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OPV as Potential Protection Against COVID-19

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ClinicalTrials.gov Identifier: NCT04445428
Recruitment Status : Enrolling by invitation
First Posted : June 24, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Bandim Health Project

Tracking Information
First Submitted Date  ICMJE June 22, 2020
First Posted Date  ICMJE June 24, 2020
Last Update Posted Date July 16, 2020
Actual Study Start Date  ICMJE July 15, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
Mortality or infectious disease causing consultation or admission (Composite outcome) [ Time Frame: 6 months ]
Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • Self-reported morbidity [ Time Frame: 6 months ]
    Episodes with self-reported infectious disease morbidity.
  • Suspected COVID-19 infection [ Time Frame: 6 months ]
    Episodes with self-reported infectious disease morbidity suspected to be caused by COVID (three or more of the following: fever, cough, sore thought, extreme fatigue, loss of smell/taste).
  • Mortality [ Time Frame: 6 months ]
    Either of the components of the composite outcome.
  • Hospital admission for infectious disease [ Time Frame: 6 months ]
    Either of the components of the composite outcome included repeated events.
  • Consultations for infectious disease [ Time Frame: 6 months ]
    Either of the components of the composite outcome included repeated events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OPV as Potential Protection Against COVID-19
Official Title  ICMJE Oral Polio Vaccine as Potential Protection Against COVID-19: A Cluster-randomised Trial in Guinea-Bissau
Brief Summary

Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio. Such beneficial non-specific effect have been observed for other live vaccines, including measles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has been studied the most, the effects appear to be mediated through the innate immune system. The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1 million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated that in Africa the older part of the population will be at risk of severe COVID-19. OPV is widely used in Africa, but for children. Both polio and coronavirus are positive-strand RNA viruses, therefore it is likely that they may induce and be affected by common innate immune mechanisms.

In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description:
Participants are cluster randomised to OPV or no vaccine. Information on group assignment is not available to health center staff and staff at the health and demographic surveillance system
Primary Purpose: Prevention
Condition  ICMJE
  • Poliovirus Vaccine, Oral
  • COVID
  • Mortality
  • Morbidity
  • Non-Specific Effects of Vaccines
Intervention  ICMJE
  • Biological: oral polio vaccine + information
    Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
  • Behavioral: Information
    Advice regarding how to protect oneself from COVID-19
Study Arms  ICMJE
  • Experimental: Intervention
    Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19
    Interventions:
    • Biological: oral polio vaccine + information
    • Behavioral: Information
  • Control
    Information regarding prevention of COVID-19
    Intervention: Behavioral: Information
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 22, 2020)
3400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Living in a household which has had a census visit conducted after 1 January in 2017. Age above 50.

Exclusion Criteria:

  • Previous adverse events to OPV; Previous documented COVID-19; Acute severe infection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Guinea-Bissau
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04445428
Other Study ID Numbers  ICMJE 77/CNES/INASA/2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Provided request, data can be made available
Responsible Party Bandim Health Project
Study Sponsor  ICMJE Bandim Health Project
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ane Fisker, MD, PhD Bandim Health Project
PRS Account Bandim Health Project
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP