NCT04565782

Corona Virus Infection Among Liver Transplant Recipients

Status unknown Last updated 25 September 2020

What this trial tests

trial in SARS-CoV Infection in 150 participants. Status unknown.

Timeline

15 September 2020

Primary endpoint
1 November 2020

31 December 2020

Quick facts

Lead sponsor	Assiut University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	150
Start date	15 September 2020
Primary completion	1 November 2020
Estimated completion	31 December 2020
Sites	1 location across Egypt

Conditions studied

• SARS-CoV Infection — all drugs for SARS-CoV Infection →
• Corona Virus Infection — all drugs for Corona Virus Infection →
• Liver Transplant Recipient — all drugs for Liver Transplant Recipient →
• COVID-19 — all drugs for COVID-19 →

Sponsor

Assiut University

Who can join

Eligibility, any sex, with SARS-CoV Infection or Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.