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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 9-week-old girl exhibited lack of efficacy during treatment with remdesivir for SARS-CoV-2 infection.
The girl, who had a history of cardiopulmonary failure secondary to unrepaired congenital heart disease, presented to hospital with acute hypoxaemic respiratory failure secondary to progressive decompensated heart failure. Chest X-ray revealed pulmonary oedema and cardiomegaly. She started receiving milrinone and unspecified diuretics, which resulted in restoration of organ function. By hospital day 8, her treatment was switched from milrinone to captopril and carvedilol, and her diuretics were continued. On day 12 of hospitalisation, she developed acute hypoxaemic respiratory failure, decompensated heart failure and atelectasis, which required ventilation. She was tested positive for SARS-CoV-2 infection. She started receiving remdesivir 5 mg/kg/day from day 15 [route not stated]. The remdesivir dose was later changed to 2.5 mg/kg/day from day 16-25. However, she developed staphylococcal scalded skin syndrome and received a treatment with nafcillin. She also developed stage II necrotizing enterocolitis, which was treated with piperacillin-tazobactam. Laboratory investigations revealed elevated C-reactive protein and persistent lymphopenia.
On day 25, despite completion of the treatment with remdesivir, the girl required endotracheal intubation for worsening respiratory failure. Laboratory investigations revealed elevated C-reactive protein and persistent lymphopenia. Milrinone was restarted along with diuretics. Due to her lack of response to remdesivir and worsening clinical condition, she started receiving convalescent plasma from COVID-19 recovered donors. Subsequently, ventilator support was reduced and she was extubated on day 34. SARS-CoV-2 infection completely resolved by day 91.
Reference
- Rodriguez Z, et al. COVID-19 convalescent plasma clears SARS-CoV-2 refractory to remdesivir in an infant with congenital heart disease. Blood Advances 4: 4278-4281, No. 18, 22 Sep 2020. Available from: URL: 10.1182/bloodadvances.2020002507 [DOI] [PMC free article] [PubMed]