Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in Hospitalized Patients with COVID-19: A Randomized, Double-blind Clinical Trial.
Level 2 - randomized trial
Single-center randomized, double-blind controlled clinical trial.
PubMed 34229896 · doi:10.1016/j.arcmed.2021.06.006
What was done
In a single-center, double-blind randomized clinical trial in Tehran, Iran, 74 hospitalized patients with confirmed mild-to-moderate COVID-19 were randomized 1:1 to standard of care alone or standard of care plus melatonin (3 mg three times daily) for 14 days. Clinical symptoms, C-reactive protein (CRP), and radiological pulmonary involvement were evaluated baseline to post-intervention, with safety and clinical outcomes tracked for 4 weeks.
What was found
Only 44 patients completed treatment (24 in the melatonin group, 20 in the control group). The melatonin group showed statistically significant improvements compared with controls in cough, dyspnea, fatigue, CRP levels, and pulmonary involvement (all p < 0.05; exact figures not reported in the abstract). Mean time to hospital discharge and return to baseline health were significantly shorter in the melatonin group (p < 0.05). Zero deaths and zero adverse events occurred in either arm.
Why it matters
This study provides randomized trial evidence that low-dose adjuvant melatonin may accelerate recovery and shorten hospital stays for mild-to-moderate COVID-19 at low cost.
Limits
The abstract omits exact point estimates, effect sizes, and confidence intervals for all outcomes. The sample size is small, conducted at a single hospital, and experienced high post-randomization dropout (30 of 74 enrolled did not complete treatment), raising potential attrition bias. Findings cannot be generalized to severe or critical COVID-19.
Cited by
- supports Melatonin administered as an adjunct therapy during COVID-19 infection improved clinical recovery outcomes.