COVID-19NCT04316299
Acute Kidney Injury in Patients Hospitalized With COVID-19
An observational study of COVID-19 and Acute Kidney Injury, run by Zhenhua Zen at 1 site in China.
Trial summary
The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Acute Kidney Injury, Kidney Function
- How many people
- 287 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2020to 8 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Hankou Hospital in Wuhan with confirmed COVID-19 pneumonia from 5th Jan to 28th Feb.
Who may be able to join
- COVID-19 pneumonia patients diagnosed by WHO criteria
Who cannot join
- Patients who were younger than 18 years,
- Patients who had undergone renal replacement therapy (RRT) before admission,
- Patients whose entire stay lasted for less than 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Kidney Injury in Patients Hospitalized With COVID-19 in Wuhan, China: a Single-center Retrospective Observational Study
The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19.
- Conditions
- COVID-19, Acute Kidney Injury, Kidney Function
- Medical subject headings
- COVID-19, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AKI | COVID-19 patients with acute kidney injury | |
| non-AKI | COVID-19 patients without acute kidney injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Acute Kidney Injury
the incidence of Acute Kidney Injury
Measured: From date of admission until the date of discharge or death from any cause, up to 60 days
Secondary outcomes (2)
Rate of Death
death from any cause in the hospital
Measured: From date of admission until the date of death from any cause, up to 60 days
the length of hospital stay
days from admission to discharge or death
Measured: From date of admission until the date of discharge or death from any cause, up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start26 Feb 2020
- Primary completion28 Feb 2020
- Study completion8 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhenhua Zen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhenhua Zen, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316299
- Sponsor's protocol ID
- hkyy2020-005 AKI
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury in Patients Hospitalized With COVID-19 in Wuhan, China: a Single-center Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT04316299
- Acronym / sponsor ID
- hkyy2020-005 AKI
- Conditions
- COVID-19, Acute Kidney Injury, Kidney Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Zhenhua ZenUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 8 Mar 2020 (actual)
- First posted
- 20 Mar 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.
The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI | – | –COVID-19 patients with acute kidney injury |
| non-AKI | – | –COVID-19 patients without acute kidney injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Hankou Hospital in Wuhan with confirmed COVID-19 pneumonia from 5th Jan to 28th Feb.
Key inclusion criteria (1 listed)
- COVID-19 pneumonia patients diagnosed by WHO criteria
Key exclusion criteria (3 listed)
- Patients who were younger than 18 years,
- Patients who had undergone renal replacement therapy (RRT) before admission,
- Patients whose entire stay lasted for less than 48 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Acute Kidney Injury
Time frame: From date of admission until the date of discharge or death from any cause, up to 60 days
the incidence of Acute Kidney Injury
2 secondary outcomes
Rate of Death
Time frame: From date of admission until the date of death from any cause, up to 60 days
the length of hospital stay
Time frame: From date of admission until the date of discharge or death from any cause, up to 60 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 30 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-19 and Acute Kidney Injury, run by Zhenhua Zen at 1 site in China.
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 1 inclusion and 3 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 30 Mar 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 China. 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?
Rate of Acute Kidney Injury (time frame: From date of admission until the date of discharge or death from any cause, up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2020.