NCT04408248

Brief Summary

This research aims to investigate the role of daily measurement of urinary cell cycle arrest markers and other serum and urinary biomarkers to predict the development of acute kidney injury in critically ill patients with COVID-19 and acute respiratory disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

May 27, 2020

Last Update Submit

March 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Any stage of acute kidney injury

    As defined by Kidney Diseases: Improving Global Outcome

    7 days

Secondary Outcomes (4)

  • need for RRT in first 7 days

    7 days

  • Mortality

    7 and 28 days

  • Duration of mechanical ventilation

    7 and 28 days

  • Duration of vasopressor support

    7 and 28 days

Study Arms (1)

COVID-19 patients with acute respiratory disease

Adult patients with COVID-19 and moderate or severe respiratory disease

Eligibility Criteria

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

COVID-19 patients with moderate or severe respiratory disease

You may qualify if:

  • Moderate or severe respiratory disease as defined by Berlin criteria
  • COVID-19 positive
  • Age ≥ 18 years

You may not qualify if:

  • pre-existing AKI
  • severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \<20ml/min
  • end-stage renal failure on regular dialysis
  • kidney transplant within the last 12 months
  • pregnancy
  • breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas' Hospital

London, SE1 7EH, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators will collect blood and urine samples for biomarker measurement at the following time points: at the time point of study inclusion, 12h, 24h, 36h, 48h, 60h, and 72h after inclusion.

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

  • Marlies Ostermann, MD, PhD

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlies Ostermann, MD, PhD

CONTACT

Nuttha Lumlertgul, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 27, 2020

First Posted

May 29, 2020

Study Start

August 20, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations