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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04407156
Other study ID # UHDB/2020/050
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date July 20, 2020

Study information

Verified date September 2020
Source University Hospitals of Derby and Burton NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

On 31st December 2019, a cluster of pneumonia cases were detected in Hubei province of China where the cause was unclear. The cause for these cases was subsequently identified as a virus which was referred to as SARS-CoV-2, and the associated disease as COVID-19.This evolved rapidly into a global pandemic with first case reported in UK as early as on 30th January 2020. As of 30th April 2020, there have been 3.05 million laboratory confirmed cases world-wide with 161,145 cases in United Kingdom (UK) in 539,768 cases tested for COVID-19. The epidemiology of COVID-19 has differed in China, US and Italy which have different demographic characteristics, testing methods and different ways to curb the spread of infection which can be altered by many things, including behaviour, and the stringent social distancing measure.Though the pandemic started in China, as of 30th April 2020, it has reported only 58.32 cases per million people (pmp) as compared to United kingdom which has reported 2433.8 cases pmp. This has resulted in different epidemiology of COVID-19 and organ system involvement. Lung involvement in the form of alveolar haemorrhages and respiratory failure has been well document in patients with COVID-19 and has been focus of attention, however, other organs are also affected in COVID-19, but there has been limited information kidney involvement in COVID patients.


Recruitment information / eligibility

Status Completed
Enrollment 724
Est. completion date July 20, 2020
Est. primary completion date June 7, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria:

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

1. Adult patients greater or equal to 18 years of age.

2. Swab results available for SARS CoV-19

3. Patients admitted to the hospital as per the national screening criteria

Exclusion Criteria:

The following patients will be excluded from the study

1. Paediatric patients as defined by age of <18 years of age

2. Swab results which are awaited

3. Patients on haemodialysis or peritoneal dialysis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
acute kidney injury
AKI in COVID positive cases

Locations

Country Name City State
United Kingdom Derby Hospital NHS Foundation Trust Derby Derbyshire

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Acute kidney injury in COVID-19 This is the proportion of patients with Acute kidney injury in COVID-19 7 days
Secondary All-cause mortality in AKI patients This is the number of deaths in COVID-19 AKI patients 7 days
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