Covid19NCT04695756
Liver Transplantation and Coronavirus Disease 2019 (COVID-19)
An observational study of Covid19 and Liver Transplant, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The COVID-19 pandemic together with the strategies that are applied to control it are generating high morbidity and mortality worldwide. Its impact on health systems is worrisome, affecting all the population, even those who are not infected or at risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Liver Transplant
- What is being tested?
- COVID-19 pandemic
- How many people
- 1,000 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Dec 2020to 15 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a population-based study. The study population is the Argentine population. Regarding the patients, those who are registered on the national waiting list for isolated liver transplantation will be included.
Who may be able to join
- Age > 17 years-old
- Argentinean
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, 1643
Sebastián Marciano, MD, MsC, 1150066086, sebastian.marciano@hospitalitaliano.org.ar
About this study
Official title: Impact of Coronavirus Disease 2019 (COVID-19) Epidemic in Patients Requiring Liver Transplantation
The COVID-19 pandemic together with the strategies that are applied to control it are generating high morbidity and mortality worldwide. Its impact on health systems is worrisome, affecting all the population, even those who are not infected or at risk.
The indirect impact of the COVID-19 pandemic on the access to the medical care of patients on the waiting list for organ transplantation might be multifactorial, including the need to relocate health-related resources (medical personnel, supplies, critical care unit beds, etc), the risk of COVID-19 transmission among donors or patients on the waiting list, and also after transplantation. Additionally, the pandemic reduces significantly the donor pool.
Read more
We consider that it is important to assess the impact that the pandemic has in particular individual populations, such as in patients requiring a liver transplant. Along with the lockdown, the rate of organ donation has dropped, and liver transplant programs across the world have reduced or suspended their activity. Unfortunately, this is invariably associated with an increase in mortality on the waiting list.
Knowing the impact of the pandemic on patients who require a liver transplant will provide tools to understand and plan the health resources related to the care of these patients, not only at present but also in the following years.
Read the detailed description
The COVID-19 pandemic together with the strategies that are applied to control it is generating high morbidity and mortality worldwide. Its impact on health systems is worrisome, affecting all the population, even those who are not infected or at risk.
The indirect impact of the COVID-19 pandemic on the access to the medical care of patients on the waiting list for organ transplantation might be multifactorial, including the need to relocate health-related resources (medical personnel, supplies, critical care unit beds, etc), the risk of COVID-19 transmission among donors or patients on the waiting list, and also after transplantation. Additionally, the pandemic reduces significantly the donor pool.
We consider that it is important to assess the impact that the pandemic has in particular individual populations, such as in patients requiring a liver transplant. Along with the lockdown, the rate of organ donation has dropped, and liver transplant programs across the world have reduced or suspended their activity. Unfortunately, this is invariably associated with an increase in mortality on the waiting list.
Knowing the impact of the pandemic on patients who require a liver transplant will provide tools to understand and plan the health resources related to the care of these patients, not only at present but also in the following years.
The primary objectives of the study will be
To Compare the following outcomes in patients requiring liver transplantation during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation:
- Number of patients registered on the liver transplant waiting list
- Number of deaths on the liver transplant waiting list
- Number of liver transplants
For this purpose, we will carry out a time series analyses using the national data registry of procurement and transplantation database. The effect of both periods will be analysed as time interrupted series, which is a quasi-experimental design. The following two periods will be compared as segments of the interrupted time series:
- Baseline period (Period not exposed to the pandemic represented by the same epidemiological weeks of 2019 )
- Pandemic period COVID-19. (Period between the epidemiological weeks of 2020 affected by the pandemic declared by the WHO from 11/March/2020)
The unit of analysis will be the epidemiological weeks, and the study population will be all Argentinian over 17 years of age. Regarding patients who require liver transplantation, those who registered for isolated liver transplantation in the National Procurement and Transplant Institute will be included.
A Poisson regression model will be used to assess the association between the period and the incidence of the events of interest. ARIMA models will be used following the 4 steps proposed by Box and Jenkings
- Conditions
- Covid19, Liver Transplant
- Being tested
- COVID-19 pandemic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 pandemicOther
The exposure of this observational study is the COVID-19 pandemic
| Study group | Role | What they receive |
|---|---|---|
| People who require liver transplant | We will compare the year before the beginning of the COVID-19 Pandemia with the period during the COVID-19 Pandemia. Receives: Other: COVID-19 pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the number of patients registered on the liver transplant waiting list during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation
During the study period, patients who are registered on the transplant waiting list will be included. The data source will be the national transplant database.
Measured: 1 year
Secondary outcomes (2)
To compare the number of deaths on the liver transplant waiting list during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation
During the study period, patients who die on the transplant waiting list will be registered. The data source will be the national transplant database.
Measured: 1 year
To compare the number of liver transplants during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation
During the study period, the number of liver transplants who are performed will be registered. The data source will be the national transplant database.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Dec 2020
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- National Agency for Scientific and Technological Promotion, Argentina
- Responsible party
- Principal investigator, Diego Hernan Giunta, PhD, MPH, MD, Hospital Italiano de Buenos Aires
- Investigators
- Sebastián Marciano, MS, Msc, Study chair, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695756
- Sponsor's protocol ID
- 1405
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Coronavirus Disease 2019 (COVID-19) Epidemic in Patients Requiring Liver Transplantation
- ClinicalTrials.gov ID
- NCT04695756
- Acronym / sponsor ID
- 1405
- Conditions
- Covid19, Liver Transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- National Agency for Scientific and Technological Promotion, Argentina
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 5 Jan 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.
The COVID-19 pandemic together with the strategies that are applied to control it are generating high morbidity and mortality worldwide. Its impact on health systems is worrisome, affecting all the population, even those who are not infected or at risk.
The indirect impact of the COVID-19 pandemic on the access to the medical care of patients on the waiting list for organ transplantation might be multifactorial, including the need to relocate health-related resources (medical personnel, supplies, critical care unit beds, etc), the risk of COVID-19 transmission among donors or patients on the waiting list, and also after transplantation. Additionally, the pandemic reduces significantly the donor pool.
We consider that it is important to assess the impact that the pandemic has in particular individual populations, such as in patients requiring a liver transplant. Along with the lockdown, the rate of organ donation has dropped, and liver transplant programs across the world have reduced or suspended their activity. Unfortunately, this is invariably associated with an increase in mortality on the waiting list.
Knowing the impact of the pandemic on patients who require a liver transplant will provide tools to understand and plan the health resources related to the care of these patients, not only at present but also in the following years.
Detailed description
The COVID-19 pandemic together with the strategies that are applied to control it is generating high morbidity and mortality worldwide. Its impact on health systems is worrisome, affecting all the population, even those who are not infected or at risk.
The indirect impact of the COVID-19 pandemic on the access to the medical care of patients on the waiting list for organ transplantation might be multifactorial, including the need to relocate health-related resources (medical personnel, supplies, critical care unit beds, etc), the risk of COVID-19 transmission among donors or patients on the waiting list, and also after transplantation. Additionally, the pandemic reduces significantly the donor pool.
We consider that it is important to assess the impact that the pandemic has in particular individual populations, such as in patients requiring a liver transplant. Along with the lockdown, the rate of organ donation has dropped, and liver transplant programs across the world have reduced or suspended their activity. Unfortunately, this is invariably associated with an increase in mortality on the waiting list.
Knowing the impact of the pandemic on patients who require a liver transplant will provide tools to understand and plan the health resources related to the care of these patients, not only at present but also in the following years.
The primary objectives of the study will be
To Compare the following outcomes in patients requiring liver transplantation during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation:
- Number of patients registered on the liver transplant waiting list
- Number of deaths on the liver transplant waiting list
- Number of liver transplants
For this purpose, we will carry out a time series analyses using the national data registry of procurement and transplantation database. The effect of both periods will be analysed as time interrupted series, which is a quasi-experimental design. The following two periods will be compared as segments of the interrupted time series:
- Baseline period (Period not exposed to the pandemic represented by the same epidemiological weeks of 2019 )
- Pandemic period COVID-19. (Period between the epidemiological weeks of 2020 affected by the pandemic declared by the WHO from 11/March/2020)
The unit of analysis will be the epidemiological weeks, and the study population will be all Argentinian over 17 years of age. Regarding patients who require liver transplantation, those who registered for isolated liver transplantation in the National Procurement and Transplant Institute will be included.
A Poisson regression model will be used to assess the association between the period and the incidence of the events of interest. ARIMA models will be used following the 4 steps proposed by Box and Jenkings
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People who require liver transplant | – | Other: COVID-19 pandemicWe will compare the year before the beginning of the COVID-19 Pandemia with the period during the COVID-19 Pandemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a population-based study. The study population is the Argentine population. Regarding the patients, those who are registered on the national waiting list for isolated liver transplantation will be included.
Key inclusion criteria (2 listed)
- Age > 17 years-old
- Argentinean
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| COVID-19 pandemicThe exposure of this observational study is the COVID-19 pandemic | Other | People who require liver transplant |
Primary outcome
To compare the number of patients registered on the liver transplant waiting list during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation
Time frame: 1 year
During the study period, patients who are registered on the transplant waiting list will be included. The data source will be the national transplant database.
2 secondary outcomes
To compare the number of deaths on the liver transplant waiting list during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation
Time frame: 1 year
To compare the number of liver transplants during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Sebastián Marciano, MS, Msc study chair
Hospital Italiano de Buenos Aires
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 Covid19 and Liver Transplant, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Jan 2021. 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 Argentina. 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 Sebastián Marciano, MD, MSc (01150066086, sebastian.marciano@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the number of patients registered on the liver transplant waiting list during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation (time frame: 1 year). 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 12 Jan 2021.