Clinical trial NCT04407156: Epidemiology of Acute Kidney Injury in COVID19 Disease in United Kingdom
Official title: Acute Kidney Injury In Corona Virus Infection Disease (COVID19) in United Kingdom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
AKI
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 724
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is hospitalised patients suspected to have SARS CoV-2 infection

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Acute kidney injury in COVID-19
timeFrame: 7 days
Secondary outcomes:
measure: All-cause mortality in AKI patients
timeFrame: 7 days
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Derby Hospital NHS Foundation Trust
state: Derbyshire
Study officials:
affiliation: University Hospitals of Derby and Burton
name: Nitin V Kolhe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.