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IRCT20200506047323N5 IRCT 2020-08-14 Bandare-abbas University of Medical Sciences Melatonin in COVID-19 Evaluation of the efficacy and safety of Melatonin in patients with COVID-19: a randomized clinical trial 2020-08-22 anticipated 60 Recruiting https://irct.ir/trial/50239 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be performed (each block consists 6 patients). Allocation sequence and concealment codes will be generated using www.sealedenvelope.com. The closed envelope method will be used to hide the allocation sequence, Blinding description: The medication and placebo will be coded by the project manager. Patients will be randomly allocated within the blocks based on the hidden codes, and study participants, physicians, and nurses who evaluate the outcomes will be blind to the intervention and studied groups. 3 COVID-19 disease. Intervention 1: Intervention group: The standard treatment for COVID-19 based on the Ministry of Health's protocol including hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days, along with melatonin capsules (Vana Darou Gostar Pharmaceutical Company, Iran) at a dose of 50 mg once a day for a period of seven days. Intervention 2: Control group: Hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days, along with melatonin-like placebo capsules (Vana Darou Gostar Pharmaceutical Company, Iran) at a dose of one capsule daily for a period of seven days. Yes - There is a plan to make this available What will be shared: Information regarding the study outcomes will be shared. When: Data will become available after publication of obtained results To whom: Only academic institutions Conditions: The study protocol or proposal should be approved by Ethics committee of institutions. The rights of authors and sponsors should be respected. Where to obtain: M.fathalipour@yahoo.com How to obtain: Requests should be addressed to the Technology and Research Vice-chancellery of Hormozgan University of Medical Sciences and the project executor should informed. Comments:
public Mohammad Fathalipour
Emam Hossein Blvd
Bandar Abbas Iran (Islamic Republic of) 7919691982 +98 76 3371 0406 m.fathalipour@hums.ac.ir Bandare-abbas University of Medical Sciences scientific Parivash Davoodian
Jomhuri Eslami Blvd
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3333 3280 parivash.davoodian@hums.ac.ir Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Age >20 years Positive polymerase chain reaction (PCR) test for COVID-19 or/and lung involvement in imaging Primary clinical symptoms Hospitalized and moderate patients Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm 20 years no limit Both Patients with underlying diseases including hypertension, diabetes, seizure, depression, chronic hepatitis, cirrhosis, and cholestatic liver diseases Use of anticoagulant drugs like warfarin, hormonal drugs, alcohol, and any illegal drugs (during last 30 days) History of allergy to Melatonin Pregnancy and breastfeeding U07.2 COVID-19, virus not identified Treatment - Drugs Treatment - Drugs Intervention group: The standard treatment for COVID-19 based on the Ministry of Health's protocol including hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days, along with melatonin capsules (Vana Darou Gostar Pharmaceutical Company, Iran) at a dose of 50 mg once a day for a period of seven days. Control group: Hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days, along with melatonin-like placebo capsules (Vana Darou Gostar Pharmaceutical Company, Iran) at a dose of one capsule daily for a period of seven days. Body temperature. Timepoint: Before intervention and daily during the study. Method of measurement: Thermometer. Respiratory rate. Timepoint: Before intervention and daily during the study. Method of measurement: Respiratory Count. Oxygen saturation. Timepoint: Before intervention and daily during the study. Method of measurement: Pulse oximeter. Lymphocytopenia. Timepoint: Before intervention and 7 days after the start of the intervention. Method of measurement: Cell count. C-reactive protein. Timepoint: Before intervention and 7 days after the start of the intervention. Method of measurement: C-RP kit. Incidence of serious adverse events. Timepoint: Before intervention and daily during the study. Method of measurement: Questionnaire. Bandare-abbas University of Medical Sciences Approved 2020-08-02 Ethics committee of Hormozgan University of Medical Sciences Jomhuri Eslami Blvd Bandar Abbas Hormozgan Iran (Islamic Republic of)