To assess if OPV can be used as a short-term preventive measure in human against SARS-CoV-2.
Design
Non-randomized non-blinded parallel design clinical trial on 130,000 people
Settings and conduct
Within 1 month, all people who receive health care services from Fars, Hormozgan and Ahwaz PIHO will be called upon to participate in this study. They will be given 4 drops of OPV by a medic after granting informed consents. No randomization or blinding used.
Participants/Inclusion and exclusion criteria
Population: All people receiving health care services from PIHO residing in Fars, Hormozgan, and Ahwaz centers.
Inclusion Criteria: All people receiving health care services from PIHO in the three provinces who agree to participate in the study.
Exclusion Criteria: Contraindication for receiving OPV.
Intervention groups
Single shot of OPV vaccination given to the eligible people
Main outcome variables
Adjusted Incidence (Risk) Ratio of COVID-19
General information
Reason for update
Acronym
COP
IRCT registration information
IRCT registration number:IRCT20140428017469N1
Registration date:2020-05-23, 1399/03/03
Registration timing:prospective
Last update:2020-05-23, 1399/03/03
Update count:0
Registration date
2020-05-23, 1399/03/03
Registrant information
Name
Farrokh Habibzadeh
Name of organization / entity
The IJOEM
Country
Iran (Islamic Republic of)
Phone
+98 71 1225 2258
Email address
farrokh.habibzadeh@theijoem.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-13, 1399/03/24
Expected recruitment end date
2020-07-14, 1399/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Short-term Protection for COVID-19 by Oral Polio Vaccine
Public title
Polio Vaccine and COVID-19
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All people receiving health care services from PIHO in the three provinces who agree to participate in the study (Fars, Hormozgan and Khuzestan).
Exclusion criteria:
All those with contraindication to receive OPV including immunocompromised people and those living with an immunocompromised person (including those with active malignancy receiving chemo/radiation therapy, transplant recipients receiving immunosuppressant drugs, those with active HIV infection, and those with congenital immunodeficiency).
Those with severe flu, high-grade fever, and history of allergy to other vaccines will be excluded too.
We will also exclude those who have newborn children who may be yet unimmunized against polio.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130000
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.SUMS.REC.1399.183
Street address
R&D Headquarters, PIHO, Eram Blvd, Shiraz 71438-37877, Iran
City
Shiraz
Province
Fars
Postal code
7143837877
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.SUMS.REC.1399.183
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
The age-adjusted incidence of COVID-19 in vaccinated people compared with that in unvaccinated general population (aRR).
Timepoint
2 months after vaccination
Method of measurement
daily count of new patients
Secondary outcomes
1
Description
The aged-adjusted incidence of vaccine-related side effects in vaccinated people compared with that in unvaccinated general population.
Timepoint
2-3 months after vaccination
Method of measurement
Counting those who may have side-effects
2
Description
To assess the age-adjusted mortality rate from COVID-19 in vaccinated people compared with that in unvaccinated general population.
Timepoint
2-3 months after vaccination
Method of measurement
Counting dead people
3
Description
To assess the disease severity in those with COVID-19 in vaccinated and unvaccinated people.
Timepoint
2-3 months after vaccination
Method of measurement
Assessed by the 8-point scale used by NIH
Intervention groups
1
Description
Intervention group: All people receiving health care services from PIHO residing in Fars, Hormozgan, and Ahwaz centers. The intervention group individuals will receive 4 drops of OPV vaccine (provided by Razi Institute). We will follow the age-adjusted incidence rate of COVID-19 in the study group for at least 2 months after the vaccination.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Petroleum Industry Health Organization
Full name of responsible person
Farrokh Habibzadeh
Street address
R&D Headquarters, Eram Blvd, Shiraz 7143837877, Iran
City
Shiraz
Province
Fars
Postal code
7143837877
Phone
+98 71 3225 2258
Email
Farrokh.Habibzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Petroleum Industry Health Organization
Full name of responsible person
Habibollah Sami
Street address
CEO, PIHO Headquarters, No 75, Behafarin St, Karim Khan Zand Blvd, Vali Asr Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1593816384
Phone
+98 21 8880 2459
Email
Sami@theijoem.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?