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

NCT04350931 | Unknown Phase 3 DMC

• 1 other identifier: FMASU P19a/ 2020
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (2)

• incidence of confirmed COVID-19

  Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals

  9 months

• Effectiveness of BCG vaccine

  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

  9 months

Study Arms (2)

BCG Vaccine

ACTIVE COMPARATOR

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.

Biological: intradermal injection of BCG Vaccine

intradermal normal saline

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

intradermal injection of BCG Vaccine 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

BCG Vaccine

placebo OTHER

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

intradermal normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Non-US, 11566, Egypt

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Iman Hassan, MD

CONTACT

01001502179; dr.imangalal@gmail.com

Fatma Soliman E Ebeid

CONTACT

01095569596; dr.fatma_ebeid@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of chest Faculty of Medicine Ain Shams University

Model Details: 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).

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 17, 2020
• Study Start: April 20, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)