminuria, proteinuria >300mg/24 hrs or abnormalities in imaging tests) or the presence of glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 3 months calculated with CKD-EPI equation, with or without other signs of kidney damage as described above. ESKD: Patients that are dialysis dependent. Suspected AKI: Oliguria (<200 mL/6 hours) and any AKI-related clinical signs or symptoms (see table 1) or urinalysis/dipstick abnormality. All suspected AKI cases must be confirmed prior to enrollment. Confirmed AKI: Meeting of at least one of the modified KDIGO Criteria * Increase or decrease in serum creatinine >0.3 mg/dl from reference in 48 hours * Increase or decrease in serum creatinine > 50% from reference in 7 days * Urine output < 400 ml/day Functioning Kidney transplant: |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI incidence
Meeting of at least one of the modified KDIGO Criteria
- Increase or decrease in serum creatinine >0.3 mg/dl from reference in 48 hours
- Increase or decrease in serum creatinine > 50% from reference in 7 days
- Urine output < 400 ml/day
Measured: from hospital admission through hospital discharge upto 24 weeks
Dialysis requirement
initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay
Measured: through study completion upto 1 year from enrollment
hospital mortality
Deaths during primary hospitalization
Measured: through study completion within 1 year
Secondary outcomes (3)
Renal functional recovery
C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent Percentage of patinets with renal functioanl recovery based on serum creatinien levels classfied as C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent
Measured: Assessed at at 3, 6 and 12 months from enrollment at hospital admission
Functional status
EQL5D scale and SH8 scales completed at 3, 6 and 12 months post enrollment
Measured: questionnaires to be completed at 3, 6 and 12 months from enrollment at hospital admission
Resource utilization
Number of days patient is in the hospital and ICU and is managed with ventilators, dialysis or other extracorporeal organ support e.g. ECMO during the hospital stay
Measured: Within 1 year of enrollment for primary hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start5 May 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ravindra Mehta, University of California, San Diego
- Investigators
- Ravindra L Mehta, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491227
- Sponsor's protocol ID
- 000295
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participating sites will have acess to their own data and aggregate data
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04491227
- Acronym / sponsor ID
- 000295
- Conditions
- Covid19, AKI, CKD, ESRD, Transplant;Failure,Kidney
- Keywords
- AKI, dialysis, CKD, COVID19, renal transplant, mortality, renal recovery, resource utilization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 29 Jul 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.
The coronavirus (COVID-19) pandemic has created a significant strain on health care resources across the world for managing critically ill patients. Emerging reports from China, South Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with a mortality of 60-80% however there is no systematic assessment of the risk factors, recognition, course and outcomes in patients with and without kidney disease whose course is complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal transplants and ESKD patients are at high risk for COVID-19 infection and there is limited information on the effect of COVID-19 on the course and outcomes of these patients. The requirement for renal support including IHD, CRRT and sorbent based therapies has been variable and has contributed to the intense pressure on the nephrology and critical care providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and abroad, there is an intense need to understand the epidemiology of the disease and the resources needed for renal support to inform clinical management and public health interventions.
In this study, the investigators aim to investigate health care facilities across the world (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global picture of incidence, risk factors, resources available for treatment and prognosis of acute and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to identify trends in patients with acute and chronic kidney disease, determine its incidence, treatment and outcomes in different settings across the world. This information will be used to develop and implement educational tools and resources to prevent deaths from AKI and progression of CKD in this and following pandemics.
Detailed description
Acute and Chronic kidney diseases are important causes of mortality and morbidity worldwide. The associated socioeconomic burden of kidney disease and AKI, as in some cases recovery is incomplete and chronic kidney disease (CKD) can arise, is a growing problem around the world. During the COVID 19 pandemic the incidence of AKI has been reported to be as low as 0.5% to as high as 23%. AKI was reported to develop at a median of 15 days in one study, and another study reported that most AKI developed within 7 days of admission. The data on acute kidney injury (AKI) in patients with COVID-19 is mostly from patients who are hospitalized, and in some studies limited to critically ill patients in the ICU. In ICU patients the requirement for renal support and mortality is reported to be high, however is a lack of epidemiological studies specifically designed to determine the impact of COVID 19 on kidney outcomes.
