Safety and Usability of the LUMENA Non-invasive Ventilation Mask
Phase: NA
Conditions: Respiratory Failure
Sponsor: Inspir Labs Ltd.



 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 2 of 20 
 
Revision History  
Date 
Revision level 
Change description 
26-Dec-2021 
01 
Initial release 
22-Mar-2022 
02 
Update: Typos corrections, 
addition of groups definitions, 
statistical analysis  
24-July-2022 
03 
Editorial changes of document 
visibility 
Update of sequences of mask 
using times  
01-Jan-2023 
04 
6.1 -Addition of 20 patients to 
recruitment upper limit.; 
9.7 - Removal of Myocardial 
infraction or stroke from exclusion 
criteria 
14.2 – extension of treatment 
duration.  
15.3 - Addition of Tidal volume, 
oxygen saturation, Mode of 
ventilation, peak Inspiratory 
Pressure, Pressure Support, 
Ventilator type and model, Trigger 
sensitivity, Fio2% and PEEP to 
collected data. 
15.4 – elaboration regarding 
historical ECG. 
15.7; 15.8; 15.9; 15.10- rephrasing 
the questions asked during the 
treatment.  
18- update of patient enrollment 
definition.  
 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 3 of 20 
  
  
 
 
 
Study Protocol 
 
Safety and usability of the LUMENA non-invasive ventilation mask 
  
 
 
Primary Investigator: Dr. Nimrod Adi 
Sponsor: InspirLabs, LTD. 
 
Version and date: 4.0 , January 01, 2023 
 
 
Confidentiality Statement 
This protocol contains confidential and proprietary information of Inspir Labs Ltd. (the sponsor). 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 4 of 20 
Any unauthorized use or disclosure of such information without the prior written consent of the 
sponsor is expressly prohibited.  
Contents 
1. 
Study Design.................................................................................................................................................................. 5 
2. 
Background .................................................................................................................................................................... 5 
3. 
Study Objectives .......................................................................................................................................................... 6 
4. 
Sex..................................................................................................................................................................................... 7 
5. 
Ages .................................................................................................................................................................................. 7 
6. 
Number of patients .................................................................................................................................................... 8 
7. 
Statistical analysis ....................................................................................................................................................... 9 
8. 
Inclusion Criteria .......................................................................................................................................................... 9 
9. 
Exclusion Criteria ......................................................................................................................................................... 9 
10. 
Possible device related Adverse Effects ........................................................................................................... 10 
11. 
Special Populations ................................................................................................................................................. 10 
12. 
Study device (Lumena mask) description ........................................................................................................ 11 
13. 
"Lumena"- Specific Components ........................................................................................................................ 13 
14. 
Study Description ..................................................................................................................................................... 14 
15. 
Data Collected ........................................................................................................................................................... 16 
16. 
Risk-Benefit Assessment ........................................................................................................................................ 17 
17. 
Confidentiality and Information Security ........................................................................................................ 18 
18. 
Study Duration .......................................................................................................................................................... 19 
19. 
References .................................................................................................................................................................. 20 
 
 
 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 5 of 20 
1. Study Design: 
A first-in-human, prospective, randomized, non-blinded cross-over study 
 
2. Background: 
The COVID-19 pandemic has taken the lives of millions of persons worldwide and disrupted the 
lives of countless more1. Healthcare workers are considered to be at increased risk of 
contracting SARS-CoV-2, possibly due to increased and prolonged exposure to SARS-CoV-2 
confirmed or suspected individuals2. 
Nosocomial spread of SARS-CoV-2 amongst patients and contagious spread to  HealthCare 
Workers (HCWs) have posed a major challenge and risk for healthcare systems. In Italy, HCWs 
are have paid a heavy price in addition to their professional and humanitarian efforts, with 
21,338 cases (more than 10,4% of total Italian cases and 154 deaths among physicians)3. 
Protecting healthcare workers from nosocomial infection is therefore of paramount importance 
in curbing the spread of the pandemic and in maintaining healthcare systems` capacity. To this 
aim, guidelines for protection of healthcare workers, including the use of Personal Protective 
Equipment (PPE) have been issued by several international4,5. 
SARS-CoV-2 is considered to spread via droplet distribution, however the presence of the virus 
in aerosols has been documented in experimental6 and real-life conditions in crowded, poorly 
ventilated hospital areas unrelated to aerosol generating procedures7. Such infections have 
been reported to be associated with aerosol-generating procedures such as positive pressure 
ventilation8. Several events of nosocomial infection with SARS-CoV-2 following to the use of 
inhalation devices and/or non-invasive ventilation have occurred in the Tel Aviv Sourasky 
Medical Center (TASMC) [Internal TASMC data].  

