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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 case series, a 73-year-old woman developed diarrhoea, liver damage and loss of appetite during off-label treatment with lopinavir/ritonavir for SARS-CoV-2.
The woman embarked on the Diamond Princess on 20 January 2020 and landed in Hong Kong on 25 January 2020. On 4 February 2020, she developed sore throat, malaise and loss of appetite. She developed fever on 7 February 2020. On 10 February 2020, a throat swab PCR test was found to be positive for SARS-CoV-2. On 11 February 2020, she was admitted to hospital. She was started with O2 1 L/min nasal to maintain oxygen saturation at 95%. She developed fatigue, could hardly take any food and lying down almost all the time. Communication was poor. She started receiving fluid resuscitation and off-label azithromycin and ceftriaxone. However, her oxygenation worsened gradually. On 14 February 2020, O2 was increased to 4 L/min, and 4 tablets of off-label lopinavir/ritonavir 800/200mg [route not stated] were started. Consequently, her fever and oxygenation improved. However, she developed lopinavir/ritonavir related diarrhoea, liver damage and loss of appetite.
Therefore, on 19 February 2020, lopinavir/ritonavir was discontinued. On the following day, the woman was started on off-label ciclesonide inhalation 200µg twice daily [Alvesco]. Within 2 days, her fever, oxygenation and hypoxaemia improved. On 22 February 2020, she had voluntary food intake of about 1200kcal. Her fatigue improved. She was able to walk. Her appetite remarkably recovered. Two nasal swab PCR tests on 25 and 26 February 2020 were found to be negative for SARS-CoV-2. On 28 February 2020, she was discharged. Currently, ciclesonide inhalation of 400µg twice daily was being continued until the end of the kit, and outpatient follow-up was planned [outcomes not stated].
Reference
- Iwabuchi K, et al. Therapeutic potential of ciclesonide inahalation for COVID-19 pneumonia: Report of three cases. Journal of Infection and Chemotherapy 26: 625-632, No. 6, Jun 2020. Available from: URL: 10.1016/j.jiac.2020.04.007 [DOI] [PMC free article] [PubMed]