COVID-19NCT05328986
Kidney Disease After COVID-19
An observational study of COVID-19 and Acute Kidney Injury, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
Trial summary
To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Acute Kidney Injury, Chronic Kidney Injury
- How many people
- 1,753 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Jan 2020to 4 Jan 2024
- How long will I take part?
- 4 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with COVID-19.
Who may be able to join
- Adults, age ≥18 years
- Confirmed diagnosis of COVID-19
Who cannot join
- No confirmed diagnosis of COVID-19
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48105
Johns Hopkins University
Baltimore, Maryland, 21287
Yale School of Medicine
New Haven, Connecticut, 06513
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
New Jersey Medical School - Rutgers University
Newark, New Jersey, 07103
About this study
Official title: Multi-center Assessment of Survivors for Kidney Disease After COVID-19
To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.
- Conditions
- COVID-19, Acute Kidney Injury, Chronic Kidney Injury
- Medical subject headings
- COVID-19, Acute 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 |
|---|---|---|
| COVID | Patients who have had a confirmed diagnosis of COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated Glomerular Filtration Rate (eGFR)
Kidneys filter blood by removing waste and extra water to make urine. The kidney's filtration rate, called the glomerular filtration rate (GFR), shows how well the kidneys are filtering. A normal GFR is 60 or higher.
Measured: yearly for 4 years after COVID exposure
Secondary outcomes (2)
Urine Albumin-to-Creatinine Ratio (UACR)
Albuminuria is present when UACR is greater than 30 mg/g and is a marker for chronic kidney disease. Albuminuria is used to diagnose and monitor kidney disease.
Measured: yearly for 4 years after COVID exposure
Urine protein/creatinine ratio (UPCR)
Urine protein/creatinine ratio - Protein creatinine ratio in the urine quantifies the loss of the protein and helps in further evaluation of the kidney function. Normal ratio: < 0.20
Measured: yearly for 4 years after COVID exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start4 Jan 2020
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 1,753 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Medical School, University of Michigan, Yale New Haven Health System Center for Healthcare Solutions, Johns Hopkins University
- Responsible party
- Principal investigator, Evren Azeloglu, Icahn School of Medicine at Mount Sinai
- Investigators
- Evren U. Azeloglu, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328986
- Sponsor's protocol ID
- STUDY-20-01326
- Other IDs
- 1300143
- Status last verified
- Jul 2025
- First submitted
- 13 Apr 2022
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Assessment of Survivors for Kidney Disease After COVID-19
- ClinicalTrials.gov ID
- NCT05328986
- Acronym / sponsor ID
- STUDY-20-01326
- Conditions
- COVID-19, Acute Kidney Injury, Chronic Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,753 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- New Jersey Medical School, University of Michigan, Yale New Haven Health System Center for Healthcare Solutions, Johns Hopkins University
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 14 Apr 2022 (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.
To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID | – | –Patients who have had a confirmed diagnosis of COVID-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID-19.
Key inclusion criteria (2 listed)
- Adults, age ≥18 years
- Confirmed diagnosis of COVID-19
Key exclusion criteria (1 listed)
- No confirmed diagnosis of COVID-19
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
estimated Glomerular Filtration Rate (eGFR)
Time frame: yearly for 4 years after COVID exposure
Kidneys filter blood by removing waste and extra water to make urine. The kidney's filtration rate, called the glomerular filtration rate (GFR), shows how well the kidneys are filtering. A normal GFR is 60 or higher.
2 secondary outcomes
Urine Albumin-to-Creatinine Ratio (UACR)
Time frame: yearly for 4 years after COVID exposure
Urine protein/creatinine ratio (UPCR)
Time frame: yearly for 4 years after COVID exposure
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 20 Jul 2025.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Evren U. Azeloglu, PhD principal investigator
Icahn School of Medicine at Mount Sinai
5 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-19 and Acute Kidney Injury, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
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 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: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
estimated Glomerular Filtration Rate (eGFR) (time frame: yearly for 4 years after COVID exposure). 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 20 Jul 2025.