Kidney Disease After COVID-19

Active, not recruiting

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

• Registration Number: NCT05328986
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-04
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

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

Exclusion Criteria

• No confirmed diagnosis of COVID-19

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
estimated Glomerular Filtration Rate (eGFR)	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.

Secondary Outcome Measures

Name	Time	Method
Urine Albumin-to-Creatinine Ratio (UACR)	yearly for 4 years after COVID exposure	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.
Urine protein/creatinine ratio (UPCR)	yearly for 4 years after COVID exposure	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

Trial Locations

Locations (5)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

New Jersey Medical School - Rutgers University; 🇺🇸 Newark, New Jersey, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States