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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 45-year old man did not respond to off-label treatment with eculizumab for COVID-19 infection.
The man presented to hospital in France with dry cough, diarrhoea and myalgia for 3 days. He also reported anosmia. His medical history was notable for multiple morbidities, including paroxysmal nocturnal haemoglobinuria (PNH) since the age of 18 years, for which he had been receiving IV eculizumab 1200mg every 12 days, since 2008. Three days prior to his current presentation, he had received an infusion of eculizumab. A few hours later, fever and myalgia developed.
The man was initially treated with empirical therapy comprising amoxicillin/clavulanate and ciprofloxacin, without improvement. Thereafter, he was hospitalised. Subsequent analyses following his current presentation led to the diagnosis of Covid-19. Therefore, his ongoing antibiotic medications were discontinued, and he started receiving off-label hydroxychloroquine 200mg three times a day. Seven days following initial onset of symptoms, he developed a severe hypoxaemic syndrome, which necessitated oxygen supplementation. He subsequently started receiving off-label lopinavir/ritonavir, alongside venous thromboembolism prophylaxis with enoxaparin sodium [enoxaparin]. He continued receiving eculizumab at the same dose, on days 7, 19 and 29 of hospitalisation. However, in spite of treatment with eculizumab, the course of the infection continued to aggravate, indicating a lack of efficacy. Following further deterioration of laboratory parameters, hydroxychloroquine and lopinavir/ritonavir were discontinued, and he started receiving off-label IV tocilizumab 8mg per kg. He was shifted to the ICU, where he received a second line of antibiotics, comprising azithromycin and cefotaxime. Two days later, he developed acute respiratory distress syndrome, which necessitated lung-protective mechanical ventilation with neuromuscular blockade. After three sessions of prone positioning, his respiratory parameters gradually improved, and his fever subsided. After 25 days of mechanical ventilation, he underwent percutaneous tracheostomy to facilitate weaning. He finally tested negative for SARS-CoV-2 on day 31, after which he was discharged from the ICU. Follow-up imaging confirmed disappearance of the Covid-19-related findings.