Evaluation of safety and efficacy of FLUVAR® in prevention of COVID-19 compared to COLDAMARIS® and the control group in healthy population
Design
Phase 3, three parallel arms, double blinded, non-randomized, clinical trial on 1000 healthy volunteers
Settings and conduct
On the healthy volunteers at risk of COVID-19
Blinding: The researcher is unaware of which drug or placebo is being delivered / The drugs formulator is unaware of the recipients / The prescriber of the drugs is unaware of the grouping and content of the containers /The collector of outcomes and the analyst are unaware of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 years and older- Signing informed consent
Exclusion criteria: History of moderate or acute respiratory asthma- Participating in another clinical trial for COVID-19
Intervention groups
FLUVAR® nasal spray group 500µl once a week
COLDAMARIS® group 500 µl once a week
Drug-free control group
Main outcome variables
Rate of COVID-19 infection ( Time Frame: 14-20 months )
Acquisition of COVID-19 infection as confirmed by positive PCR swab taken 3-5 days after symptom onset
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200404046932N2
Registration date:2021-10-30, 1400/08/08
Registration timing:registered_while_recruiting
Last update:2021-10-30, 1400/08/08
Update count:0
Registration date
2021-10-30, 1400/08/08
Registrant information
Name
Leila Safaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7087
Email address
leila_safaeian@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of FLUVAR® in respiratory dosage form on the prevention of COVID-19 respiratory infection
Public title
Preventive effect of FLUVAR® on COVID-19
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and older
Informed consent
Exclusion criteria:
History of moderate or severe asthma
Participating in another clinical trial for COVID-19
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
1000
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher is unaware of which drug is delivered to which volunteer. The formulator of the two drugs is unaware of the recipients of the drugs and the dispenser of the drugs is unaware of the grouping and content of the drugs. The collector of results and the analyzer of data are also unaware of the type of drug groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Ethics Committee of Isfahan University of Medical Sciences, Hezarjarib Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-04-05, 1399/01/17
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.014
Health conditions studied
1
Description of health condition studied
COVID-19 Prophylaxis
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified
Primary outcomes
1
Description
Rate of COVID-19 infection
Timepoint
Time Frame: 14-20 months after admission to the study
Method of measurement
Acquisition of COVID-19 infection as confirmed by positive PCR swab taken 3-5 days after symptom onset
Secondary outcomes
1
Description
Duration and intensity of COVID-19 symptoms of infected participants
Timepoint
Two weeks after onset of disease symptoms
Method of measurement
Questionnaire of symptoms, duration and intensity of disease
2
Description
Side effects of intervention
Timepoint
Duration of Study
Method of measurement
Questionnaire of side effects
Intervention groups
1
Description
Intervention group 1: Three puffs of FLOVAR® spray on each side, equivalent to a total of 500µl of medicine, once a week and receiving an additional dose of medicine in case of contact with a person suspected of having Covid 19 or disease carrier
Category
Prevention
2
Description
Intervention group 2: Three puffs of COLDAMARIS® spray on each side, equivalent to a total of 500µl of medicine, once a week and receiving an additional dose of medicine in case of contact with a person suspected of having Covid 19 or disease carrier
Category
Prevention
3
Description
Control group: Without medicine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals of Isfahan University of Medical Sciences
Full name of responsible person
Leila Safaeian
Street address
Isfahan University of Medical Sciences, Hezarjarib BLVD
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7087
Email
leila_safaeian@pharm.mui.ac.ir
2
Recruitment center
Name of recruitment center
Sheikh bahaei Technology Park, Isfahan Science & Technology Town
Full name of responsible person
Hamid Mahdavi
Street address
Sheikh Bahaei Technology Park,Isfahan Science & Technology Town
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3387 1747
Email
hmahdavi@istt.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hakiman e Shargh Research Co.
Full name of responsible person
Sayyed Ali Alavi
Street address
Technology Park, Isfahan Science & Technology Town
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3667 1780
Email
sayyedalialavi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hakiman e Shargh Research Co.
Proportion provided by this source
100
Public or private sector
Private
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
Esfahan University of Medical Sciences
Full name of responsible person
Leila Safaeian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Isfahan Medical University
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7087
Fax
Email
leila_safaeian@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hakiman e Shargh Research Co.
Full name of responsible person
Sayyed Ali Alavi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Technology Park, Isfahan Science & Technology Town, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3667 1780
Email
Sayyedalialavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hakiman e Shargh Research Co.
Full name of responsible person
Sayyed Ali Alavi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Technology Park, Isfahan Science & Technology Town, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3667 1780
Email
Sayyedalialavi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Protection of participants' confidential medical information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The study protocol is provided after designing and loading the drug website.
When the data will become available and for how long
For 6 months from the time the data is uploaded to the drug site
To whom data/document is available
Applicants after applying through the site and receiving the approval of the executor
Under which criteria data/document could be used
For scientific purposes only - Non-commercial
From where data/document is obtainable
Drug website
What processes are involved for a request to access data/document
Registration - Registration of application - Verification of identity - Receipt of approval of the executor