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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
In a single centre, retrospective observational study of 90 patients hospitalised at an institute in USA between 1 March 2020 and 7 April 2020, two patients [ages and sexes not stated] were described, who developed prolongation of QTc interval, torsade de pointes, cardiomyopathy, ventricular arrhythmias, bradycardia or hypoglycaemia during off-label treatment with hydroxychloroquine (1 patient) or during treatment with propofol and off-label treatment with hydroxychloroquine and azithromycin for pneumonia associated with corona virus infection (Covid-19) [not all indications and dosages stated; routes and outcomes not stated].
Case 1: The patient, who tested positive for Covid-19 associated pneumonia, was hospitalised at an institute in USA and was prescribed off-label treatment with hydroxychloroquine 400mg twice a day on day 1 followed by 400mg daily from day 2. However, on day 2 of the treatment, the patient developed hypoglycaemia, which was attributed to poor oral intake and hydroxychloroquine therapy.
Case 2: The patient, who tested positive for Covid-19 associated pneumonia, was hospitalised at an institute in USA and received off-label treatment with hydroxychloroquine 400mg twice a day on day 1, followed by 400mg daily from days 2 along with azithromycin. Subsequently, the patient developed prolongation of QTc interval (499 millisecond). Therefore, azithromycin and hydroxychloroquine were stopped. However, 3 days later, the patient developed torsades de pointes, further complicated by other ventricular arrhythmias. During investigations, it was found that the patient also received propofol concomitantly. The patient developed bradycardia and cardiomyopathy that was suggestive of persisting prolonged QTc interval. The patient was treated with lidocaine. The patient also developed severe acute respiratory distress syndrome and hypothermia secondary to Covid-19.
Reference
- Mercuro NJ, et al. Risk of QT Interval Prolongation Associated With Use of Hydroxychloroquine With or Without Concomitant Azithromycin Among Hospitalized Patients Testing Positive for Coronavirus Disease 2019 (COVID-19) JAMA Cardiology : 2020. Available from: URL: http://dx.doi.org/10.1001/jamacardio.2020.1834 [DOI] [PMC free article] [PubMed]