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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 severe acute kidney injury and severe acute haemolytic anaemia during off-label treatment with hydroxychloroquine for COVID-19 pneumonia. Additionally, he received off-label treatment with azithromycin for COVID-19 pnuemonia.
The man, who had been receiving gliclazide for type 2 diabetes mellitus and lercanidipine for arterial hypertension, presented to hospital with fatigue. On admission, he was diagnosed with COVID-19 pnuemonia. He received off-label treatment with hydroxychloroquine and azithromycin, including a loading dose of hydroxychloroquine [routes and dosages not stated]. On day 7, he developed severe acute kidney injury and severe acute haemolytic anaemia (blood test results were consistent with severe acute kidney injury and severe acute haemolytic anaemia). He was also diagnosed with an underlying severe glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Due to the ongoing oliguria, the man was initiated on haemodialysis. After 23 days, his kidney function recovered and dialysis was therefore stopped. On day 72, there was improvement in the haemolytic anaemia; however, a slight impairment of kidney function was observed on day 72 as per the blood tests, indicating an incomplete renal recovery.
Reference
- Semeu PNK, et al. Aki following hemolysis related to hydroxychloroquine treatment for COVID-19 in a G6PD-deficient patient. Journal of the American Society of Nephrology 31: 812 abstr. PUB070, Jan 2020. Available from: URL: https://www.asn-online.org/education/kidneyweek/archives/ [abstract]