Evaluating the effect of Melatonin in prognosis and clinical improvement in patients with COVID-19: A Randomized Clinical Trial

Determining the effect of melatonin on clinical improvement and prognosis of patients with Covid-19

The randomized double-blind clinical trial, with parallel design in phase 3, conducted on 60 patients

This study is a randomized, double-blind clinical trial that will be performed on adult patients (aged 18 to 75 years) with a definitive diagnosis of COVID-19 referred to the specialized clinic of Shahid Beheshti Hospital. In this study, 60 patients who according to the guidelines of the World Health Organization (WHO) and the latest flowchart of diagnosis and treatment of Covid 19 disease in the outpatient and inpatient services of the Ministry of Health and Medical Education (March 4, 2020) diagnosed as a definitive COVID-19and according to the physician and the clinical signs and symptoms of mild to moderate disease without pulmonary involvement and no signs of respiratory distress in them will be included in the study. The therapist and the patient are unaware of the allocation of the treatment regimen and the study is double-blind

Patients aged 18 to 75 years with a definitive diagnosis of Covid-19 who are hospitalized in the ward are included in the study. Patients with intolerance to melatonin or taking immunosuppressive drugs in the last three months have been excluded from the study .

The intervention group will receive melatonin supplement at a dose of 18 mg twice a day for 7 days and orally with standard treatment. And the control group will receive standard treatment.

The need for oxygen therapy, death rate, side effects, the amount of hospitalization in the intensive care unit for 28 days and, if necessary, the number of days of hospitalization in the intensive care unit in two investigated groups.

For randomization, we will use the method of Balanced Block Randomization (block size: 4). For this purpose, we prepare four sheets of paper. On the two sheets, we write the I meaning "Intervention" and on the other two sheets we write the P meaning "Placebo". Mix the sheets together and place them in the desk drawer. When referring to any of the eligible patients, one of the sheets was randomly taken out, and based on this sheet, I or P was assigned to one of the two groups of intervention (melatonin recipient) or comparison (placebo recipient). They will be. Extracted tabs will not be returned to the drawer until all four tabs have been extracted. After randomly pulling out all four sheets, all the sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size (60 patients) is reached.

Both the intervention and control groups will receive drugs with the same appearance, the intervention group will receive melatonin in addition to the standard drugs, and the control group will receive standard drugs and placcebo. The drugs for each group are specified with a special code and the patient and the treating physician will be unaware of the type of drug used by the patients. Therefore, the study will be conducted in a double-blind manner.