Investigating the Effectiveness of Melatonin in the Treatment of Critically Ill Patients with COVID-19 Hospitalized in the Intensive Care Unit: A Double-Blind Randomized Clinical Trial.

Background: Melatonin, a tryptophan product, has anti-inflammatory and virucidal effects. A study evaluated whether melatonin is more effective than placebo in critically ill COVID-19 patients.

Methods: The present study used a double-blind, randomized clinical trial in patients with COVID-19 hospitalized in the intensive care unit of Rasool Akram Hospital, Tehran. Iran. Melatonin 10 mg and placebo were given to the patients at night before bed. Patients were randomly divided into 2 groups. The first group was given melatonin with a therapeutic dose of 10 mg daily, and the second group was given a placebo with the same dose of 10 mg daily. Patients received melatonin or placebo for 7 days.The chi-square or Fisher exact test was used to compare qualitative variables. The study analyzed the mean of the variables under investigation by conducting a 2-factor repeated measures analysis of variance at 3 different time intervals in those administered medication or placebo.

Results: The study analyzed 44 melatonin patients and 42 placebo groups. The mean intensive care unit (ICU) hospitalization days were 11.23 ± 4.73 days in the melatonin group and 11.90 ± 6.52 days in the placebo group (P = 0.582). The mean days of hospitalization in the melatonin group were 19.70 ± 8.77 days and 21.48 ± 10.85 days in the placebo group (P = 0.407). The mean oxygen saturation before and after discharge from ICU in the melatonin group was 81 ± 6.73%, 91.02 ± 1.17%, and in the placebo group, 83.36 ± 8.27%, 91.21 ± 1.26, respectively (P = 0.467 and P = 0.150).

Conclusion: Melatonin can significantly reduce inflammation and oxidative stress markers in patients, making it a promising therapeutic option for COVID-19 patients. Further research is needed to determine the optimal treatment dosage and duration. Nonetheless, these results offer a promising avenue for future research and clinical practice.