COVIDNCT04407156
Epidemiology of Acute Kidney Injury in COVID19 Disease in United Kingdom
An observational study of COVID and AKI, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- What is being tested?
- acute kidney injury
- How many people
- 724 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2020to 20 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is hospitalised patients suspected to have SARS CoV-2 infection
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Derby Hospital NHS Foundation Trust
Derby, Derbyshire, DE22 3NE
About this study
Official title: Acute Kidney Injury In Corona Virus Infection Disease (COVID19) in United Kingdom
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.
Read the 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.
- Being tested
- acute kidney injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute kidney injuryOther
AKI in COVID positive cases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute kidney injury in COVID-19
This is the proportion of patients with Acute kidney injury in COVID-19
Measured: 7 days
Secondary outcomes (1)
All-cause mortality in AKI patients
This is the number of deaths in COVID-19 AKI patients
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jun 2020
- Primary completion7 Jun 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitin V Kolhe, MD, Principal investigator, University Hospitals of Derby and Burton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407156
- Sponsor's protocol ID
- UHDB/2020/050
- Status last verified
- Sep 2020
- First submitted
- 6 May 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results will be shared with other researchers
Publications
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.
PubMed 33125416
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury In Corona Virus Infection Disease (COVID19) in United Kingdom
- ClinicalTrials.gov ID
- NCT04407156
- Acronym / sponsor ID
- UHDB/2020/050
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 7 Jun 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is hospitalised patients suspected to have SARS CoV-2 infection
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acute kidney injuryAKI in COVID positive cases | Other | – |
Primary outcome
Incidence of Acute kidney injury in COVID-19
Time frame: 7 days
This is the proportion of patients with Acute kidney injury in COVID-19
1 secondary outcome
All-cause mortality in AKI patients
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 33125416Kolhe 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.
- Individual participant dataSharing planned: No. The results will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin V Kolhe, MD principal investigator
University Hospitals of Derby and Burton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and AKI, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute kidney injury in COVID-19 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04407156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.