NCT04583293

Brief Summary

This is a prospective observational parallel group cohort study that will aim to recruit 220 participants who were admitted to the hospital with COVID-19 between 1st March 2020 and 30th June 2020 (Group A - 110 participants who had COVID-19 with AKI; Group B - 110 participants who had COVID-19 without AKI). Data from groups A and B will be compared with AKI and non-AKI groups from an existing study database (ARID study, n=1125) who were recruited before the outbreak of the COVID-19 pandemic (recruitment 2013-2016) and who have all completed at least three years of follow up. Participants who have recovered from COVID-19 will be matched for analysis to participants from the ARID study for AKI status, baseline estimated glomerular filtration rate (eGFR) stage, age (± 5 years) and presence of diabetes. Potential participants will receive a letter of invitation along with a comprehensive participant information sheet (PIS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration 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

October 6, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

3.3 years

First QC Date

October 6, 2020

Last Update Submit

March 18, 2025

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Incidence of kidney disease progression at 12 months.

    Kidney disease progression will be defined as a decline in estimated glomerular filtration rate (eGFR; ml/min/1.73m2) of ≥30%

    12 months after hospital discharge.

Secondary Outcomes (8)

  • Incidence of albuminuria at 6-9 months.

    6-9 months after hospital discharge.

  • Incidence of albuminuria at 12-15 months.

    12-15 months after hospital discharge.

  • Incidence of combined kidney disease progression and albuminuria at 6-9 months.

    6-9 months after hospital discharge.

  • Incidence of combined kidney disease progression and albuminuria at 12-15 months.

    12-15 months after hospital discharge.

  • Factors associated with all-cause mortality at 6-9 months.

    6-9 months after hospital discharge.

  • +3 more secondary outcomes

Study Arms (2)

COVID AKI

Participants who were admitted to the hospital with COVID-19 and developed AKI during their hospital stay.

Other: No intervention

COVID non-AKI

Participants who were admitted to the hospital with COVID-19 and did not develop AKI during their hospital stay.

Other: No intervention

Interventions

No interventionOTHER

This study does not involve any intervention or new treatment.

COVID AKICOVID non-AKI

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who were admitted to the hospital with COVID-19: * Group A: people who had COVID-19 with AKI. * Group B: people who had COVID-19 without AKI.

You may qualify if:

  • Adult patients greater or equal to 18 years of age.
  • Swab results positive for SARS-CoV-2.
  • Patients admitted to the hospital for ≥24hrs.

You may not qualify if:

  • Paediatric patients as defined by age of \<18 years of age.
  • Patients \>90 years of age.
  • Swab results negative for SARS-CoV-2.
  • Patients on haemodialysis or peritoneal dialysis, pre-existing CKD stage 5 (eGFR \<15ml/min/1.73m2), solid organ transplant.
  • Inability/refusal to give informed consent to participate.
  • Death during the same hospital admission that AKI occurred.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Nitin V Kolhe, Doctor

    University Hospitals of Derby and Burton NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 12, 2020

Study Start

October 8, 2020

Primary Completion

January 25, 2024

Study Completion

January 25, 2024

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)