Determine the effect of NBS powder on immune system function and clinical manifestations in patients with COVID-19
Design
The randomized clinical trial, parallel groups, 23 patients will be enrolled in each arms of the study.
Settings and conduct
This study will be performed in Sina hospital, Hamadan, Iran. In this study 46 patients selected based on inclusion and exclusion criteria will be divided into two groups (23 in each group) by simple randomization. Patients in control group will be prescribed standard regimen for COVID-19. Patients in intervention group in addition to the standard antiviral treatment of the two-drug regimen, NBS powder will be taken at a dose of 2 g / day for 4 weeks.
Participants/Inclusion and exclusion criteria
The confirmed COVID-19 patients through PCR over the age of 20 year and is not allergic to the powder used.
Intervention groups
In the intervention group, in addition to the standard antiviral treatment of the two-drug regimen, NBS powder will be taken at a dose of 2 g / day for 4 weeks. The control group will only receive standard antiviral treatment with a two-drug regimen.
Main outcome variables
Improve clinical signs and strengthen the immune system
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200426047206N1
Registration date:2020-04-28, 1399/02/09
Registration timing:prospective
Last update:2020-04-28, 1399/02/09
Update count:0
Registration date
2020-04-28, 1399/02/09
Registrant information
Name
Salman Khazaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0548
Email address
salman.khazaei61@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2020-07-10, 1399/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Nutrition Bio-Safety (NBS) powder on immune system function and clinical manifestations in patients with COVID-19
Public title
The effect of NBS powder in treatment of patients with COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Covid 19 positive patients with with age over 20 years
Exclusion criteria:
Disagreement of the patient or relatives to participate in the project
Drug sensitivity to NBS
Patient death during common and selective treatments
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method will be used. A randomized list will be generated by online randomization site. Patients will be allocated to intervention or control group according to the generated list.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients and researchers don't know which group of patients will use the NBS. Physician and clinicians team know about the group who use the powder.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838778
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.UMSHA.REC.1399.046
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
U07.2
ICD-10 code description
COVID-19,
Primary outcomes
1
Description
Pulmonary symptoms
Timepoint
4 weeks after intervention
Method of measurement
CT Scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in intervention group in addition to the standard antiviral treatment of the two-drug regimen, NBS powder will be prescribe is below: Dosage of NBS is 500 mg capsules daily in four capsules (two grams) given in divided doses of one gram in the morning and one gram in the evening for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: standard antiviral treatment of the two-drug regimen including: Hydroxychloroquine - Caltra (Lupinavir + Ritonavir)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Farid Azizi Jalilian
Street address
Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
657838678
Phone
+98 81 3838 0548
Email
azizifarid@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6571838678
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farid Azizi Jalilian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
azizifarid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farid Azizi Jalilian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
azizifarid@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farid Azizi Jalilian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
azizifarid@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available