NCT04407156

Brief Summary

Severe Acute respiratory syndrome coronovirus (SARS-CoV-2) was first described in Wuhan in December 2019. It quickly spread to rest of the world and was declared pandemic by World health organisation. Initial case series focused on lung involvement in the form alveolar haemorrhages and respiratory failure. However, subsequently, there have been reports of kidney involvement resulting in severe acute kidney injury. However, the reported incidence from Chinese data has been less than 5% and detailed epidemiology of AKI in COVID-19 disease is lacking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
724

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 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

May 6, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

6 days

First QC Date

May 6, 2020

Last Update Submit

September 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Acute kidney injury in COVID-19

    This is the proportion of patients with Acute kidney injury in COVID-19

    7 days

Secondary Outcomes (1)

  • All-cause mortality in AKI patients

    7 days

Interventions

AKI in COVID positive cases

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is hospitalised patients suspected to have SARS CoV-2 infection

You may qualify if:

  • All patients who are admitted to the hospital with suspected COVID-19 infection between 1st March 2020 and 8th May 2020 and who meet following criteria will be included
  • Adult patients greater or equal to 18 years of age.
  • Swab results available for SARS CoV-19
  • Patients admitted to the hospital as per the national screening criteria

You may not qualify if:

  • The following patients will be excluded from the study
  • Paediatric patients as defined by age of \<18 years of age
  • Swab results which are awaited
  • Patients on haemodialysis or peritoneal dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derby Hospital NHS Foundation Trust

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

Related Publications (1)

  • Kolhe NV, Fluck RJ, Selby NM, Taal MW. Acute kidney injury associated with COVID-19: A retrospective cohort study. PLoS Med. 2020 Oct 30;17(10):e1003406. doi: 10.1371/journal.pmed.1003406. eCollection 2020 Oct.

Study Officials

  • Nitin V Kolhe, MD

    University Hospitals of Derby and Burton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 29, 2020

Study Start

June 1, 2020

Primary Completion

June 7, 2020

Study Completion

July 20, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

The results will be shared with other researchers

Locations