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IRCT20170128032241N3 IRCT 2020-08-17 Shahid Beheshti University of Medical Sciences Evaluation the Efficacy of CURCUDEN 35 in Patients with COVID-19 Evaluation the Efficacy of CURCUDEN in Patients with COVID-19 Pneumonia 2020-05-21 anticipated 20 Complete https://irct.ir/trial/47031 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the table of random numbers, we assign patients codes in the specified range, then categorize the individual codes into the intervention group and the pair codes into the control group. The central randomizing method is used for allocation concealment. For this purpose, even and odd codes are provided to the researcher conducting the project, and sampling is performed in the medical center of Taleghani Hospital. Based on the order in which the participants entered the study, the researcher randomly assigned the participant to one of the two groups of treatment and control (even and odd codes). At the end of the study, and after the intervention, unblinding will be done with the Post-study unblinding model to prevent any bias in the study, Blinding description: We mark drug with code A and placebo with the code B, only the analyst is aware of this codes, each group of patients receive A or B randomly, the physician and the patient are not aware of this codes. 3 covid-19 pneumonia Disease. Intervention 1: Intervention group: Patients with covid-19 who use curcumin in addition to first-line drugs during treatment. Intervention group receive two capsules of CURCUDEN® every 12 hours in addition to the main treatment based on national guidelines for the treatment of hospitalized patients with COVID-19. Curcuden 35 is a drug used by Alborz Nanomed tech Company. Intervention 2: Control group: Patients with covid-19 who use placebo in addition to first-line drugs during treatment. Control group receive two capsules of placebo every 12 hours in addition to the main treatment based on national guidelines for the treatment of hospitalized patients with COVID-19. 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 No more information
public Mehran Azodi
No.122, Dr. Hooshyar St., Azadi Ave., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1341879796 +98 21 6605 7174 mohajeri_maryam@yahoo.com Alborz Nanomed Tech. Co. scientific Maryam Mohajeri
No. 122, Dr.HoosSt., Azadi Ave., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1341879796 +98 21 6600 0561 mohajeri_maryam@yahoo.com Alborz Nanomed Tech Co. Iran (Islamic Republic of) Virological diagnosis of SARS-CoV-2 infection by RT-PCR Positive imaging findings: Condensation, Grand Glass opacity or bilateral pulmonary infiltration on CT scan or Chest X-ray Need to get extra oxygen to maintain SO2> 94% or PaO2 / FiO2> 300 18 years no limit Both Age less than 18 years The patient has septic shock Pregnancy and lactation The patient is intubated and under mechanical ventilation The patient was admitted to the ICU Having an allergy to curcumin U07.1 covid-19 pneumonia Treatment - Drugs Placebo Intervention group: Patients with covid-19 who use curcumin in addition to first-line drugs during treatment. Intervention group receive two capsules of CURCUDEN® every 12 hours in addition to the main treatment based on national guidelines for the treatment of hospitalized patients with COVID-19. Curcuden 35 is a drug used by Alborz Nanomed tech Company. Control group: Patients with covid-19 who use placebo in addition to first-line drugs during treatment. Control group receive two capsules of placebo every 12 hours in addition to the main treatment based on national guidelines for the treatment of hospitalized patients with COVID-19. 1- Evaluation of clinical variables involved in patients' recovery including mechanical ventilation. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Spirometry test. 2- Organ failure and comparison of these results in the two groups of treatment and control. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Examination and registration of clinical signs. 3- Mortality and comparison of these results in the two groups of treatment and control. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Record vital signs. 4- The length of hospital stay and comparison of these results in the treatment and controlgroups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Evaluation of the length of hospital stay. 5- Length of ICU hospitalization and comparison of these results in the treatment and controlgroups. Timepoint: On days 1 and 5 of the start of treatment. Method of measurement: Check the period of hospitalization in the ICU. 6- Receiving oxygen and comparing these results in the treatment and control groups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Nursing information on the use of oxygen capsules. 7- The length of the negative period of PCR test and comparison of these results in thetreatment and control groups. Timepoint: On days 1 and 14 of the start of treatment. Method of measurement: Polymerase Chain Reaction. 8- Comparison of interleukin-6 levels in the treatment and control groups. Timepoint: On days 1 and 14 of the start of treatment. Method of measurement: Polymerase Chain Reaction. 9- Comparison of patients' ferritin levels in treatment and control groups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Blood biochemical test. 10- Comparison of patients' CRP levels in treatment and control groups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Blood biochemical test. 11- Length of improvement period of patients' lung imaging results and comparison of results intreatment and control groups. Timepoint: On days 1 and 5 of the start of treatment. Method of measurement: lung CT Scan. 12- Lymphocyte count and comparison of results in treatment and control groups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Blood biochemical test. 13- Length of respiratory symptoms and comparison of results between treatment and controlgroups. Timepoint: On days 1, 5 and 14 of the start of treatment. Method of measurement: Check spirometric test information. Shahid Beheshti University of Medical Sciences Mobtaker Electric Company ( METEC ) Alborz Nanomed-Tech Company Approved 2020-05-10 Ethics committee of Shahid Beheshti Medical University 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)