Coronavirus Disease (COVID-19)
Conditions
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 COVID-19 cases; they will be randomly assigned to receive either BCG vaccine or normal saline.
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 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. 2. Participants will be assessed clinically on daily basis for COVID 19 infection in the form of: fever, dry cough, fatigue, & dyspnea. 3. PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study. 4. 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.
Interventions
BIOLOGICALintradermal injection of 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
OTHERplacebo
placebo 0.10 mL intradermal normal saline (0.9% NaCl) over the distal insertion of the deltoid muscle onto the humerus
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of confirmed COVID-19 | 9 months | Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals |
| Effectiveness of BCG vaccine | 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 |
Countries
Egypt
Contacts
Primary ContactIman Hassan, MD
Backup ContactFatma Soliman E Ebeid
Outcome results
None listed