Kidney Disease After COVID-19

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Acute Kidney Injury; Chronic Kidney Injury

• Study Type: Observational
• Enrollment (Actual): 1753

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06513
      • Yale School of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School - Rutgers University
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with COVID-19.

Description

Criteria:

Inclusion Criteria:

• Adults, age ≥18 years
• Confirmed diagnosis of COVID-19

Exclusion Criteria:

• No confirmed diagnosis of COVID-19

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
COVID; Patients who have had a confirmed diagnosis of COVID-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	yearly for 4 years after COVID exposure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	yearly for 4 years after COVID exposure

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Johns Hopkins University; University of Michigan; New Jersey Medical School; Yale New Haven Health System Center for Healthcare Solutions
• Investigators: Principal Investigator: Evren U. Azeloglu, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2020
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Renal Insufficiency; COVID-19; Acute Kidney Injury; Wounds and Injuries; Kidney Diseases
• Other Study ID Numbers: STUDY-20-01326; 1300143 (Other Identifier: Renalytix AI, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Specify Other Time FrameData from this study may be requested from other researchers one year after the completion of the primary endpoint by contacting Dr. Evren Azeloglu.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Specify Other Mechanism

1. Any research team who utilizes the data must propose a research question (independent and dependent variable) and post their plan for analysis on a COVID-19 database that is available.
2. All teams need to abide by the requirement that data is analyzed within protected networks and that no data are downloaded or copied.
3. Any data sharing will only occur with the approval with each site PI and only with appropriate regulatory approvals.

Data will be deidentified.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No