FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing ~1x10^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (~2x10^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area.

A single dose will consist of 0.1 mL saline

Coronavirus

Coronavirus Infection

Coronavirus as the Cause of Diseases Classified Elsewhere

BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.

BCG Vaccine

Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.

Placebo Vaccine

Cedars-Sinai Medical Center

Texas A&M Family Care Clinic

Baylor College of Medicine

Baylor St. Luke's Medical Center

Harris Health System - Ben Taub Hospital

MD Anderson Cancer Center

BCG Vaccine for Health Care Workers as Defense Against COVID 19

Bacillus Calmette-Guerin Vaccination as Defense Against SARS-CoV-2: A Randomized Controlled Trial to Protect Health Care Workers by Enhanced Trained Immune Responses

The primary outcome measure is the development of COVID19 infection. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of Covid-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert. defined as number of new cases during the 6 month time period

The secondary outcome measure is disease severity calculated using the Covid Severity Scale Scoring of 0 -10. A score of 10 is worse and a score of 0 is best. Disease severity score will be based on the level of care required for individuals who test positive for COVID19 as follows: non-hospital-based care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died. Additional WHO criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis and septic shock.

There is not a plan to make IPD available.

Andrew Dinardo

Principal Investigator / Assistant Professor

Texas A&M University

M.D. Anderson Cancer Center

Harvard University

Participants will be randomized to BCG:placebo in a 1:1 ratio.

Randomization will be done centrally and computer generated with stratification per hospital in random blocks of 2, 4 and 6. The BCG vaccine will be administered by research nurses. Participants and investigators will be blinded. The research nurse that administers the BCG vaccine or placebo will not be blinded. This research nurse will not be involved in the collection of outcome data.

For every enrolled H1N1 case, the study will enroll 2 sex matched controls. On the date of enrollment of a case, 2 sex-matched controls will be located from the same clinic from which the case was enrolled. Enrolled controls will then be verified to be free from influenza infection at the time of enrollment by RT-PCR.

A swab will be collected from cases to verify presence of pandemic influenza. Testing positive for influenza A/H1N1 by RT PCR to be enrolled will be confirmed as a case. The participant will be presented with a questionnaire that will capture exposure data through a group of variables assessing underlying health conditions, symptoms, use of influenza vaccine, travel, occupational setting, and other demographic variables. Cases will be contacted once during the study.

Specimens collected from cases(ie positive for pandemic influenza by RT PCR) will be processed in order to isolate and characterize the viruses causing infection.

A/H1N1 Influenza

Swine Flu

American University of Beirut

Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon

This study hypothesize that certain factors make people more vulnerable to be infected with A/H1N1, such as traveling to H1N1 infected area, exposure to infected patients, no influenza vaccination, residency in nursing homes, attendance of daycares, poor health and etc.

Through these techniques, the study will isolate and characterize influenza viruses causing infection and morbidity severity of infection among the enrolled cases.

This study hypothesizes that certain factors make patients infected with A/H1N1 more vulnerable to severe illness or death, such as obesity, pregnancy, tobacco use, and other co-morbidities (pulmonary diseases, cardiovascular diseases, diabetes, and renal insufficiency).

St. Jude Children's Research Hospital

American University of Beirut Medical Center

Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.

Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.

A Standard endotracheal tube will be inserted in case both other airway devices (LMA Supreme and iGel) devices fail to provide adequate ventilation.

Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.

I-Gel

Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.

LMA Supreme

Total

Sex: Female, Male

Weight

Height

Measure of the Airway Leak Pressure

Measure of the Peak Airway Pressure

Time Needed to Secure the Airway

Number of Participants With Successful Attempts to Introduce the Devices

Intent to treat assessment of adverse events, per intervention, was intended. The adverse effects were assessed by phone; or in person if patient in the hospital; on the following day.

Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)

Airway Manipulation and Blood on Device at Removal

Overall Study

Nikola Joly, M.D.

Anesthesia Airway Management

2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA.

I-Gel supraglottic airway device

In the LMA Supreme group, the same interventions will be done as in the I-Gel group. The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Leak pressure will also be measure at 45 mL. Once the leak test is done, the cuff will be deflated to initial volume necessary to avoid audible leaks.

LMA Supreme supraglottic airway device

In case both supraglottic airway devices fail, a standard endotracheal tube will be inserted

pharyngitis/nikotin

BCG Vaccine for Health Care Workers as Defense Against COVID 19

Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon

Comparison Study of Two Supraglottic Airway Devices Used for Patients Under General Anesthesia

A Comparison of Bupropion SR and Placebo for Smoking Cessation

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