SARS-CoV InfectionNCT04565782
Corona Virus Infection Among Liver Transplant Recipients
An observational study of SARS-CoV Infection and Corona Virus Infection, run by Assiut University at 1 site in Egypt.
Trial summary
A new strain of coronavirus that caused severe respiratory disease in infected individuals was initially identified in China's Wuhan City in December 2019. Severe acute respiratory distress syndrome coronavirus-2 (SARS-CoV-2), which was responsible for the corona virus infectious disease-2019 (COVID-19).The World… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV Infection, Corona Virus Infection, Liver Transplant Recipient
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2020to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Liver transplant recipients in 3 Liver Transplant Centers in Egypt and who accept to participate in the study.
Who may be able to join
- -Liver transplant recipients in 3 Liver Transplant Centers in Egypt and who accept to participate in the study
Who cannot join
- Those who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut
Nahed Makhlouf, Professor, 01003611626, nahedmak@yahoo.com
Mohamed A Medhat, MD, 01000493632, mmedhat83@gmail.com
About this study
Official title: Corona Virus Infection Among Liver Transplant Recipients: A Multicenter Study
A new strain of coronavirus that caused severe respiratory disease in infected individuals was initially identified in China's Wuhan City in December 2019. Severe acute respiratory distress syndrome coronavirus-2 (SARS-CoV-2), which was responsible for the corona virus infectious disease-2019 (COVID-19).The World Health Organization declared that COVID-19 was a Public Health Emergency of International Concern on January 30,2020.
The impact of COVID-19 in liver recipients remains largely unknown but accumulating experience is going on.
Read more
Liver transplant recipients should have been classified as a risk group and should have received regular surveillance for COVID-19 throughout the pandemic.
Some reports suggest decreasing immunosuppression for infected recipients, if no recent rejection episodes. Paradoxically, others suggest that a reactive immune response might be the cause for severe tissue damage, and that immunosuppression might be protective from the postulated cytokine storm.
Some studies stated that the LT patients who are permanently on immunosuppressants could be particularly susceptible to SARS-CoV-2, and their prognosis could be worse in comparison to the normal population. They recommended that LT recipients should be closely monitored for SARS-CoV-2.
The LT society of India (LTSI) highlighted the potential of LT recipients as asymptomatic carriers and source of viral spread, and that SARS-CoV-2 can be transmitted to LT recipients. There are insufficient data on the relationship between immunosuppressive therapy and COVID-19 in LT recipients during this pandemic. However, the Beijing working party for liver transplantation suggested that LT recipients who were infected with SARS-CoV-2 should be treated with steroids for a short period to reduce the severity of pneumonia.
They also suggested that immunosuppressive therapies should be continued for both patients with mild COVID-19 and those who were not infected by the virus, and calcineurin inhibitor treatment dosage should be reduced in moderate to severe cases.
Neutralizing antibodies (NAbs) play an important role in virus clearance and have been considered as a key immune product for protection or treatment against viral diseases. Virus-specific NAbs, induced through either infection or vaccination, have the ability to block viral infection. SARS-CoV -2 specific NAbs reached their peak in patients from day 10-15 after the onset of the disease and remained stable thereafter in the patients. Antibodies targeting on different domains of S protein, including S1, RBD, and S2, may all contribute to the neutralization.
Al-Rajhi Liver Center is the only liver transplantation center in Upper Egypt that performed only 51 living donor liver transplantation (LDLT) cases since 2014, but it was used as isolation Hospital for COVID-19 cases from March to July, 2020. Communication with liver transplant cases during that period was via Telemedicine. Resuming usual Hospital activity as Tertiary Liver Center occurred in 15 August 2020. Similarly, other Hospitals in Egypt were designated as COVID-19 isolation Hospitals.
Read the detailed description
- Liver Transplant recipients in 3 liver transplant centers will answer survey including 21 questions (14 questions covers the demographic data, date since the operation and immunosuppressant medications and 11 questions related to Corona virus infection). (SARS-CoV-2 infection will be defined according to the Ministry of Health and population definitions of suspected and confirmed cases).
- Doing serological test searching for Neutralizing Ab against SARS-Corona virus 2 in the liver transplant recipients who accepted to give blood sample. (It can be detected by Electrochemiluminescence immunoassay (ECLIA) method.
