COVID-19 Clinical Trial
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.
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.
1. 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).
2. 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.
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