NCT04316299

Brief Summary

The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

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

Study Start

First participant enrolled

February 26, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

2 days

First QC Date

March 17, 2020

Last Update Submit

March 26, 2020

Conditions

COVID-19Acute Kidney InjuryKidney Function

Outcome Measures

Primary Outcomes (1)

  • Rate of Acute Kidney Injury

    the incidence of Acute Kidney Injury

    From date of admission until the date of discharge or death from any cause, up to 60 days

Secondary Outcomes (2)

  • Rate of Death

    From date of admission until the date of death from any cause, up to 60 days

  • the length of hospital stay

    From date of admission until the date of discharge or death from any cause, up to 60 days

Study Arms (2)

AKI

COVID-19 patients with acute kidney injury

non-AKI

COVID-19 patients without acute kidney injury

Eligibility Criteria

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

Patients admitted to Hankou Hospital in Wuhan with confirmed COVID-19 pneumonia from 5th Jan to 28th Feb.

You may qualify if:

  • COVID-19 pneumonia patients diagnosed by WHO criteria

You may not qualify if:

  • Patients who were younger than 18 years,
  • Patients who had undergone renal replacement therapy (RRT) before admission,
  • Patients whose entire stay lasted for less than 48 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hankou Hospital

Wuhan, Hubei, 430000, China

Location

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 Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 20, 2020

Study Start

February 26, 2020

Primary Completion

February 28, 2020

Study Completion

March 8, 2020

Last Updated

March 30, 2020

Record last verified: 2020-03

Locations

CN(1)