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

Last updated: April 17, 2020
Sponsor: Ain Shams University
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04350931
FMASU P19a/ 2020
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Immunosuppression

  • Pregnancy & lactation

  • Chronic underlying medical illness

  • Known allergy to (components of) the BCG vaccine or serious adverse events to priorBCG administration

  • Known active or latent Mycobacterium tuberculosis or with another mycobacterialspecies.

  • Fever (>38 C) within the past 24 hours

  • Current bacterial infection

  • Recent viral infection

  • Refusal of doing tuberculin test in the first group

Study Design

Total Participants: 900
Study Start date:
April 20, 2020
Estimated Completion Date:
December 01, 2020

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 PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study.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

Connect with a study center

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

    Cairo, Non-US 11566
    Egypt

    Site Not Available

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