COVID-19IA-COVAKINCT06471101
Applying Artificial Intelligence to Identify Subphenotypes of Acute Kidney Injury in Mexican Patients With Severe COVID-19
An observational study of COVID-19 and Acute Kidney Injury, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
Trial summary
The goal of this observational study was to identify subphenotypes of acute kidney injury patients with COVID-19, and the investigators analyzed their impact on mortality. The study included demographic and clinical variables of the participants. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- COVID-19, Acute Kidney Injury
- What is being tested?
- clusters
- How many people
- 2,934 participants
- Where
- 1 siteMexico
- Study dates
- 18 Jun 2024to 18 Jun 2024
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute kidney injury and COVID-19
Who may be able to join
- Patients older than 15 years old, hospitalized, and with severe acute respiratory syndrome (SARS-CoV-2) positive confirmation.
Who cannot join
- Patients who did not have at least 1 creatinine measurement.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Enfermedades Respiratorias
Mexico City, 14080
About this study
The goal of this observational study was to identify subphenotypes of acute kidney injury patients with COVID-19, and the investigators analyzed their impact on mortality. The study included demographic and clinical variables of the participants. The implementation of Machine Learning algorithms and Artificial Intelligence methods are used, and some specific implementations were designed for the analysis, where each group was characterized by traditional statistical methods.
- Conditions
- COVID-19, Acute Kidney Injury
- Being tested
- clusters
- Keywords
- machine learning, artificial intelligence
- 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.
clustersDiagnostic test
clustering
What is being measured
The primary outcome is the main question the study is designed to answer.
Subphenotypes of acute kidney injury in patients
Number of acute kidney injury subphenotypes in patients with COVID-19
Measured: Through study completion, an average of one month
Secondary outcomes (5)
Mortality of acute kidney injury patients
Differences between mortality rates in acute kidney injury subphenotypes of patients with COVID-19
Measured: Through study completion, an average of one month
Severity of acute kidney injury patients
Differences between severity stages in acute kidney injury subphenotypes of patients with COVID-19
Measured: Through study completion, an average of one month
Non-recovery in acute kidney injury patients
Differences between non recovery rates in acute kidney injury subphenotypes of patients with COVID-19
Measured: Through study completion, an average of one month
Renal replacement therapy requirement in acute kidney injury patients
Differences between renal replacement therapy requirement rates in acute kidney injury subphenotypes of patients with COVID-19
Measured: Through study completion, an average of one month
Length of stay of acute kidney injury patients
Differences in-hospital length of stay in acute kidney injury subphenotypes of patients with COVID-19.
Measured: Through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start18 Jun 2024
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,934 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Enfermedades Respiratorias
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elizabeth Santiago Del Angel, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471101
- Sponsor's protocol ID
- C38-23
- Acronym
- IA-COVAKI
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Artificial Intelligence to Identify Subphenotypes of Acute Kidney Injury in Mexican Patients With Severe COVID-19
- ClinicalTrials.gov ID
- NCT06471101
- Acronym / sponsor ID
- IA-COVAKI / C38-23
- Conditions
- COVID-19, Acute Kidney Injury
- Keywords
- machine learning, artificial intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,934 participants (actual)
- Lead sponsor
- Instituto Nacional de Enfermedades RespiratoriasOther government
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 24 Jun 2024 (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 goal of this observational study was to identify subphenotypes of acute kidney injury patients with COVID-19, and the investigators analyzed their impact on mortality. The study included demographic and clinical variables of the participants. The implementation of Machine Learning algorithms and Artificial Intelligence methods are used, and some specific implementations were designed for the analysis, where each group was characterized by traditional statistical methods.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute kidney injury and COVID-19
Key inclusion criteria (1 listed)
- Patients older than 15 years old, hospitalized, and with severe acute respiratory syndrome (SARS-CoV-2) positive confirmation.
Key exclusion criteria (1 listed)
- Patients who did not have at least 1 creatinine measurement.
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 |
|---|---|---|
| clustersclustering | Diagnostic test | – |
Primary outcome
Subphenotypes of acute kidney injury in patients
Time frame: Through study completion, an average of one month
Number of acute kidney injury subphenotypes in patients with COVID-19
5 secondary outcomes
Mortality of acute kidney injury patients
Time frame: Through study completion, an average of one month
Severity of acute kidney injury patients
Time frame: Through study completion, an average of one month
Non-recovery in acute kidney injury patients
Time frame: Through study completion, an average of one month
Renal replacement therapy requirement in acute kidney injury patients
Time frame: Through study completion, an average of one month
Length of stay of acute kidney injury patients
Time frame: Through study completion, an average of one month
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 24 Jun 2024.
- 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 Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
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 1 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 24 Jun 2024. 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 Mexico. 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?
Subphenotypes of acute kidney injury in patients (time frame: Through study completion, an average of one month). 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 24 Jun 2024.