- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04350931
Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nine hundred healthcare workers will be randomly assigned to receive intradermal injection of either BCG vaccine or normal saline.
During the study:
- Mantoux Tuberculin skin testing (will be done prior to administration of the BCG vaccine in the first group by intradermally injecting 0.1 mL of liquid containing 5 TU (tuberculin units) of purified protein derivative (PPD) in the volar aspect of the left forearm. The test is being read after 48-72 hrs. A positive tuberculin test is defined as induration ≥10 mm.
- Participants will be assessed clinically on daily basis for COVID 19 infection in the form of: fever, dry cough, fatigue, & dyspnea.
- PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study.
- The duration of follow-up for each participant depends on the interim results of the primary endpoint and the probability of obtaining a result, with a maximum of 6 months.
Randomization method:
A block-randomization scheme will be generated by computer software. Participants will be randomized between 0.10 mL intradermal injection of BCG vaccine or placebo normal saline in a 2:1 ratio (600 will receive BCG & 300 will receive placebo saline). In Egypt, the available BCG vaccine is the Copenhagen (Danish strain).
End point of the study:
- Primary endpoint: Confirmed COVID-19 infection
- Secondary endpoint: number of days of (unplanned) absenteeism for any reason.
- Tertiary endpoints: number of days of (unplanned) absenteeism because of documented COVID-19 infection, and the cumulative incidence of hospital admission, ICU admission, and mortality.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Iman Hassan, MD
- Phone Number: 002 01001502179
- Email: dr.imangalal@gmail.com
Study Contact Backup
- Name: Fatma Soliman E Ebeid
- Phone Number: 002 01095569596
- Email: dr.fatma_ebeid@yahoo.com
Study Locations
-
-
Non-US
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Cairo, Non-US, Egypt, 11566
- Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy healthcare workers defined as nurses and physicians working at emergency rooms, ICUs, and wards of isolation hospitals
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: BCG Vaccine
0.10 mL intradermal injection of BCG Vaccine over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the left upper arm) slowly over 10 seconds (In Egypt, the available BCG vaccine is the Copenhagen BCG vaccine - The Danish Strain 1331 of Mycobacterium Bovis).
Each 0.10 mL vaccine contains 200000-800000 colony forming units.
|
0.10 mL intradermal injection of BCG Vaccine over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the left upper arm) slowly over 10 seconds
|
PLACEBO_COMPARATOR: intradermal normal saline
placebo 0.10 mL intradermal normal saline (0.9% NaCl) over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the left upper arm) slowly over 10 seconds.
|
placebo 0.10 mL intradermal normal saline (0.9% NaCl) over the distal insertion of the deltoid muscle onto the humerus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of confirmed COVID-19
Time Frame: 9 months
|
Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals
|
9 months
|
Effectiveness of BCG vaccine
Time Frame: 9 months
|
Evaluate the effectiveness of BCG vaccine in protecting the healthcare workers in isolation hospitals against the risk of COVID-19 infection by detecting any positive cases among vaccinated healthscare workers
|
9 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- BCG Vaccine
Other Study ID Numbers
- FMASU P19a/ 2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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