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IRCT20210505051197N1 IRCT 2021-07-18 Rasht University of Medical Sciences Melatonin and Covid-19 Study of therapeutic effect of melatonin in patients with COVID-19 : a double-blind randomized clinical trial 2021-07-24 anticipated 96 Complete https://irct.ir/trial/56205 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method will be used for random assignment to intervention and control groups (each block includes 6 patients). assigned sequences and hidden codes are generated using www.sealedenvelope.com.The closed envelope method will be used to hide the sequence, Blinding description: ٍParticipants , clinician, researcher, outcome assessor, data analyst except clinical pharmacist (responsible for randomization) don't know which arm the participant is assigned to and will be blind to the allocation of melatonin and placebo. Placebo tablets will be similar in shape,size and color to melatonin. At the beginning of the study the safety monitoring committee and data on the allocation of melatonin and placebo will be blind .In case of any serious complications in the participants or significant differences in the study groups, the code of the participants or study groups will be decoded at the request of the above committee.Hidden codes are generated using www.sealedenvelope.com. The closed envelope method will be used to hide the assigned sequence. 2-3 covid-19. Intervention 1: Intervention group1: 6 mg Melatonin (2 tablets of 3 mg melatonin made by Simorgh Pharmaceutical Company) is given orally every night for 5 nights. Intervention 2: Intervention group2: 12 mg of melatonin (4 tablets of 3 mg melatonin made by Simorgh Pharmaceutical Company) is given orally every night for 5 nights. Intervention 3: Control group: recieving placebo(4 placebo tablets containing starch, magnesium stearate, calcium carbonate and maltodextrin made by the Faculty of Pharmacy of Guilan University of Medical Sciences) is given orally every night for 5 nights. Yes - There is a plan to make this available What will be shared: After collecting and analyzing the data, the results are available to the public in the form of articles When: after publication and for 6 months To whom: people working in academic institutions Conditions: There are no restrictions Where to obtain: Dr Malek Moien Ansar How to obtain: Request to Deputy of university Research and Technology of the Universityand the project supervisor Comments:
public Malek Moien Ansar
6th Km Gazvin- Rasht Road .Facuity of Medicine.Guilan University of Medical Sciences
Rash Iran (Islamic Republic of) 1376941996 +98 13 3369 0884 ansarmoien@gums.ac.ir Rasht University of Medical Sciences scientific Malek Moien Ansar
6th Km Gazvin- Rasht Road .Facuity of Medicine.Guilan University of Medical Sciences
Rash Iran (Islamic Republic of) 1376941996 +98 13 3369 0884 ansarmoien@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) RT-PCR test positive for SARS-CoV-2 criteria for patients with moderate symptoms:evidence of lower respiratory disease( dyspnea, Chest compression و..) oxygen saturation (SpO2) between 90 to 93% lung infiltrates<50% criteria for patients with sever symptoms: Dyspnea respiratory frequency >30 breaths/min oxygen saturation (SpO2) < 90% and PaO2/FiO2 <300 mm Hg lung infiltrates >50% 18 years no limit Both patients with mild symptoms diabetes hypertension pregnant women those who have already been in clinical trial with other drugs. Age less than 18 years U07.01 COVID-19 Disease Treatment - Other Treatment - Other Treatment - Other Intervention group1: 6 mg Melatonin (2 tablets of 3 mg melatonin made by Simorgh Pharmaceutical Company) is given orally every night for 5 nights Intervention group2: 12 mg of melatonin (4 tablets of 3 mg melatonin made by Simorgh Pharmaceutical Company) is given orally every night for 5 nights Control group: recieving placebo(4 placebo tablets containing starch, magnesium stearate, calcium carbonate and maltodextrin made by the Faculty of Pharmacy of Guilan University of Medical Sciences) is given orally every night for 5 nights. C-Reactive Protein serum levels. Timepoint: Morning of the first day (before the intervention), fourth day (day after the third intervention) and sixth day (day after the last intervention). Method of measurement: By ELISA. Erythrocyte sedimentation rate serum levels. Timepoint: Morning of the first day (before the intervention), fourth day (day after the third intervention) and sixth day (day after the last intervention). Method of measurement: erythrocyte sedimentation rate per hour. Outcome of the disease. Timepoint: Morning of the first day (before the intervention), fourth day (day after the third intervention) and sixth day (day after the last intervention). Method of measurement: Reduction of clinical sign and symptoms, no need for supplemental oxygen or mechanical ventilation. Ferritin. Timepoint: Morning of the first day (before the intervention), fourth day (day after the third intervention) and sixth day (day after the last intervention). Method of measurement: by ELISA. VitD(25OH). Timepoint: Morning of the first day (before the intervention), fourth day (day after the third intervention) and sixth day (day after the last intervention). Method of measurement: by ELISA. Days of hospitalization. Timepoint: Until discharge or death. Method of measurement: Based on the days of hospitalization. Rasht University of Medical Sciences Approved 2021-04-21 Ethics committee of Guilan University of Medical Sciences Deputy of university Research and Technology of the University Rasht Guilan Iran (Islamic Republic of)