High dose melatonin as an adjuvant therapy in intubated patients with COVID-19: A randomized clinical trial

OBJECTIVE: In the COVID-19 pandemic, the SARS-CoV-2 virus has infected millions of people worldwide. Mortality primarily results from the inflammation state and its complications. High-dose melatonin has been established as an anti-inflammatory agent. This study evaluated high-dose melatonin as an adjuvant therapy in critically ill patients with SARS-CoV-2 infection. METHODS: We conducted a double-blinded, randomized clinical trial of 21 mg of melatonin per day compared with a placebo in 67 patients with COVID-19. We enrolled patients older than 18 years of age with documented SARS-CoV-2 infection, who were admitted to the intensive care unit and underwent invasive mechanical ventilation. Administration of melatonin and placebo through a nasogastric tube continued for 5 days. The main outcomes were mortality rate, duration of mechanical ventilation, changes in oxygenation indices, and C-reactive protein (CRP) levels. RESULTS: No significant differences were observed in mortality and duration of mechanical ventilation between the control and intervention groups. After 5 days of the intervention, the mean (±standard deviation) CRP and platelet count were 47.28 (±38.86) mg/L and 195.73 (±87.13) × 1000/μL, respectively, in the intervention group and 75.52 (±48.02) mg/L and 149.62 (±68.03) × 1000/μL, respectively, in the control group (P < 0.05). CONCLUSION: High-dose melatonin in intubated patients with COVID-19 was associated with a decrease in CRP levels. However, this treatment did not apparently affect patient outcomes.