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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04350931
Recruitment Status : Not yet recruiting
First Posted : April 17, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Adel Khattab, 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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease (COVID-19) Biological: intradermal injection of BCG Vaccine Other: placebo Phase 3

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 PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study.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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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

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




Primary Outcome Measures :
  1. incidence of confirmed COVID-19 [ Time Frame: 9 months ]
    Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals

  2. Effectiveness of BCG vaccine [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350931


Contacts
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Contact: Iman Hassan, MD 01001502179 ext 002 dr.imangalal@gmail.com
Contact: Fatma Soliman E Ebeid 01095569596 ext 002 dr.fatma_ebeid@yahoo.com

Locations
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Egypt
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt, 11566
Contact: Fatma Soliman E Ebeid, MD    01095569596    dr.fatma_ebeid@yahoo.com   
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Adel Khattab, Professor of chest Faculty of Medicine Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT04350931    
Other Study ID Numbers: FMASU P19a/ 2020
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs