Clinical trial NCT04350931: Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19
Official title: Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronavirus Disease (COVID-19)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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 PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study.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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of confirmed COVID-19
timeFrame: 9 months
measure: Effectiveness of BCG vaccine
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
state: Non-US
Study officials:
References: