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

NCT ID: NCT04350931

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-20
• Study Completion Date: 2020-12-01

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 PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study.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

Conditions

Coronavirus Disease (COVID-19)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

intradermal injection of BCG Vaccine

Intervention Type: BIOLOGICAL

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

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo 0.10 mL intradermal normal saline (0.9% NaCl) over the distal insertion of the deltoid muscle onto the humerus

Interventions

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

Intervention Type: BIOLOGICAL

placebo

placebo 0.10 mL intradermal normal saline (0.9% NaCl) over the distal insertion of the deltoid muscle onto the humerus

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Adel Khattab

Professor of chest Faculty of Medicine Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, Egypt

Countries

Egypt

Central Contacts

Iman Hassan, MD

Role: CONTACT

dr.imangalal@gmail.com

01001502179 ext. 002

Fatma Soliman E Ebeid

Role: CONTACT

dr.fatma_ebeid@yahoo.com

01095569596 ext. 002

Facility Contacts

Fatma Soliman E Ebeid, MD

Role: primary

dr.fatma_ebeid@yahoo.com

01095569596

Other Identifiers

FMASU P19a/ 2020

Identifier Type: -

Identifier Source: org_study_id