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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 retrospective analysis of the prospectively collected data involving 81 patients with SARS-CoV-2 infection treated between 26 March 2020 and 28 May 2020 in Spain, a patient [age and sex not stated] was described, who developed QTc prolongation during an off-label treatment with hydroxychloroquine for SARS-CoV-2 infection [route, dosage and duration of treatment to reaction onset not stated]. The mean basal QTc was found to be 416ms while the mean longest QTc was found to be 459ms. Also, the mean of QTc prolongation was of 43ms. The QTc prolongation resolved eventually after following unspecified protocol steps.
Reference
- Gonzalez NT, et al. QT interval measurement with portable device during COVID-19 outbreak. IJC Heart and Vasculature 30: Oct 2020. Available from: URL: 10.1016/j.ijcha.2020.100644 [DOI] [PMC free article] [PubMed]