The mortality rate of patients with kidney dysfunction varies widely and is inversely related to country income and percentage of gross domestic product spent on total health expenditure. Several initiatives will be very insightful and identified important gaps in knowledge, more effort is required to understand this problem affecting all regions of the globe. In order to eventually implement resources and tools to help prevent, diagnose and treat patients with COVID 19 infection and kidney dysfunction, the investigators need to understand its incidence, risk factors, available resources and barriers to diagnosis and treatment.
This project will collect data on kidney function progression in patients infected with COVID 19 across the world. The study will open to individual physicians across the world who agreed to participate by providing de-identified clinical and lab data of patients with confirmed COVID 19 infection with acute and chronic kidney dysfunction.
Primary Objectives:
- Establish incidence and outcomes of acute kidney injury (AKI) in different settings worldwide during the COVID 19 pandemic.
Secondary Objectives:
- Compare risk factors, etiologies, diagnosis, management and outcomes of acute and chronic kidney dysfunction in COVID 19 patients in different countries
- Determine resources available for recognition, non-dialytic and dialytic management and follow up of patients with acute and chronic kidney dysfunction and COVID 19 infection in different settings and countries.
- Determine long term outcomes, 6 months and 1 year, of patients with acute and chronic kidney dysfunction and COVID 19 infection in different settings.
- Evaluate barriers preventing access to the standard treatments of acute and chronic kidney dysfunction and COVID 19 infection across different countries.
- Determine the impact of COVID 19 infection on the progression of acute and chronic kidney disease in patient with native and transplanted kidney.
- Evaluate the treatment strategies of patient with ESKD on hospitalized patients with COVID 19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney disease in COVID-19 | – | –Chronic Kidney Disease (CKD): Known diagnosis of chronic kidney disease; prior evidence of markers of kidney damage for 3 months (microalbuminuria, proteinuria >300mg/24 hrs or abnormalities in imaging tests) or the presence of glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 3 months calculated with CKD-EPI equation, with or without other signs of kidney damage as described above. ESKD: Patients that are dialysis dependent. Suspected AKI: Oliguria (<200 mL/6 hours) and any AKI-related clinical signs or symptoms (see table 1) or urinalysis/dipstick abnormality. All suspected AKI cases must be confirmed prior to enrollment. Confirmed AKI: Meeting of at least one of the modified KDIGO Criteria * Increase or decrease in serum creatinine >0.3 mg/dl from reference in 48 hours * Increase or decrease in serum creatinine > 50% from reference in 7 days * Urine output < 400 ml/day Functioning Kidney transplant: |
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 infection with acute and chronic kidney dysfunction. Patients testing positive for COVID19 who meet criteria for AKI, have known CKD (with baseline eGFR less than 60), are ESKD on dialysis or kidney transplant recipients will be enrolled in the study.
Key inclusion criteria (4 listed)
- Patients with confirmed infection with COVID 19
- Patients with Acute Kidney injury (AKI) or Chronic kidney disease (CKD) or need for dialysis
- Patients receiving Chronic dialysis (hemo or peritoneal dialysis)
- Renal transplant recipients
Key exclusion criteria (1 listed)
- • Patients < 18 yrs age
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
AKI incidence
Time frame: from hospital admission through hospital discharge upto 24 weeks
Meeting of at least one of the modified KDIGO Criteria * Increase or decrease in serum creatinine >0.3 mg/dl from reference in 48 hours * Increase or decrease in serum creatinine > 50% from reference in 7 days * Urine output < 400 ml/day
Dialysis requirement
Time frame: through study completion upto 1 year from enrollment
initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay
hospital mortality
Time frame: through study completion within 1 year
Deaths during primary hospitalization
3 secondary outcomes
Renal functional recovery
Time frame: Assessed at at 3, 6 and 12 months from enrollment at hospital admission
Functional status
Time frame: questionnaires to be completed at 3, 6 and 12 months from enrollment at hospital admission
Resource utilization
Time frame: Within 1 year of enrollment for primary hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No. Participating sites will have acess to their own data and aggregate data
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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.
Ravindra L Mehta principal investigator
University of California, San Diego
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and AKI, run by University of California, San Diego at 12 sites in 6 countries.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom, Bolivia, Canada, Chile and 1 more country. 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?
Results are not available in the source record.
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?
AKI incidence (time frame: from hospital admission through hospital discharge upto 24 weeks). The study lists 3 primary outcomes in all. 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 29 Jul 2020.