NASH clinical trials during the SARS-CoV-2 pandemic

As the COVID-19 continues to pose extreme challenges to healthcare systems, it is becoming impossible to avoid the overlap between COVID-19 and NASH pandemics. Numerous trials are being conducted despite the crisis and the COVID-19 pandemic has disrupted many aspects of NASH clinical trials, such as patient recruitment, administration...
PUBLISHED IN: Hepatology 2020

Commentary

As the COVID-19 continues to pose extreme challenges to healthcare systems, it is becoming impossible to avoid the overlap between COVID-19 and NASH pandemics. Numerous trials are being conducted despite the crisis and the COVID-19 pandemic has disrupted many aspects of NASH clinical trials, such as patient recruitment, administration of the therapeutic agents safety monitoring to data integrity.

In their commentary, the authors stress that there are solid scientific and ethical reasons to continue ongoing NAFLD/ NASH trials, particularly in view of the fact that there are no Food and Drug Administration (FDA)–approved therapies for NASH. However, they point out that patients with NAFLD have higher risk of progressive COVID-19, requiring mitigation strategies. One of them is to consider testing for SARS‐CoV‐2 within 72 hours prior to bringing patients in for a liver biopsy.

Take home message: The rationale for the continuation of NASH clinical trials during the COVID-19 pandemic is strong. It is necessary to implement strategies to mitigate the effects of the pandemic on the continuity and veracity of the data being collected and continue trial programs. The therapeutic options that are being investigated have the potential to benefit millions of people with NASH and fibrosis long after the coronavirus pandemic has ended.

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Dr. G. Bozet, MD

Articles: 174

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