NCT04353583

Brief Summary

Acute kidney injury (AKI) has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of AKI and renal recovery of inpatients diagnosed with COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 6, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 21, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2022

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

April 6, 2020

Last Update Submit

March 3, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Incidence of AKI

    Serial assessment of serum creatinine and urine output

    30 days post-hospital admission

  • Cystatin C as indicator of mortality

    All-cause mortality

    30 days post-hospital admission

  • Cystatin C as indicator of renal disease

    AKI and acute kidney disease (AKD)

    30 days post-hospital admission

  • Cystatin C as indicator of respiratory illness

    Ventilator-free days

    30 days post-hospital admission

  • Cystatin C as indicator of disease severity

    Rate of intensive care unit admission

    30 days post-hospital admission

Study Arms (2)

ICU patients

Inpatients with COVID-19 requiring ICU care

Non-ICU patients

Inpatients with COVID-19 not requiring ICU care

Eligibility Criteria

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

Hospitalized patients with diagnosed COVID-19

You may qualify if:

  • \) Patients with COVID-19 diagnosed by World Health Organisation (WHO) criteria

You may not qualify if:

  • Patients aged less than 18 years
  • Patients with stage 4 chronic kidney disease (baseline estimated glomerular filtration rate \<30 ml/min/1.73 m2)
  • Patients receiving maintenance dialysis
  • Recipients of solid-organ transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Giessen and Marburg, Giessen

Giessen, Hesse, 35382, Germany

Location

Related Publications (1)

  • Naicker S, Yang CW, Hwang SJ, Liu BC, Chen JH, Jha V. The Novel Coronavirus 2019 epidemic and kidneys. Kidney Int. 2020 May;97(5):824-828. doi: 10.1016/j.kint.2020.03.001. Epub 2020 Mar 7. No abstract available.

MeSH Terms

Conditions

Acute Kidney InjuryCoronavirus Infections

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Werner Seeger, MD

    University Hospital Giessen and Marburg, Giessen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 20, 2020

Study Start

April 21, 2020

Primary Completion

May 17, 2022

Study Completion

February 1, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations