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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 74-year-old man exhibited lack of efficacy with off-label use of dexamethasone in SARS-CoV-2 infection [route and dosage not stated].
The man presented with renal insufficiency post SARS-CoV-2 infection. He was diagnosed with SARS-CoV-2 infection in 2020. His vaccination history was negative for SARS-CoV-2. He developed severe pneumonia, while on off label treatment with dexamethasone (lack of efficacy), and was managed with extracorporeal membrane oxygenation and artificial respiration. He was hospitalised for 5 months. Prior to SARS-CoV-2 infection, he was never suspected to have nephritis. During the treatment of SARS-CoV-2 infection, his renal function altered and abnormalities were noted in urinalysis. Therefore, he was referred after 1 month from his discharge. On admission, apart from pitting oedema in his leg, he had no other abnormalities. Laboratory investigations revealed the following: creatinine 3.09 mg/dL, IgA 461 mg/dl, proteinase-3 antineutrophil cytoplasmic antibodies (ANCA) <0.5 IU/mL, serum anti-glomerular basement membrane antibody <0.2 IU/mL. Urinalysis revealed proteinuria and microscopic haematuria. Kidney biopsy showed moderate mesangial cell proliferation and cellular crescents in 4 of 20 glomeruli. The MEST-C classification of the kidney biopsy was M1E1S1T1C2. Immunofluorescence test revealed deposition of IgA and C3 in the mesangial regions. Based on the investigations, a diagnosis of IgA nephropathy was considered. He underwent tonsillectomy and steroid pulse therapy. After 35 days of treatment, his creatinine levels and proteinuria improved.
Reference
- Yonishi H, et al. New-onset immunoglobulin-A nephropathy post severe acute respiratory syndrome-coronavirus-2 infection indicates rapidly progressive glomerulonephritis. Nephrology 27: 542-543, No. 6, Jun 2022. Available from: URL: 10.1111/nep.14003 [DOI] [PMC free article] [PubMed]