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IRCT20170731035423N2 IRCT 2020-06-12 Shahid Beheshti University of Medical Sciences, Cancer Research Center Effect of the combination of BCc1 & Hep-S on hospitalized COVID-19 patients Effect of the combination of BCc1 & Hep-S on the improvement of clinical & laboratory symptoms of hospitalized COVID-19 patients in a randomized, double-blind, clinical trial 2020-05-21 anticipated 120 Complete https://irct.ir/trial/48049 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random number table would be used for randomization. Therapeutic regimens would be classified into 4 groups of A, B, C and D. We start from the first number on the right side of the table and move downward. If the first number on the right is 1 & 2, we prescribe regimen A, if it is 3 & 4, regimen B, if it is 5 & 6, regimen C, and if it is 7 & 8, regimen D. In case the number is 9 or 0, we leave them and consider the next number. We continue doing this until the sample size of the group is complete, and then move forward to the next group, Blinding description: The medical staff (doctors & nurses), the researcher and the clinician would be blinded by labeling the syrup bottles with unidentified content. The physician who provides the patients with the syrup bottles would be unaware of the content and randomly assign the patients to 4 groups through pre-designed block randomization form. 3 COVID-19. Intervention 1: Intervention group 1 – Medicine: chelated mixture named BCc1. Number & content: a 250 cc bottle containing 200 cc medicine in the form of syrup. Chemical mixture: polymerized organic acid using nanochelating technology. Density: 500 mg of chelated mixture per 2 cc. Consumption dose: 3 servings per day (4 cc per serving). Direction for use: the consumption dose per serving should be diluted in 250 cc of water and consumed orally. Equipment: no special equipment is required. Patients will be provided with the medicine placed in 250 cc bottles along with a sterilized 15 cc falcon tube to measure the consumption dose. Consumption duration: hospitalization period. Manufacturing company: laboratory of Sodour Ahrar Shargh Knowledge-based Company. Intervention 2: Intervention group 2 – Medicine: chelated selenium mixture named Hep-s. Number & content: a 250 cc bottle containing 200 cc medicine in the form of syrup. Chemical mixture: polymerized organic acid using nanochelating technology. Density: 500 µg of chelated selenium mixture per 2 cc. Consumption dose: 3 servings per day. 12 cc on the first 3 days and 6 cc from day 4 onwards. Direction for use: the consumption dose per serving should be diluted in 250 cc of water and consumed orally. Equipment: no special equipment is required. Patients will be provided with the medicine placed in 250 cc bottles along with a sterilized 15 cc falcon tube to measure the consumption dose. Consumption duration: hospitalization period. Manufacturing company: laboratory of Sodour Ahrar Shargh Knowledge-based Company. Intervention 3: Intervention group 3 – Medicine: a package of BCc1 & Hep-s. Number & content: two separate 250 cc bottles for BCc1 & Hep-s, each containing 200 cc medicine in the form of syrup. Chemical mixture: polymerized organic acid using nanochelating technology. Density: 500 mg of chelated mixture per 2 cc for BCc1 & 500 µg of chelated selenium mixture per 2 cc for Hep-s. Consumption dose: 2 servings per day for BCc1 (6 cc per serving). One serving per day for Hep-s (12 cc on the first 3 days and 6 cc from day 4 onwards). Direction for use: the consumption dose per serving should be diluted in 250 cc of water and consumed orally. Equipment: no special equipment is required. Patients will be provided with the medicine placed in 250 cc bottles along with a sterilized 15 cc falcon tube to measure the consumption dose. Consumption duration: hospitalization period. Manufacturing company: laboratory of Sodour Ahrar Shargh Knowledge-based Company. Intervention 4: Control group – Medicine: ORS powder. Number & content: a 250 cc bottle containing 200 cc placebo in the form of syrup. Chemical mixture: glucose & sodium bicarbonate. Density: 50 mg ORS per 2 cc. Consumption dose: 3 servings per day. 2 cc per serving. Direction for use: the consumption dose per serving should be diluted in 250 cc of water and consumed orally. Equipment: no special equipment is required. Patients will be provided with the medicine placed in 250 cc bottles along with a sterilized 15 cc falcon tube to measure the consumption dose. Consumption duration: hospitalization period. Manufacturing company: Rouz Darou Company. Yes - There is a plan to make this available What will be shared: The patients' CRF will be published. When: After completing the project To whom: Only for researchers working in academic & scientific institutes Conditions: Upon request & if approved by the researcher in charge Where to obtain: Via sending an email to the senior R&D expert at Sodour Ahrar Shargh Knowledge-based Company: mhafizi@nanochelatingtechnology.com How to obtain: The documents, including information forms, reports, analyses results and statistical results, are kept by the researcher in charge. A request for data or documents should be emailed to the senior R&D expert (email address: m.hafizi6060@nanochelatingtechnology.com). Then, within 72 working hours and upon the approval of the request by the researcher in charge, the requested documents would be sent to the requester. Comments:
public Maryam Hafizi
No.1, Afshin Alley, Abdollahzadeh St., Keshavarz Blvd., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1415944341 +98 21 8899 2123 mhafizi@nanochelatingtechnology.com Sodour Ahrar Shargh Knowledge-based Company scientific Alireza Fatemi
Shohadaye Tajrish Hospital, Shahrdari St., Tajrish Sq.
Tehran Iran (Islamic Republic of) 1415944341 +98 21 8899 2123 alireza.fatemi.md@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Hospitalized definite COVID-19 patients diagnosed by PCR & CT scan of the lungs Patients' filling out a consent form Patients won't be discharged within 48 hrs Patients' conditions won't be improving within 48 hrs 20 years no limit Both Pregnancy In lactation Addiction to alcohol or drugs Patients with transplants Patients with a record of type 1 diabetes Hereditary immunodeficiency U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Treatment - Devices Placebo Intervention group 1 – Medicine: chelated mixture named BCc1. Number & content: a 250 cc bottle containing 200 cc medicine in the form of syrup. Chemical mixture: polymerized organic acid using nanochelating technology. Density: 500 mg of chelated mixture per 2 cc. Consumption dose: 3 servings per day (4 cc per serving). Direction for use: the consumption dose per serving should be diluted in 250 cc of water and consumed orally. Equipment: no special equipment is required. Patients will be provided with the medicine placed in 250 cc bottles along with a sterilized 15 cc falcon tube to measure the consumption dose. Consumption duration: hospitalization period. Manufacturing company: laboratory of Sodour Ahrar Shargh Knowledge-based Company. Intervention group 2 – Medicine: chelated selenium mixture named Hep-s. Number & content: a 250 cc bottle containing 200 cc medicine in the form of syrup. Chemical mixture: polymerized organic acid using nanochelating technology. Density: 500 µg of chelated selenium mixture per 2 cc. Consumption dose: 3 servings per day. 12 cc on the first 3 days and 6 cc from day 4 onwards. Direction for use: the consumption dose per serving should be diluted in 250 cc of water and consumed orally. Equipment: no special equipment is required. Patients will be provided with the medicine placed in 250 cc bottles along with a sterilized 15 cc falcon tube to measure the consumption dose. Consumption duration: hospitalization period. Manufacturing company: laboratory of Sodour Ahrar Shargh Knowledge-based Company. Intervention group 3 – Medicine: a package of BCc1 & Hep-s. Number & content: two separate 250 cc bottles for BCc1 & Hep-s, each containing 200 cc medicine in the form of syrup. Chemical mixture: polymerized organic acid using nanochelating technology. Density: 500 mg of chelated mixture per 2 cc for BCc1 & 500 µg of chelated selenium mixture per 2 cc for Hep-s. Consumption dose: 2 servings per day for BCc1 (6 cc per serving). One serving per day for Hep-s (12 cc on the first 3 days and 6 cc from day 4 onwards). Direction for use: the consumption dose per serving should be diluted in 250 cc of water and consumed orally. Equipment: no special equipment is required. Patients will be provided with the medicine placed in 250 cc bottles along with a sterilized 15 cc falcon tube to measure the consumption dose. Consumption duration: hospitalization period. Manufacturing company: laboratory of Sodour Ahrar Shargh Knowledge-based Company. Control group – Medicine: ORS powder. Number & content: a 250 cc bottle containing 200 cc placebo in the form of syrup. Chemical mixture: glucose & sodium bicarbonate. Density: 50 mg ORS per 2 cc. Consumption dose: 3 servings per day. 2 cc per serving. Direction for use: the consumption dose per serving should be diluted in 250 cc of water and consumed orally. Equipment: no special equipment is required. Patients will be provided with the medicine placed in 250 cc bottles along with a sterilized 15 cc falcon tube to measure the consumption dose. Consumption duration: hospitalization period. Manufacturing company: Rouz Darou Company. Hospitalization period. Timepoint: Hospitalization period. Method of measurement: Counting hospitalization days. Mortality. Timepoint: Before and after being released. Method of measurement: Observation. CT scan images of the lungs. Timepoint: Before hospitalization & 2 weeks after. Method of measurement: CT scan images. Clinical indices. Timepoint: Before intervention, 3 & 6 days after intervention and before being released. Method of measurement: Questionnaire. CT scan of the lungs. Timepoint: Before the start of the intervention, before being released & 2 weeks after. Method of measurement: CT scan machine. CRP. Timepoint: Before intervention, 3 & 6 days after intervention and before being released. Method of measurement: Biochemical methods. ESR. Timepoint: Before intervention, 3 & 6 days after intervention and before being released. Method of measurement: Biochemical methods. Oxygen saturation in patients. Timepoint: Before intervention, every day after intervention and before being released. Method of measurement: Pulse oximetry. CBC. Timepoint: Before intervention, 3 & 6 days after intervention and before being released. Method of measurement: Biochemical methods. SGOT & SGPT enzymes. Timepoint: Before intervention & before being released. Method of measurement: Biochemical methods. PCR test. Timepoint: Before intervention & before being released. Method of measurement: Molecular methods. Sodour Ahrar Shargh Knowledge-based Company Shahid Beheshti University of Medical Sciences, Cancer Research Center Sodour Ahrar Shargh Knowledge-based Company Approved 2020-05-07 Ethics Committee of Shahid Beheshti University of Medical Sciences Shohadaye Tajrish Hospital, Shahrdari St., Tajrish Sq. Tehran Tehran Iran (Islamic Republic of)