Methylprednisolone

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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 55-year-old woman experienced decrease in the T cell count during off label treatment with methylprednisolone for COVID-19.

The woman, who had a history of type 2 diabetes mellitus, developed paroxysmal dry cough with fever and diagnosed with upper respiratory tract infection. Hence, treated with cefotaxime. However, she had no significant improvement. Subsequently, she was admitted to the ICU due to severe viral pneumonia on 19 January 2020. She was treated with oseltamivir and piperacillin/tazobactam and high-flow oxygen therapy. Her respiratory tract sample was sent for testing. Thereafter, tracheal intubation and mechanical ventilation was provided. After the intubation, she started receiving off label treatment with IV methylprednisolone 40 mg/12 hour on 19 January 2020. Additionally, antibacterial therapy with piperacillin/tazobactam, antiviral therapy with oseltamivir and immunodulator therapy with immune globulin [Human immunoglobulin] and norepinephrine [norepinephrine hydrochloride] for maintenance of BP was initiated. Pulmonary protective ventilation, restrictive fluid infusion and other symptomatic treatments were started. Her inflammatory cytokines such as T cell subsets, IL-6 and IL-10 in peripheral blood were monitored. The number of CD3⁺ T, CD4⁺ T and CD8⁺ T cells were significantly lower than the normal value, which gradually increased and then decreased with administration of methylprednisolone [duration treatment to reaction onset not stated]. On hospitalisation day 4, she was diagnosed with COVID-19, critical respiratory distress syndrome, type 2 diabetes mellitus and septic shock.

On the same day, the woman's dose of methylprednisolone was decreased to 40 mg/day due to decrease in the T cell count. On hospitalisation day 7 and 8, she received methylprednisolone 40mg. Thereafter, dose of methylprednisolone gradually reduced and discontinued. She received the total 480mg of methylprednisolone. She also received off label treatment with lopinavir/ritonavir, interferon-α for COVID-19. Additionally, she was treated with cefoperazone/sulbactam as antibacterial drug therapy and thymosin α as immunomodulators. On hospitalisation day 16, she was extubated and T cell count had normalised with negative results for COVID-19.