COVID-19NCT04422379
COVID-19 and Liver Injury in Patients With or Without Underlying Liver Disease: A Multi-centre Retrospective-prospective Observational Study
An observational study of COVID-19, run by Max Healthcare Insititute Limited at 1 site in India.
Trial summary
COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study. All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- How many people
- 314 participants
- Where
- 1 siteIndia
- Study dates
- 7 Jun 2020to 30 Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include all the COVID 19 patients (male \& female) with minimum age 18 years old. And take 60% patient in Retrospective arm and 40% patient in prospective arm.
Who may be able to join
None listed.
Who cannot join
- Patients less that 18 years old with COVID-19
- Pregnant ladies with COVD-19
- Unwilling to give consent for inclusion
Trial locations and contacts
1 site in 1 country.
India1 site
Max Super Speciality Hospital, Saket (A Unit Of Devki Devi Foundation)
New Delhi, Dlelhi, 110017
Rajesh Saxena, 9818474003, Rajesh.saxena@maxhealthcare.com
About this study
COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study.
All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included
Read the detailed description
COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study.
All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included Primary objectives
- To study the prevalence of liver live injury \& factors associated with among patients in-fected with SARS-CoV-2.
- To study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops COVD-19.
Secondary objectives
- To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients.
- To define the incidence of development of acute liver failure among these patients
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Positive Case
To study the prevalence of liver live injury \& factors associated with among patients in-fected with SARS-CoV-2.
Measured: 4-8 weeks
COVID-19 Positive Case
To study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops COVID-19.
Measured: 4-8 weeks
Secondary outcomes (2)
COVID-19 Positive Case
To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients.
Measured: 4-8 weeks
COVID-19 Positive Case
To define the incidence of development of acute liver failure among these patients
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start7 Jun 2020 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
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
- Other
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaushal Madan, DM, Principal investigator, Max healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422379
- Sponsor's protocol ID
- COVID 19/LI/2020
- Status last verified
- Jun 2020
- First submitted
- 7 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Liver Injury in Patients With or Without Underlying Liver Disease: A Multi-centre Retrospective-prospective Observational Study
- ClinicalTrials.gov ID
- NCT04422379
- Acronym / sponsor ID
- COVID 19/LI/2020
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 7 Jun 2020 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 9 Jun 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.
COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study.
All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included
Detailed description
COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study.
All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included Primary objectives
- To study the prevalence of liver live injury \& factors associated with among patients in-fected with SARS-CoV-2.
- To study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops COVD-19.
Secondary objectives
- To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients.
- To define the incidence of development of acute liver failure among these patients
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all the COVID 19 patients (male \& female) with minimum age 18 years old. And take 60% patient in Retrospective arm and 40% patient in prospective arm.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients less that 18 years old with COVID-19
- Pregnant ladies with COVD-19
- Unwilling to give consent for inclusion
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
COVID-19 Positive Case
Time frame: 4-8 weeks
To study the prevalence of liver live injury \& factors associated with among patients in-fected with SARS-CoV-2.
COVID-19 Positive Case
Time frame: 4-8 weeks
To study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops COVID-19.
2 secondary outcomes
COVID-19 Positive Case
Time frame: 4-8 weeks
COVID-19 Positive Case
Time frame: 4-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Undecided. IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.
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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.
Kaushal Madan, DM principal investigator
Max healthcare
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, run by Max Healthcare Insititute Limited 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 0 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: status not confirmed, as of the sponsor's last update on 9 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaushal Madan, DM (9958787720, K_madan_2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Positive Case (time frame: 4-8 weeks). The study lists 2 primary outcomes in all. 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 9 Jun 2020.