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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
* Drug interaction
In a study consisting of 50 patients who were treated with hydroxychloroquine and azithromycin from 18th March 2020 to 25th March 2020, one patient [age and sex not stated] was described, who developed acute QT interval prolongation following concomitant administration of hydroxychloroquine and azithromycin as off-label therapy for COVID-19.
The patient was hospitalised with COVID-19 pneumonia. The patient started receiving off-label treatment with hydroxychloroquine and azithromycin. Hydroxychloroquine was scheduled to be administered at a dose of 600 mg/d for 10 days and azithromycin was scheduled to be administered at a dose of 500 mg/d on day 1 and 250 mg/d from day 2 to day 5 [routes not stated]. Subsequently, a 12-lead ECG showed QT interval prolongation. The acute QT interval prolongation was considered to have developed secondary to drug interaction between hydroxychloroquine and azithromycin [time to reaction onset not stated].
Therefore, the patient discontinued hydroxychloroquine and azithromycin. On day 2 after discontinuation of hydroxychloroquine and azithromycin, the patient's QT interval was found to be stable at 500ms. Thereafter, the patient was discharged.
Reference
- Voisin O, et al. Acute QT Interval Modifications During Hydroxychloroquine-Azithromycin Treatment in the Context of COVID-19 Infection. Mayo Clinic Proceedings 95: 1696-1700, No. 8, Aug 2020. Available from: URL: 10.1016/j.mayocp.2020.05.005 [DOI] [PMC free article] [PubMed]