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NCT05328986 Clinical Trial

Kidney Disease After COVID-19

COVID-19 Clinical Trial

Official title:
Multi-center Assessment of Survivors for Kidney Disease After COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05328986
Other study ID # STUDY-20-01326
Secondary ID 1300143
Status Active, not recruiting
Phase
First received
Last updated
Start date January 4, 2020
Est. completion date January 2025

Study information
Verified date March 2024
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 3000
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Criteria: Inclusion Criteria: - Adults, age =18 years - Confirmed diagnosis of COVID-19 Exclusion Criteria: • No confirmed diagnosis of COVID-19

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Johns Hopkins University Baltimore Maryland
United States Yale School of Medicine New Haven Connecticut
United States Icahn School of Medicine at Mount Sinai New York New York
United States New Jersey Medical School - Rutgers University Newark New Jersey

Sponsors (5)
Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai Johns Hopkins University, New Jersey Medical School, University of Michigan, Yale New Haven Health System Center for Healthcare Solutions

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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