Coronavirus Disease (COVID-19)Phase 3NCT04350931
Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19
A Phase 3 study testing intradermal injection of BCG Vaccine in people with Coronavirus Disease (COVID-19), run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- What is being tested?
- intradermal injection of BCG Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2020to 1 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy healthcare workers defined as nurses and physicians working at emergency rooms, ICUs, and wards of isolation hospitals
Who cannot join
- 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
Show all 9Show fewer
- Current bacterial infection
- Recent viral infection
- Refusal of doing tuberculin test in the first group
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566
Fatma Soliman E Ebeid, MD, 01095569596, dr.fatma_ebeid@yahoo.com
About this study
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.
Read the detailed description
Nine hundred healthcare workers will be randomly assigned to receive intradermal injection of either BCG vaccine or normal saline.
During the study:
- 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.
- Participants will be assessed clinically on daily basis for COVID 19 infection in the form of: fever, dry cough, fatigue, \& dyspnea.
- PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study.
- 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)
- Being tested
- intradermal injection of BCG Vaccine, placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradermal injection of BCG VaccineBiological
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
placeboOther
placebo 0.10 mL intradermal normal saline (0.9% NaCl) over the distal insertion of the deltoid muscle onto the humerus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of confirmed COVID-19
Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start20 Apr 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Khattab, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350931
- Sponsor's protocol ID
- FMASU P19a/ 2020
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19
- ClinicalTrials.gov ID
- NCT04350931
- Acronym / sponsor ID
- FMASU P19a/ 2020
- Conditions
- Coronavirus Disease (COVID-19)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Participants will be assessed clinically on daily basis for COVID 19 infection in the form of: fever, dry cough, fatigue, \& dyspnea.
- PCR sampling for COVID-19 will be withdrawn for all participants at the end of the study.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| BCG Vaccine | Active comparator | Biological: intradermal injection of BCG Vaccine0.10 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. |
| intradermal normal saline | Placebo comparator | Other: placeboplacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy healthcare workers defined as nurses and physicians working at emergency rooms, ICUs, and wards of isolation hospitals
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intradermal injection of BCG Vaccine0.10 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 | Biological | BCG Vaccine |
| placeboplacebo 0.10 mL intradermal normal saline (0.9% NaCl) over the distal insertion of the deltoid muscle onto the humerus | Other | intradermal normal saline |
Primary outcome
incidence of confirmed COVID-19
Time frame: 9 months
Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intradermal injection of BCG Vaccine in people with Coronavirus Disease (COVID-19), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iman Hassan, MD (01001502179 ext. 002, dr.imangalal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of confirmed COVID-19 (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.