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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 multicenter, observational, retrospective cohort study conducted in the USA involving 18 patients with a diagnosis of COVID-19 and concurrent kidney disorders between 7 May 2020 and 15 July 2020, 7 patients [ages and sexes not stated] were described, who developed ALT abnormalities, worsening creatinine, hyperglycaemia, anaemia, burning at infusion site or worsening kidney function during treatment with remdesivir for COVID-19 [not all routes and duration of treatments to reactions onset stated; outcomes not stated].
The patients were hospitalised with a confirmed diagnosis of COVID-19. All patients had concurrent kidney disorders with an estimated glomerular filtration rate of <30 mL/min/1.73m2. On admission, all patients started receiving remdesivir 200mg as IV bolus on day 1 of treatment followed by 100 mg/day. However, the patients developed adverse events attributed to remdesivir. These included grade 2 hyperglycaemia (2 patients) each on day 4 of the treatment, grade 3 anaemia on day 3 of the treatment (1 patient), burning at the IV infusion site on the last fifth dose (1 patient), grade 2 ALT abnormalities (1 patient) and worsening kidney function (1 patient). One remaining patient developed worsening creatinine that was likely attributed to remdesivir per study investigators.
Two patients discontinued remdesivir early due to worsening kidney function (1 patient) and burning at the IV infusion site (1 patient).
Reference
- Estiverne C, et al. Remdesivir in Patients With Estimated GFR <30 ml/min per 1.73 m2 or on Renal Replacement Therapy. Kidney International Reports 6: 835-838, No. 3, Mar 2021. Available from: URL: 10.1016/j.ekir.2020.11.025 [DOI] [PMC free article] [PubMed]