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.
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 PCR sampling for COVID-19 will be withdrawn for all participants at the end of the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.
Biological: intradermal 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
Other: placebo
placebo 0.10 mL intradermal normal saline (0.9% NaCl) over the distal insertion of the deltoid muscle onto the humerus
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
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt
Investigator: Fatma Soliman E Ebeid, MD
Contact: 01095569596
dr.fatma_ebeid@yahoo.com
Iman Hassan, MD
01001502179 - 002
dr.imangalal@gmail.com
Fatma Soliman E Ebeid
01095569596 - 002
dr.fatma_ebeid@yahoo.com