Remdesivir

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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

In a study involving patients admitted to a hospital in France between 24 January 2020 and 1 March 2020 for coronavirus disease-2019 (COVID-19) and treated with remdesivir, 4 men aged between 31−80 years old were described, out of which, two men developed elevated alanine aminotransferase (ALT) along with maculopapular rash and remaining two men developed acute kidney injury with renal failure following treatment with remdesivir on compassionate use (off-label) basis [not all durations of treatments to reactions onsets and outcomes stated].

A 31-year-old man (case 1), who had flu-like symptoms for 6 days, was diagnosed with COVID-19 on 24 January 2020. He was immediately hospitalised. On day 10, due to the worsening oxygen saturation and bilateral ground-glass and alveolar opacities, he was transferred to an ICU. On 29 January 2020, he was started on compassionate use of IV remdesivir infusion at a loading dose of 200mg, and then a maintenance daily dose of 100mg. On 2 February 2020, remdesivir was stopped due to elevated ALT and maculopapular rash. The viral load was undetectable on day 2 of remdesivir infusion. Subsequently, his liver and skin abnormalities improved within 3 days after discontinuing remdesivir treatment. On 12 February 2020, he was discharged.

An 80-year-old man (case 2), who had thyroid cancer, presented on 25 January 2020 with fever and diarrhoea for 4 days. Three days later, he was diagnosed with COVID-19. On 26 January 2020, due to acute respiratory failure with multiple organ failure, he was transferred to an ICU. Unspecified broad-spectrum antibiotic treatment was started and adapted for co-infection with a susceptible Acinetobacter baumannii and Aspergillus flavus confirmed by tracheal aspirate culture. On 29 January 2020, he was started on compassionate use of IV remdesivir infusion at a loading dose of 200mg, and then a maintenance daily dose of 100mg. On 31 January 2020, remdesivir was stopped due to development of acute kidney injury, which led to renal failure requiring renal replacement therapy. A CT scan showed bilateral alveolar condensations, pulmonary cysts and ground-glass opacities. On 5 February 2020, because of the persistence of viral detection and disease severity, remdesivir was re-initiated; however, multiple organ failure persisted without any other co-infection. He died on 14 February 2020 [exact cause of death not stated].

A 39-year-old man (case 3), with obesity and obstructive sleep apnoea syndrome, was diagnosed with severe COVID-19 and was admitted to an ICU on 26 February 2020. A chest X-ray showed basal interstitial syndrome and he developed acute respiratory failure. On 27 February 2020, he was started on compassionate use of IV remdesivir infusion at a loading dose of 200mg, and then a maintenance daily dose of 100mg. The viral load was undetectable on day 5 of remdesivir infusion. He was weaned off oxygen on day 13. Remdesivir was discontinued after eight administrations due to elevated ALT and maculopapular rash. These symptoms resolved 5 days after remdesivir discontinuation. On day 20, he was discharged.

A 70-year-old man (case 5), who had chronic obstructive pulmonary disease, was diagnosed with COVID-19 on 1 March 2020. He had been receiving unspecified NSAID's for renal lithiasis. On 2 March 2020, he was admitted to an ICU due to acute respiratory distress syndrome. On 4 March 2020, he was started on compassionate use of IV remdesivir infusion at a loading dose of 200mg, and then a maintenance daily dose of 100mg. On 6 March 2020, remdesivir was stopped due to development of acute kidney injury, which led to renal failure requiring renal replacement therapy. The viral load was undetectable on day 2 of remdesivir infusion, expect for in bronchoalveolar lavage. Antibiotic therapy with cefotaxime was initiated due to Haemophilus influenzae respiratory co-infection. Nevertheless, he developed multiple organ failure and refractory acute respiratory distress syndrome despite adapted mechanical ventilation and prone positioning. On 12 March 2020, he was started on off-label treatment with dexamethasone and lopinavir/ritonavir. He died on 24 March 2020 [exact cause of death not stated].