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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 23-year-old woman developed cardiac toxicity during off-label treatment with chloroquine for coronavirus disease-2019 (COVID-19) infection.
The woman, who had a fever, fatigue, dry cough and dyspnoea, was admitted to the intensive care unit. Subsequent reverse transcriptase-polymerase chain reaction (RT‐PCR) test on a nasopharyngeal swab specimen was positive for SARS‐CoV‐2 ARN. Thereafter, a chest computed tomography scan was performed which showed bilateral pulmonary infiltrates. Subsequently, she started receiving off-label treatment with chloroquine [route and dosage not stated] for COVID-19 infection. However, following the single dose of chloroquine, she developed cardiac toxicity.
The woman's chloroquine was discontinued [outcome not stated]. Then, based on the further laboratory test, she was diagnosed with systemic lupus erythematosus (SLE) with antiphospholipid antibody syndrome (APS). Consequently, she started receiving steroid therapy with methylprednisolone. Her COVID-19 infection deteriorated to hypoxaemic respiratory failure. Hence, invasive mechanical ventilation was initiated. After 13 days from COVID-19 diagnosis, she developed a skin rash on the trunk. Dermatologic examination revealed erythematous papules and papulovesicles scattered bilaterally and symmetrically on the trunk. Histopathological examination showed orthokeratotic hyperkeratosis with a perivascular inflammatory infiltrate. Her COVID-19 infection deteriorated. She died 16 days after the diagnosis of COVID‐19.
Slimani Y, et al. Systemic lupus erythematosus and varicella-like rash following COVID-19 in a previously healthy patient. Journal of Medical Virology 93: 1184-1187, No. 2, Feb 2021. Available from: URL: http://doi.org/10.1002/jmv.26513