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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 68-year-old man developed Cytomegalovirus (CMV) enterocolitis and hypovolaemic-shock following off-label treatment with hydroxychloroquine and tocilizumab for COVID-19 pneumonia [routes, dosages and durations of treatments to reaction onsets not stated].
The man, who had a history of hypertension and glaucoma, presented with 1 week history of nausea, emesis and fever. He became hypoxic and required supplemental oxygen. After initial examinations, atypical pneumonia was suspected, and his treatment was started with cefepime, vancomycin and azithromycin. Tests led to the identification of Streptococcus and Staphylococcus species. He then developed acute respiratory distress syndrome, requiring ICU admission with intubation, mechanical ventilation and extracorporeal membrane oxygenation. Samples were collected for COVID-19 examination prior to ICU transfer. While awaiting the confirmation of COVID-19, he received five doses of off-label hydroxychloroquine as per experimental protocol. The tests for COVID-19 returned positive on day 6 of hospitalisation. On day 7 of admission, he received a single dose of tocilizumab (off-label therapy). Additionally, he received a 10 day course of remdesivir. However, during the ICU stay, he developed high output diarrhoea with hypovolemic shock.
Therefore, gastroenterology was consulted, and octreotide, colestyramine [cholestyramine], diphenoxylate/atropine and unspecified probiotics were added to the man's treatment regimen, but significant improvement was not observed. A CT-scan of the abdomen and pelvis demonstrated extensive bowel wall thickening of the colon and distal ileum with rectal sparing. Tests for infectious aetiologies including CMV showed negative results. After 2 weeks, as he continued to have high output stools, repeat tests showed highly elevated CMV viral load (55937 IU/mL) indicating viraemia. Further tests showed elevated CMV-IgG. Therefore, his treatment was started with ganciclovir. Colonoscopy yielded multiple raised plaques within the terminal ileum and pan-colonic ulcerations which were biopsied and clipped. The biopsy of these tissues demonstrated focal glandular atypia, pseudostratification of enlarged nuclei, and inclusion bodies with positive immunohistochemical staining for CMV.
Reference
- Geisen WR, et al. Cytomegalovirus Enterocolitis secondary to experimental COVID-19 therapy. IDCases 22: 2020. Available from: URL: 10.1016/j.idcr.2020.e00962 [DOI] [PMC free article] [PubMed]