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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 35-year-old man developed COVID-19 infection following treatment with prednisolone and ciclosporin and, Klebsiella pneumoniae septicaemia following treatment with ciclosporin for thymomatous myasthenia gravis (MG) [routes and durations of treatments to reactions onsets not stated; not all dosages stated].
The man, who had thymomatous MG (diagnosed in 2008), underwent thymectomy in 2011. Thereafter, he started receiving prednisolone and azathioprine. His MG remained stable between 2011 and 2014. However, at the end of 2015. he developed aplastic anaemia due to thymoma. Azathioprine was then discontinued and he was initiated on ciclosporin [cyclosporine A] 50mg q12 and prednisolone was continued. The blood counts and anaemia improved gradually. He achieved pharmacological remission of myasthenia gravis on ciclosporin and prednisolone. Eventually, he presented with high grade fever with chills and productive cough for 5 days and breathlessness for 2 days. Six months prior to the current presentation, the blood counts and haemoglobin were noted to be stable on ciclosporin and prednisolone. On investigation following the current admission, he was found to be afebrile and tachypnoeic. He then received oxygen. Arterial blood gases demonstrated hypoxaemic respiratory failure. High resolution CT (HRCT) scan of the thorax demonstrated multiple focal and confluent areas of ground glass opacities with areas of consolidation. The COVID-19 reporting and data system score was found to be 5 and CT scan severity score was identified to be 18/25. Due to hypoxia, he was then intubated and mechanical ventilation was started. Thereafter, blood investigation demonstrated thrombocytopenia and lymphopenia. Also IL-6, CRP and ferritin levels were increased and D-dimer was noted to be within normal range. RT‑PCR for SARS‑CoV‑2 of endobronchial washings was found to be positive. Thus, he was diagnosed with COVID-19 infection. The immunocompromised state due to immunosuppressive therapy with prednisolone and ciclosporin was found to be responsible for the development of COVID-19 infection.
Consequently, ciclosporin was discontinued. The man was then started on off label therapy with cefoperazone/sulbactam and clarithromycin for COVID-19 infection. Additionally, he received unspecified low molecular weight heparin and anti-inflammatory therapy with dexamethasone. Due to the worsening PaO2/ FiO2 ration, prone ventilation support was started. On hospital day 9 he developed melena and endo-tracheal bleeding secondary to aplastic anemia. Thus, unspecified low molecular heparin was terminated. Over the next 7 days, he received multiple platelet transfusions. He had new-onset high grade fever on hospital day 11. Also, BP decreased and fluctuations in PaO2/FiO2 ratios was observed. Thereafter, the blood and endobronchial secretion cultures identified extensively drug resistant Klebsiella pneumoniae. He was then diagnosed to have Klebsiella pneumoniae septicaemia and the development of gram negative septicaemia was attributed to ciclosporin.
He was then started on unspecified inotropes and polymyxin B. Due to the difficulty of weaning from the ventilation, he had undergone percutaneous tracheostomy on hospital day 15. Eventually, his clinical condition improved and he was weaned off from ventilation and de-cannulated on day 25. During the entire course of hospitalisation, no new‑onset weakness was noted. Thus, myasthenia gravis was considered to be remained in remission. The development of hypoxaemic respiratory failure was then attributed to COVID-19 infection. At the time of discharge, electrodiagnostic test demonstrated normal motor and sensory nerve conduction. Normal motor and sensory function was noted on repetitive nerve stimulation studies. He was then discharged in a stable condition with advice of respiratory exercises and supportive medication. During a follow-up after 1 month of discharge, he was found to be stable and was free from any myasthenic symptoms. Therefore, he was restarted on ciclosporin for aplastic anaemia.