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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 an observational study in Spain involving 8 paediatric patients (under 16 years of age) who had received compassionate treatment with remdesivir for COVID-19 during March 2020, an 11-year-old girl was described, who developed renal impairment during treatment with voriconazole and amphotericin-B-liposomal.
The girl (patient 8 from Table 1 of the article), who had Anti MDA5-associated dermatomyositis and interstitial lung disease (ILD), was admitted to a hospital in Spain with multilobar pneumonia (P. jirovencii pneumonia), respiratory insufficiency, myocarditis, pneumothorax, pneumomediastinum, pneumo-retroperitoneum and haemophagocytic histiolymphocytosis (HLH). She was eventually diagnosed with COVID-19. She had been treated with cyclophosphamide, tacrolimus, tofacitinib, cotrimoxazole and unspecified corticosteroids prior to diagnosis of COVID-19. She had been receiving amphotericin-B-liposomal [liposomal amphotericin B] and voriconazole [dosages, routes and indications not stated]. Thereafter, she started receiving off-label treatment with hydroxychloroquine, azithromycin, tocilizumab and unspecified corticosteroids for the COVID-19. She also underwent plasmapheresis. However, her respiratory status worsened, and she required ICU admission and invasive mechanical ventilation. Then, off-label treatment with remdesivir was initiated in March 2020 for the COVID-19. The PCR test resulted negative for COVID-19, 5 days after starting remdesivir. However, she developed sepsis, thrombotic, microangiopathy, coagulopathy, multiorgan failure as clinical complications. Also, she exhibited renal impairment, which was thought to be due to the multiorgan failure and use of nephrotoxic drugs (i.e. voriconazole and amphotericin-B-liposomal) [durations of treatments to reaction onset not stated].
Eventually, the girl died due to COVID-19 and complications on day 10 after initiation of remdesivir [outcome of the reaction not stated].
Reference
- Mendez-Echevarria A, et al. Compassionate use of remdesivir in children with COVID-19. European Journal of Pediatrics 180: 1317-1322, No. 4, Apr 2021. Available from: URL: 10.1007/s00431-020-03876-1 [DOI] [PMC free article] [PubMed]