NCT05328986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,753

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

April 13, 2022

Last Update Submit

July 16, 2025

Conditions

COVID-19Acute Kidney InjuryChronic Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Urine Albumin-to-Creatinine Ratio (UACR)

    yearly for 4 years after COVID exposure

  • Urine protein/creatinine ratio (UPCR)

    yearly for 4 years after COVID exposure

Study Arms (1)

COVID

Patients who have had a confirmed diagnosis of COVID-19.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COVID-19.

You may qualify if:

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

You may not qualify if:

  • No confirmed diagnosis of COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Yale School of Medicine

New Haven, Connecticut, 06513, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

New Jersey Medical School - Rutgers University

Newark, New Jersey, 07103, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of blood and urine samples.

MeSH Terms

Conditions

COVID-19Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Evren U. Azeloglu, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 14, 2022

Study Start

January 4, 2020

Primary Completion

January 4, 2024

Study Completion

January 4, 2024

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, CSR
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.
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.

Locations

US(5)