Status:
UNKNOWN
Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19
Lead Sponsor:
Ain Shams University
Conditions:
Coronavirus Disease (COVID-19)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Phase III Placebo-controlled adaptive multi-centre randomized controlled trial Interventional (Clinical Trial). The study will include nine hundred healthcare workers in the isolation hospitals for CO...
Detailed Description
Nine hundred healthcare workers will be randomly assigned to receive intradermal injection of either BCG vaccine or normal saline. During the study: 1. Mantoux Tuberculin skin testing (will be done ...
Eligibility Criteria
Inclusion
- Healthy healthcare workers defined as nurses and physicians working at emergency rooms, ICUs, and wards of isolation hospitals
Exclusion
- Immunosuppression
- Pregnancy \& lactation
- Chronic underlying medical illness
- Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
- Known active or latent Mycobacterium tuberculosis or with another mycobacterial species.
- Fever (\>38 C) within the past 24 hours
- Current bacterial infection
- Recent viral infection
- Refusal of doing tuberculin test in the first group
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04350931
Start Date
April 20 2020
End Date
December 1 2020
Last Update
April 20 2020
Active Locations (1)
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1
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt, 11566