Liver DiseasesNCT05167305
The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease
An observational study of Liver Diseases, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Hospital record of the patients of liver disease admitted from April-May 2021 and April-May 2019 will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- This is an observational study
- How many people
- 1,316 participants
- Where
- 1 siteIndia
- Study dates
- 22 Dec 2021to 31 Dec 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of liver disease without COVID-19 infection admitted in the time period April- May 2021 and April-May 2019.
Who may be able to join
- Patients of liver disease requiring hospital admission
Who cannot join
- Active COVID-19 infection at time of admission or acquiring during hospital stay.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease-A Record Based Cross-Sectional Study.
Hospital record of the patients of liver disease admitted from April-May 2021 and April-May 2019 will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and the subsequent 30 d and 90 day readmission rate.
Monitoring and assessment: Hospital records of all patients of liver disease needing admission during the April-May 2019 and 2021, but without active COVID-19 infection, will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and 30 d and 90 d readmission rate.
- Conditions
- Liver Diseases
- Being tested
- This is an observational study
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational studyOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| liver disease without COVID-19 infection-April-May 2019 | Not described Receives: Other: This is an observational study | |
| liver disease without COVID-19 infection -April- May 2021 | Not described Receives: Other: This is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of in-hospital mortality rate of patients of liver disease admitted in April-May 2021 and April-May 2019.
Measured: Until discharge or death
Secondary outcomes (3)
Comparison of 30 days readmission rate of patients of liver disease.
Measured: Day 30
Comparison of 31 to 90 days readmission rate of patients of liver disease.
Measured: Day 31-90
Comparison of liver transplantation rates in the two time periods i.e., April-May 2021 and April-May 2019.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start22 Dec 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 1,316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167305
- Sponsor's protocol ID
- ILBS-COVID-07
- Status last verified
- Dec 2021
- First submitted
- 17 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease-A Record Based Cross-Sectional Study.
- ClinicalTrials.gov ID
- NCT05167305
- Acronym / sponsor ID
- ILBS-COVID-07
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,316 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Dec 2021 (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.
Hospital record of the patients of liver disease admitted from April-May 2021 and April-May 2019 will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and the subsequent 30 d and 90 day readmission rate.
Monitoring and assessment: Hospital records of all patients of liver disease needing admission during the April-May 2019 and 2021, but without active COVID-19 infection, will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and 30 d and 90 d readmission rate.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liver disease without COVID-19 infection-April-May 2019 | – | Other: This is an observational study |
| liver disease without COVID-19 infection -April- May 2021 | – | Other: This is an observational study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of liver disease without COVID-19 infection admitted in the time period April- May 2021 and April-May 2019.
Key inclusion criteria (1 listed)
- Patients of liver disease requiring hospital admission
Key exclusion criteria (1 listed)
- Active COVID-19 infection at time of admission or acquiring during hospital stay.
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 |
|---|---|---|
| This is an observational studyThis is an observational study | Other | liver disease without COVID-19 infection -April- May 2021, liver disease without COVID-19 infection-April-May 2019 |
Primary outcome
Comparison of in-hospital mortality rate of patients of liver disease admitted in April-May 2021 and April-May 2019.
Time frame: Until discharge or death
3 secondary outcomes
Comparison of 30 days readmission rate of patients of liver disease.
Time frame: Day 30
Comparison of 31 to 90 days readmission rate of patients of liver disease.
Time frame: Day 31-90
Comparison of liver transplantation rates in the two time periods i.e., April-May 2021 and April-May 2019.
Time frame: 3 months
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 4 Jan 2022.
- Individual participant dataSharing planned: No
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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 Liver Diseases, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 4 Jan 2022. 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 India. 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?
Comparison of in-hospital mortality rate of patients of liver disease admitted in April-May 2021 and April-May 2019. (time frame: Until discharge or death). 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 4 Jan 2022.