AASLD has endorsed Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion, or SECURE-Liver Registry, an international initiative that allows clinicians to submit cases of patients with liver disease or prior liver transplant and COVID-19.
“SECURE-Liver Registry aims to better understand the risk factors and outcomes of COVID-19 in patients with liver disease and quickly make this information available to clinicians and patients,” said Andrew M. Moon, MD, MPH, Transplant Hepatology Fellow at University of North Carolina at Chapel Hill (UNC). Dr. Moon developed the registry with A. Sid Barritt IV, MD, MSCR, Director of Hepatology at UNC.
Any provider or clinician who cares for patients with liver disease can submit a lab-confirmed case of COVID-19 in a patient with chronic liver disease or prior liver transplantation via the online form found here. All of the data collected is de-identified in accordance with HIPAA Safe Harbor De-Identification standards.
The case report form, which takes about five minutes to fill out, requests information to further the understanding of the interplay of COVID-19 and liver disease and is adapted as this understanding evolves. Questions have been added pertaining to patterns and treatment of COVID-related blood clots, novel SARS-CoV-2 variants, and the pattern of post-vaccination infections.
“AASLD members who submit will benefit by helping to improve our understanding of these emerging questions and many others,” Dr. Moon said. Additionally, those who submit several cases will have the opportunity to be coauthors on future manuscripts and presentations.
Originally called SECURE-Cirrhosis, the registry was renamed in March of this year to better reflect its mission to collect data on patients with liver transplant and non-cirrhotic chronic liver diseases.
“We really wanted to encourage individuals to submit cases of COVID-19 among patients without cirrhosis but with underlying viral hepatitis, fatty liver, alcohol-associated liver disease, or any other cause of chronic liver disease,” Dr. Moon said.
SECURE-Liver collaborates with the European Association for the Study of the Liver (EASL) COVID-Hep Registry. SECURE-Liver collects case reports from North America, South America, China, Japan, and Korea, while COVID-Hep collects case reports from elsewhere in the world.
“COVID-Hep was launched in the University of Oxford in the United Kingdom, and we realized that our efforts would be more impactful if we worked together,” Dr. Moon said.
Analysis of the more than 1,500 cases of lab-confirmed COVID-19 among liver disease patients submitted to SECURE-Liver so far have yielded important insights.
“Our work has demonstrated that patients with advanced cirrhosis have higher mortality from COVID-19 compared to similar individuals without liver disease, “ Dr. Moon said. “In contrast, we found that liver transplant recipients do not have a higher risk of death from COVID-19 compared to those who have not received a transplant. In liver transplant, the recipient’s age and medical comorbidities, but not type of immunosuppression, were shown to be important predictors of death.”
Data from the registry also have demonstrated that patients with autoimmune hepatitis do not appear to be at increased risk of death compared to patients with other forms of liver disease or individuals without liver disease.
“All these findings have been incorporated into many of the guidelines, including those from the AASLD, and have really contributed to our understanding of COVID-19 in patients with liver disease and prior liver transplantation,” Dr. Moon noted.
Despite the development and distribution of COVID-19 vaccinations, Dr. Moon expects the direct effects of SARS-CoV-2 will be present for years to come. SECURE-Liver is prepared to meet future needs for relevant data.
“The registry is designed to be quite nimble and can be adjusted to capture data on emerging questions,” he said, pointing to the addition of questions on post-vaccination COVID-19 infections to the case report form. “We hope this will help us better understand the patterns of post-vaccine susceptibility and inform research on the need for vaccination booster doses for patients with liver disease and other immunosuppressed populations.”
The SECURE-Liver case report form is available in English, Spanish, and French, with additional translations available soon.
In addition to AASLD, the International Liver Cancer Association (ILCA) and Chinese Portal Hypertension Diagnosis and Monitoring Study Group (CHESS) are partnering organizations for the registry.