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

Coronavirus Disease (COVID-19) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04350931
• Other study ID #: FMASU P19a/ 2020
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 20, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2020
• Source: Ain Shams University
• Contact: Iman Hassan, MD
• Phone: 01001502179
• Email: dr.imangalal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Disease (COVID-19)
• Coronavirus Infections

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center	Cairo	Non-US

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of confirmed COVID-19	Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals	9 months
Primary	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