Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19

Phase 3

• Conditions: Coronavirus Disease (COVID-19)
• Interventions: Biological: intradermal injection of BCG Vaccine; Other: placebo

• Registration Number: NCT04350931
• Lead Sponsor: Ain Shams University

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 PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study.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

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Last Update Submitted: 2020-04-17
• Study Start: 2020-04-20
• Last Update Posted: 2020-04-20
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Healthy healthcare workers defined as nurses and physicians working at emergency rooms, ICUs, and wards of isolation hospitals

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCG Vaccine	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 (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.
intradermal normal saline	placebo	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center; 🇪🇬 Cairo, Non-US, Egypt