Protocol summary
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Study aim
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Evaluating the effect of the combination of BCc1 & Hep-S on the improvement of clinical & laboratory symptoms of hospitalized COVID-19 patients
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Design
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Clinical trial involving a control group with parallel , double blind groups randomized according to block randomization form at phases 1&2 on 120 patients
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Settings and conduct
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- Place: wards for hospitalized COVID-19 patients
- Method: by blinding the patients and the clinician
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: hospitalized definite COVID-19 patients diagnosed via 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
Exclusion criteria: pregnancy, in lactation, patients with transplants, hereditary immunodeficiency, patients with a record of type 1 diabetes, addiction to alcohol or drugs
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Intervention groups
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1. Hospitalized COVID-19 patients: the patients would receive the standard COVID-19 regimen along with BCc1 nanomedicine in 3 servings per day according to the presented dosage.
2. Hospitalized COVID-19 patients: the patients would receive the standard COVID-19 regimen along with Hep-s in 3 servings per day according to the presented dosage.
3. Hospitalized COVID-19 patients: the patients would receive the standard COVID-19 regimen along with the combination of BCc1 & Hep-s in 3 servings per day according to the presented dosage.
4. Hospitalized COVID-19 patients: the patients would receive the standard COVID-19 regimen along with placebo in 3 servings per day according to the presented dosage.
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Main outcome variables
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Hospitalization period, morality, CT scan images of the lungs,
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170731035423N2
Registration date:
2020-06-12, 1399/03/23
Registration timing:
registered_while_recruiting
Last update:
2020-10-21, 1399/07/30
Update count:
1
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Registration date
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2020-06-12, 1399/03/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-05-21, 1399/03/01
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Expected recruitment end date
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2021-03-20, 1399/12/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of the combination of BCc1 & Hep-S on hospitalized COVID-19 patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
Pregnancy
In lactation
Addiction to alcohol or drugs
Patients with transplants
Patients with a record of type 1 diabetes
Hereditary immunodeficiency
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Age
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From 20 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-07, 1399/02/18
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Ethics committee reference number
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IR.SBMU.CRC.REC.1399.001
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Hospitalization period
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Timepoint
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Hospitalization period
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Method of measurement
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Counting hospitalization days
2
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Description
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Mortality
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Timepoint
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Before and after being released
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Method of measurement
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Observation
3
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Description
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CT scan images of the lungs
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Timepoint
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Before hospitalization & 2 weeks after
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Method of measurement
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CT scan images
4
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Description
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Clinical indices
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Timepoint
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Before intervention, 3 & 6 days after intervention and before being released
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Method of measurement
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Questionnaire
5
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Description
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CT scan of the lungs
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Timepoint
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Before the start of the intervention, before being released & 2 weeks after
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Method of measurement
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CT scan machine
Secondary outcomes
1
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Description
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CRP
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Timepoint
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Before intervention, 3 & 6 days after intervention and before being released
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Method of measurement
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Biochemical methods
2
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Description
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ESR
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Timepoint
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Before intervention, 3 & 6 days after intervention and before being released
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Method of measurement
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Biochemical methods
3
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Description
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Oxygen saturation in patients
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Timepoint
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Before intervention, every day after intervention and before being released
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Method of measurement
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Pulse oximetry
4
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Description
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CBC
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Timepoint
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Before intervention, 3 & 6 days after intervention and before being released
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Method of measurement
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Biochemical methods
5
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Description
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SGOT & SGPT enzymes
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Timepoint
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Before intervention & before being released
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Method of measurement
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Biochemical methods
6
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Description
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PCR test
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Timepoint
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Before intervention & before being released
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Method of measurement
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Molecular methods
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
3
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Description
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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.
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Category
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Treatment - Devices
4
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences, Cancer Research Center
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sodour Ahrar Shargh Knowledge-based Company
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The patients' CRF will be published.
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When the data will become available and for how long
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After completing the project
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To whom data/document is available
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Only for researchers working in academic & scientific institutes
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Under which criteria data/document could be used
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Upon request & if approved by the researcher in charge
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From where data/document is obtainable
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Via sending an email to the senior R&D expert at Sodour Ahrar Shargh Knowledge-based Company:
mhafizi@nanochelatingtechnology.com
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What processes are involved for a request to access data/document
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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.
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Comments
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