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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 68-year-old man developed a worsening of haemolytic crisis during off-label treatment with hydroxychloroquine for Coronavirus disease (COVID-19).
The man presented to the hospital with muscular pain, fever, dyspnoea and tiredness, and was subsequently admitted to a hospital in Switzerland due to positive COVID-19 infection. His medical history was significant for stroke, high blood pressure, type 2 diabetes mellitus and chronic renal insufficiency (G2 stage). On day 1, according to the institutional protocol, he was started on off-label treatment with amoxicillin/clavulanic-acid [amoxicillin/clavulanate] 1.2g 4 times daily and admitted in the general internal medicine division. In view of the development of acute respiratory distress syndrome and rapid respiratory degradation on day 3, his amoxicillin/clavulanic-acid treatment was switched to piperacillin/tazobactam. Later, he was transferred to the ICU and required mechanical ventilation. On day 6, according to the institutional protocol, he was started on off-label treatment with a single dose of hydroxychloroquine 600mg [route not stated]. However, during admission, he developed a significant drop in haemoglobin from 12 g/dL to 6.5 g/dL on day 1 and day 6, respectively.
The man was treated with several blood transfusions. Further investigations excluded digestive spoliation. Blood workup showed a marked elevation in total and direct bilirubin and lactate dehydrogenase levels from day 5 along with biological signs of haemolysis. Numerous hemi-ghost cells and microspherocytes were observed in peripheral blood smear analysis, which indicated an acute haemolytic crisis in the context of an unknown glucose-6-phosphate dehydrogenase (G6PD) deficiency [duration of treatment to reaction onset not stated]. Further review of the daily blood smears analysis report suggested an appearance of hemi-ghost cells and microspherocytes started from day 4 and slowly increased until day 7. Further investigation also confirmed a diagnosis of G6PD. However, it was also noted that the worsening of haemolytic crisis occurred on the next day of administration of hydroxychloroquine. Also, he did not take any medication, which could precipitated haemolysis. Based on the presenting symptoms and these findings, it was concluded that his severe COVID-19 infection triggered a haemolysis crisis with G6PD deficiency, which was possibly worsened by hydroxychloroquine therapy [outcome not stated].
Reference
- Beauverd Y, et al. COVID-19 infection and treatment with hydroxychloroquine cause severe haemolysis crisis in a patient with glucose-6-phosphate dehydrogenase deficiency. European Journal of Haematology 105: 357-359, No. 3, Sep 2020. Available from: URL: 10.1111/ejh.13432 [DOI] [PMC free article] [PubMed]