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IRCT20150724023315N2 IRCT 2021-07-18 Birjand University of Medical Sciences Evaluation of the effect of melatonin in the treatment of patients with COVID-19 Evaluation of the effect of melatonin on improving the symptoms of patients with COVID-19-double-blind randomized clinical trial 2021-07-23 anticipated 46 Complete https://irct.ir/trial/56143 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Patients will be randomly divided into two groups of intervention and control using a random number table. First, we create a variable from 1 to 46 in Excel software. Then we create another variable in another column and generate 23 random numbers one and 23 random numbers two with the randomization command. The numbers of one and two are intervention and placebo groups, respectively, Blinding description: All of the steps will be covered by the patient, physician and evaluators. Packaging of the drugs will be exactly identical in both arms of the study. Preparation, packaging, and labeling of the drugs will be performed by the third person under the supervision of the senior manager of the project. 3 COVID-19. Intervention 1: Intervention group: Six melatonin tablet 3 mg (Razak pharmaceutical company, Tehran, Iran) at night along with standard treatment for 14 days. Intervention 2: Control group: Six Melatonin placebo tablet 3 mg (Industrial Laboratory of Mashhad School of Pharmacy, Mashhad, Iran) at night along with standard treatment for 14 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is -

public Mahmoud Ganjifard

Vali-e-Asr Hospital, Ghaffari Street

Birjand Iran (Islamic Republic of) 9717964151 +98 56 3162 2001 ganjim@bums.ac.ir Birjand University of Medical Sciences scientific Mahmoud Ganjifard

Vali-e-Asr Hospital, Ghaffari Street

Birjand Iran (Islamic Republic of) 9717964151 +98 56 3162 2001 ganjim@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Age 18 to 75 years Diagnosis of COVID-19 in the last 24 hours One of the three following: respiratory rate more than 30 per minutes, o2 saturation less than or equal to 93% at room temperature, PaO2/FiO2 less than or equal to 300 Female patients should not be pregnant and should not become pregnant until 30 days after the end of the study 18 years 75 years Both Patients with shock or hemodynamic instability (increase or decrease in blood pressure and irregular heartbeat) GFR less than 30 ml/minute History of cirrhosis, hepatitis and severe liver diseases History of hypertension, depression (taking fluvoxamine and other potent CYP1A2 inhibitors) and epilepsy Patients with a history of allergic reaction or allergy to melatonin Patients receiving chemotherapy for cancer Severe diseases of the immune system Pregnant and lactating women Use of alcohol and benzodiazepines U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Six melatonin tablet 3 mg (Razak pharmaceutical company, Tehran, Iran) at night along with standard treatment for 14 days Control group: Six Melatonin placebo tablet 3 mg (Industrial Laboratory of Mashhad School of Pharmacy, Mashhad, Iran) at night along with standard treatment for 14 days One-month mortality. Timepoint: From baseline to end. Method of measurement: Questionnaire. Time of death of patients. Timepoint: From baseline to end. Method of measurement: Questionnaire. Duration of hospitalization in the ICU. Timepoint: During hospitalization. Method of measurement: Questionnaire. Clinical symptoms according to the seven-category ordinal scale. Timepoint: Baseline and then on days 7 and 15. Method of measurement: Questionnaire. Lymphocyte count. Timepoint: Baseline and then on days 7 and 15. Method of measurement: Laboratory test. PaO2/FiO2 ratio. Timepoint: Baseline and then on days 7 and 15. Method of measurement: Laboratory test. ESR and CRP levels. Timepoint: Baseline and then on days 7 and 15. Method of measurement: Laboratory test. AST, ALT and LDH levels. Timepoint: Baseline and then on days 7 and 15. Method of measurement: Laboratory test. Number of patients who need support through mechanical ventilation. Timepoint: From baseline to end. Method of measurement: Questionnaire. Discharge from the hospital. Timepoint: From baseline to end. Method of measurement: Questionnaire. Fever relief time in patients who had a fever above 37.5 at the time of admission. Timepoint: During hospitalization. Method of measurement: Questionnaire. Adverse effects. Timepoint: On the 15th day. Method of measurement: Common Terminology Criteria for Adverse Event (CTCAE) version 5.0. Birjand University of Medical Sciences Approved 2020-11-09 Ethics Committee of Birjand University of Medical Sciences Birjand University of Medical Sciences , Ghaffari Street Birjand South Khorasan Iran (Islamic Republic of)