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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 study of 21 patients admitted to a COVID-19 ICU of the hospital in India between June 2020 and July 2020 described two women and three men, aged 44−66 years, who developed opportunistic infections during off-label treatment with methylprednisolone for COVID-19 [duration of treatment to reactions onsets not stated].
Five patients, who had a history of hypertension and diabetes mellitus, were admitted to the COVID-19 ICU of the hospital in India with severe COVID-19. All the patients started receiving off-label treatment with IV methylprednisolone pulse 500 mg/day for 3 days, followed by oral methylprednisolone 1 mg/kg once daily, then tapered by 10−20 mg/day and finishing with 10mg. Methylprednisolone was given as single dose in the morning. Additionally, all the patients received off-label treatment with heparin [unfractionated heparin], IV piperacillin/tazobactam and azithromycin for 7 days, vitamin C [ascorbic-acid], vitamin B complex and zinc for COVID-19. Additionally, the patients received remdesivir for 5 days. Subsequently, all the patients developed opportunistic infections secondary to methylprednisolone use. The patients received steroid therapy for 8−14 days and were in the ICU for 8−14 days.
All the patients were treated with an appropriate treatments and required intubation. However, all the patients eventually died [outcomes and cause of deaths not stated].
Reference
- Jain S, et al. A retrospective evaluation of combination therapy of methylprednisolone and remdesivir for severe covid-19 patients. Journal of Clinical and Diagnostic Research 15: UC01 - UC04, No. 7, Jul 2021. Available from: URL: 10.7860/JCDR/2021/48622.15124 [DOI]