Effects of organic boron - sugar complex (as Calcium Fructoborate) supplement on the severity and consequences of COVID-19 in inpatient cases: A double blind Clinical Trial
Effects of organic boron - sugar complex (as Calcium Fructoborate) supplement on the severity and consequences of COVID-19 in inpatient cases.
Design
Clinical trial with control group with parallel groups, phase 2 on 300 patients
Settings and conduct
This study will performed on confirmed Covid-19 patients in Bu Ali Sina and Velayat hospitals in Qazvin. All patients will receive standard treatment based on recommendations of the national COVID-19 treatment guidelines. In the intervention group, calcium fructoborate solution and in the control group, placebo solution with similar taste, color and appearance will be given and the mortality rate and length of hospital stay will be recorded and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definitive cases of Covid-19 confirmed by positive PCR test on nasopharyngeal secretions.
Exclusion criteria:
Age younger than 19 or older than 80 years old.
Suspected to have bacterial respiratory infections in the beginning of study
Suffering from serious chronic diseases
pregnancy
Receiving drugs that are not recommended in national guidelines for COVID-19 treatment (including steroids higher than dexamethasone 8 mg daily equivalent, IVIG, plasmaphresis, serum therapy, hemoperfusion, pirfinidone) during the study period for any reason.
Intervention groups
Drug group: Patients receiving standard diet of Covid 19 plus a syrup containing organic-sugar boron complex (as calcium fructoborate) containing 430 mg in 5 ml
Placebo group: Ppatients receiving the standard treatment regimen for Covid 19 plus placebo syrup with the same color and taste as the calcium fructoborate syrup
Main outcome variables
Mortality rate and length of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090803002276N4
Registration date:2021-10-29, 1400/08/07
Registration timing:prospective
Last update:2021-10-29, 1400/08/07
Update count:0
Registration date
2021-10-29, 1400/08/07
Registrant information
Name
Behzad Bijani
Name of organization / entity
Qazvin University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 4808
Email address
bbijani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-01, 1400/08/10
Expected recruitment end date
2022-01-30, 1400/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of organic boron - sugar complex (as Calcium Fructoborate) supplement on the severity and consequences of COVID-19 in inpatient cases: A double blind Clinical Trial
Public title
Evaluation of impact of Calcium Calcium Fructoborate in patients admitted with the diagnosis of COVID19 infection.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Admission in the hospital with a positve PCR test for COVID-19
Age between 19 and 80 years
Exclusion criteria:
Patients suspected to bacterial infections in the first day of admission
suffering severe chronic diseases
pregnancy
consumption of medications not recommended in national COVID-19 guideline.
Age
From 19 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule is used for allocation of patients to intervention and control groups. one hundred fifty pieces of paper will be marked as intervention and control and placed in a bag. In the first day of admission, one of papers is pulled out randomly and according to the word written on the paper, the participant will be placed in one of the two groups. Neither the patient nor the chief researcher will be notified of their assignment to the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
During the process of allocation of patients to intervention and placebo groups, only the clinical caregivers will be notified of the individual's allocation to the drug or placebo group. There is no difference between the drug and the placebo in terms of shape and taste and the patient will not notice his/her group at all. Outcome assessors also do not know to what group each patient belongs to. Statistical analysts and authors of the draft article, identify the patients only by a number and their name will remain completely unknown to them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Research deputy of Qazvin University of Medical Sciences, first alley, Maveddat St, Shaheed Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
۳۴۱۵۶۱۳۹۱۱
Approval date
2021-09-18, 1400/06/27
Ethics committee reference number
IR.QUMS.REC.1400.260
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Mortality rate
Timepoint
from including to study to 30 days
Method of measurement
Observation
2
Description
Hospital stay
Timepoint
After discharge
Method of measurement
Patient hospital record
Secondary outcomes
1
Description
َArterial Oxygen Saturation
Timepoint
Daily
Method of measurement
Pulse oxymeter device
2
Description
Respiratory rate
Timepoint
Daily
Method of measurement
Counting the number of breaths per minute
3
Description
Leukocyte count
Timepoint
Every three days
Method of measurement
Cell counter device
4
Description
Lymphocyte percentage
Timepoint
Every three days
Method of measurement
Cell counter device
5
Description
Serum electrolites
Timepoint
Every three days
Method of measurement
Flame photometer device
6
Description
Quantitative C reactive Protein
Timepoint
Every three days
Method of measurement
Turbidometer device
Intervention groups
1
Description
Intervention group: Standard therapeutic regimen for COVID-19 and a dose of 5 milliliter of a syrup containing 430 mg Calcium fructoborate solution prepared by Arnica daru Danesh Adrin Co. prescribed daily by oral route from the first day of admission to completion of ten days.
Category
Treatment - Drugs
2
Description
Control group: Standard therapeutic regimen for COVID-19 and a dose of placebo as syrup prepared by Arnica daru Danesh Adrin Co. with the same color, odour, taste and volume of the the syrup prescribed for the intervention group for daily oral use till 10 days, for patients in control group.
No 1, Andishnandan Blvd, Shaheed Babayee Blvd, Barajin
City
قزوین
Province
Qazvin
Postal code
3471991984
Phone
+98 28 3335 4808
Email
mohsen_hattami@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arnica darou danesh adrin
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Behzad Bijani
Position
Assiciate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
47 Bahram Alley, Hokmabad St.
City
قزوین
Province
Qazvin
Postal code
3145616666
Phone
+98 28 3335 4808
Email
dr.bijani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Behzad Bijani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
47 Bahram Alley, Hokmabad St.
City
Qazvin
Province
Qazvin
Postal code
3415616666
Phone
+98 28 3335 4808
Email
dr.bijani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Behzad Bijani
Position
Assiciate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
47 Bahram Alley, Hokmabad St.
City
قزوین
Province
Qazvin
Postal code
3415616666
Phone
+98 28 3335 4808
Email
dr.bijani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data, after the individuals are unidentified, can be shared
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific purposes
From where data/document is obtainable
Website of the Research Committee of Qazvin University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.