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IRCT20100601004076N27 IRCT 2022-01-02 Tehran University of Medical Sciences Evaluating the Safety and Effectiveness of Septimeb in Patients with COVID-19 Evaluating the Safety and Effectiveness of Septimeb in Patients with COVID-19 Referred to Selected Hospitals of Tehran University of Medical Sciences: A Clinical Trial Study (Phase III) 2022-01-21 anticipated 240 Complete https://irct.ir/trial/60750 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method is used. Random number table is a set of numbers that are generated completely randomly and are tabulated. Firstly, we determine the direction of the random number table and then we decide to read the random number table from above. Then we consider even numbers for the intervention group and odd numbers for the control group. We assign 240 codes from 1 to 240 to the patients hospitalized to the ward. Then we put patients with even code in the intervention group and patients with odd code in the control group. Thus, a total of 240 people will be assigned to the intervention and control groups. 3 COVID-19. Intervention 1: Intervention group: Patients will receive 10 ml (150 mg) of Septimib at the first day and 20 ml (30 mg) from the second day (minimum for one week and maximum for two weeks) in addition to national protocol treatments (including corticosteroids). Intervention 2: Control group: Treatment based on National Protocol. 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 Due to classified information of the patients
public Hamidreza Khorram Khorshid
Kodakyar Ave., Daneshjo Blvd., Evin
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7173 2000 hrkhkh@yahoo.com University of social welfare and rehabilitation sciences scientific SeyedAhmad SeyedAlinaghi
End of Keshavar Blvd., Imam Khomeini Hospital Complex, Basement of the Infection department (Building 6), Iranian Research Center for HIV/AIDS
Tehran Iran (Islamic Republic of) 1146546884 +98 21 6658 1583 s_a_alinaghi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Informed and voluntary oral and written consent of the patient or his / her guardian to participate in the study Age over 18 years SARS-CoV-2 virus PCR test positive or having one of the following conditions: Strong symptoms of COVID-19 disease, including fever, dry cough, and shortness of breath CT scan (HRCT or Spiral CT) that shows involvement with Cornavirus (at least 40% of lung involvement), especially ground glass in the peripheral or base of the lungs Patients suffering from life-threatening complications due to COVID-19 disease including ARDS, myocarditis, sepsis, cytokine storm (with ESR above 100 or platelet decline over 3 days or elevated D-Dimer above normal or LDH above normal). 18 years no limit Both Individuals whose Covid-19 test has not been approved Individuals who use drugs Individuals who drink alcohol Individuals who use immunosuppressive drugs Individuals under chemotherapy or radiotherapy Individuals who use growth hormone, testosterone and anabolic steroids The patient is pregnant or breastfeeding. B34.2 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive 10 ml (150 mg) of Septimib at the first day and 20 ml (30 mg) from the second day (minimum for one week and maximum for two weeks) in addition to national protocol treatments (including corticosteroids). Control group: Treatment based on National Protocol Morbidity. Timepoint: At the time of hospitalization, every 3 days until the day of discharge from the hospital. Method of measurement: Vital Signs Examination. Fever. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Headache. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Nausea. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Shivering. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Rhinitis. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Dry Cough. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Myalgia. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Diarrhea. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Shortness of breath. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Weakness and lethargy. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Blood Pressure. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. O2 saturation rate. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Clinical Examination. Complete blood count and differentiation. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Laboratory Test. C-reactive Protein. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Laboratory Test. Erythrocyte sedimentation rate (ESR). Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Laboratory Test. Alanine Aminotransferease (ALT). Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Laboratory Test. Aspartate aminotransferase (AST). Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Laboratory Test. Creatinine Test. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Laboratory Test. Di-Dimer Test. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Laboratory test. Presence of ground-glass appearance. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Chest X-ray. Alveolar Complication. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Chest X-ray. Unilateral or bilateral pulmonary involvement. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Chest X-ray. Location of Involvement. Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Chest X-ray. Presence of Acute respiratory distress syndrome (ARDS). Timepoint: At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge. Method of measurement: Chest X-ray. Tehran University of Medical Sciences Approved 2021-12-12 Ethics Committee of Tehran University of Medical Sciences Iranin Research Center for HIV/AIDS, Qarib street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)