- Medical subject headings
- Severe Acute Respiratory Syndrome, Coronavirus Infections, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of corona virus infection (confirmed or suspected) among liver transplant recipients
Measured: 1 month
Secondary outcomes (1)
The presence of Neutralizing Ab against SARS-Corona virus 2 among liver transplant recipients whether who give symptoms for corona virus or asymptomatic and who accept to give blood sample
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start15 Sep 2020
- Primary completion1 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nahed A. Makhlouf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565782
- Sponsor's protocol ID
- 17300475
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corona Virus Infection Among Liver Transplant Recipients: A Multicenter Study
- ClinicalTrials.gov ID
- NCT04565782
- Acronym / sponsor ID
- 17300475
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 25 Sep 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.
A new strain of coronavirus that caused severe respiratory disease in infected individuals was initially identified in China's Wuhan City in December 2019. Severe acute respiratory distress syndrome coronavirus-2 (SARS-CoV-2), which was responsible for the corona virus infectious disease-2019 (COVID-19).The World Health Organization declared that COVID-19 was a Public Health Emergency of International Concern on January 30,2020.
The impact of COVID-19 in liver recipients remains largely unknown but accumulating experience is going on.
Liver transplant recipients should have been classified as a risk group and should have received regular surveillance for COVID-19 throughout the pandemic.
Some reports suggest decreasing immunosuppression for infected recipients, if no recent rejection episodes. Paradoxically, others suggest that a reactive immune response might be the cause for severe tissue damage, and that immunosuppression might be protective from the postulated cytokine storm.
Some studies stated that the LT patients who are permanently on immunosuppressants could be particularly susceptible to SARS-CoV-2, and their prognosis could be worse in comparison to the normal population. They recommended that LT recipients should be closely monitored for SARS-CoV-2.
The LT society of India (LTSI) highlighted the potential of LT recipients as asymptomatic carriers and source of viral spread, and that SARS-CoV-2 can be transmitted to LT recipients. There are insufficient data on the relationship between immunosuppressive therapy and COVID-19 in LT recipients during this pandemic. However, the Beijing working party for liver transplantation suggested that LT recipients who were infected with SARS-CoV-2 should be treated with steroids for a short period to reduce the severity of pneumonia.
They also suggested that immunosuppressive therapies should be continued for both patients with mild COVID-19 and those who were not infected by the virus, and calcineurin inhibitor treatment dosage should be reduced in moderate to severe cases.
Neutralizing antibodies (NAbs) play an important role in virus clearance and have been considered as a key immune product for protection or treatment against viral diseases. Virus-specific NAbs, induced through either infection or vaccination, have the ability to block viral infection. SARS-CoV -2 specific NAbs reached their peak in patients from day 10-15 after the onset of the disease and remained stable thereafter in the patients. Antibodies targeting on different domains of S protein, including S1, RBD, and S2, may all contribute to the neutralization.
Al-Rajhi Liver Center is the only liver transplantation center in Upper Egypt that performed only 51 living donor liver transplantation (LDLT) cases since 2014, but it was used as isolation Hospital for COVID-19 cases from March to July, 2020. Communication with liver transplant cases during that period was via Telemedicine. Resuming usual Hospital activity as Tertiary Liver Center occurred in 15 August 2020. Similarly, other Hospitals in Egypt were designated as COVID-19 isolation Hospitals.
Detailed description
- Liver Transplant recipients in 3 liver transplant centers will answer survey including 21 questions (14 questions covers the demographic data, date since the operation and immunosuppressant medications and 11 questions related to Corona virus infection). (SARS-CoV-2 infection will be defined according to the Ministry of Health and population definitions of suspected and confirmed cases).
- Doing serological test searching for Neutralizing Ab against SARS-Corona virus 2 in the liver transplant recipients who accepted to give blood sample. (It can be detected by Electrochemiluminescence immunoassay (ECLIA) method.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Liver transplant recipients in 3 Liver Transplant Centers in Egypt and who accept to participate in the study.
Key inclusion criteria (1 listed)
- -Liver transplant recipients in 3 Liver Transplant Centers in Egypt and who accept to participate in the study
Key exclusion criteria (1 listed)
- Those who refuse to participate in the study.
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
The occurrence of corona virus infection (confirmed or suspected) among liver transplant recipients
Time frame: 1 month
1 secondary outcome
The presence of Neutralizing Ab against SARS-Corona virus 2 among liver transplant recipients whether who give symptoms for corona virus or asymptomatic and who accept to give blood sample
Time frame: 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
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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.
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 SARS-CoV Infection and Corona Virus Infection, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 25 Sep 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of corona virus infection (confirmed or suspected) among liver transplant recipients (time frame: 1 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 25 Sep 2020.