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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 65-year-old man developed aggravation of liver toxicity leading to liver failure during treatment with ramipril for hypertension.
The man, who presented with cough, dyspnoea and fever was diagnosed with SARS-CoV-2 infection. Laboratory tests showed elevated levels of aminotransferases including AST and ALT. During investigations, it was found that he had arterial hypertension, for which, he had been receiving long term treatment with ramipril [route and dosage not stated] and hydrochlorothiazide. He did not have any prior history of liver disease. Simultaneously, following hospital admission, he was treated with off-label piperacillin/tazobactam and azithromycin with paracetamol. However, he developed progressive respiratory failure and he was maintained on mechanical ventilation. Thereafter, he was treated with off-label ritonavir and lopinavir in combination with interferon-beta from day 3-10 and 13 respectively, but due to no significant effect and progression of liver dysfunction, this treatment was stopped. His total bilirubin levels increased to a maximum of 22.2 mg/dL. After a few days, his renal function also deteriorated and he required continuous renal replacement therapy. Additionally, he developed multi-organ failure secondary to liver and kidney failure. As per the model for end stage liver disease, his score was 40. At day 20, he remained in a clinically critical situation. It was suspected that his treatment with ramipril aggravated liver toxicity secondary to SARS-CoV-2 infection.