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 6 of 20 
Patients presenting to the emergency department, or needing hospitalization, for a variety of 
medical conditions often require Non-Invasive Ventilation (NIV). These patients` condition often 
requires close and continuous support by a staff member, putting these staff members at 
increased exposure to respiratory aerosols which could possibly contain SARS-CoV-2 of other 
airborne pathogens. 
The “Lumena” mask is a disposable, single-patient, adult Oro-nasal mask, intended to provide a 
patient interface for transmission of NIV while minimizing dispersion of bio-aerosols from and 
into the breathing surrounding. It makes use of a dual layered containment space being 
constantly depressurized into a filtration system, thus allowing safety of use with non-
hermetically sealed devices.  
The mask has been approved by the Israeli Ministry of Health ("AMAR" / אמ"ר) as a medical 
device based on its intrinsic properties. This mask has undergone pre-clinical testing and is 
approved for marketing in several authorities. Inspir Labs, the sponsor is ISO 13485 certified.  
The purpose of this study is to evaluate the safety, usability and effectiveness of the Lumena 
mask and its ability to prevent  the spread of respiratory aerosols in a real-world clinical setting. 
 
3. Study Objectives: 
3.1. Primary objective:  
To assess the safety of the Lumena mask, compared to commercially available, commonly 
used oro-nasal face masks. 
3.2. Secondary objectives: 
3.2.1. To assess the effectiveness of the Lumena mask in achieving pre-defined clinical 
endpoints (i.e. oxygenation and ventilation), compared to commercially available, 
commonly used oro-nasal face masks. 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 7 of 20 
3.2.2. To assess the effectiveness of the Lumena mask in reducing the spread of 
respiratory aerosol in the patient's environment, compared to commercially 
available, commonly used Oro-nasal face masks. 
3.2.3. To assess patient comfort and satisfaction while using the Lumena mask, 
compared to commercially available, commonly used Oro-nasal face masks. 
3.2.4. To assess staff ease of use and overall satisfaction with using the Lumena mask, 
compared to commercially available, commonly used Oro-nasal masks. 
3.2.5. To assess the effectiveness of the Lumena mask in prevention of spread of 
respiratory particles during positive-pressure non-invasive ventilation within the 
Intensive Care Unit. 
 
4. Sex: 
Study will include both females and males, with at least 20% of patients beeing females. 
 
5. Ages: 
18 years and over 
 
 
 
 
 
 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 8 of 20 
6. Number of patients: 
6.1. 40 patients will be included in the study, until reaching 5 patients for each group. 
Patients who drop out of the study for any reason will be replaced. 
6.2. The study will be designed to contain 4 groups, each containing 5 patients.   
6.3. The trial is designed as a crossover trial, as all patients will be required to use both 
Lumena mask and the control mask. The order of interventions is determined by the 
designated group. Prior to every inhalation and particle sampling, a baseline sample will 
be taken to filter possible carryovers from previous sampling. 
Table 1 - Crossover Groups & Periods 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Group 
Period 1 
Period 2 
Period 3 
A 
Standard 
Lumena No 
Suction 
Lumena Suction 
B 
Standard 
Lumena Suction 
Lumena No 
Suction 
C 
Lumena No 
Suction 
Lumena Suction 
Standard 
D 
Lumena Suction 
Lumena No 
Suction 
Standard 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 9 of 20 
7. Statistical analysis: 
Statistical analysis will be conducted following conclusion of the trial. A pre-test for the 
assumption of negligible carryover will be conducted as specified below:  
 
After which a test for differences between treatment effects will be carried, according to the 
same formula but applying it to within-subject differences9 
 
8. Inclusion Criteria: 
8.1. Adults males and females  aged 18 years and over. 
8.2. Suffering from hypoxemic and/or hypercarbic respiratory failure requiring non-invasive 
ventilation and selected by medical staff to use CPAP or BiPAP. 
8.3. Fully conscious (Glasgow Coma Scale 14-15) and able to cooperate with non-invasive 
ventilation. 
8.4. Able to provide informed consent to participate in the study. 
8.5. Have an active arterial line in place for arterial blood sampling (arterial lines will not be 
placed for the sole purpose of the study). Alternatively, IV line can be used. 
 
9. Exclusion Criteria: 
9.1. Age < 18 years. 
9.2. Pregnancy. 
9.3. Respiratory failure due to non-pulmonary pathology. 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 10 of 20 
9.4. Presence of a contraindication to the use of non-invasive ventilation or an absolute 
indication for invasive ventilation. 
9.5. Presence of a facial deformity, heavy beard or moustache which prevents a good seal 
between the mask and the face. 
9.6. Hemodynamic instability. 
9.7. Severe upper gastrointestinal bleeding. 
9.8. Chest trauma. 
9.9. Claustrophobia 
 
10. Possible device related Adverse Effects: 
10.1. Device-Specific AE’s: 
10.1.1.  Impaired patient ventilator synchrony 
10.2. Non Device-Specific possible AE’s include: 
10.2.1. Barotrauma 
10.2.2. Nausea 
10.2.3. Feeling of claustrophobia 
10.2.4. Facial and eye irritation 
10.2.5. Facial pain due to pressure 
 
11. Special Populations: 
The study will not include special populations such as pregnant women, persons who are not 
able to provide informed consent or those under 18 years of age. 
 
 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 11 of 20 
12. Study device (Lumena mask) description: 
 
Figure 1: Lumena Mask 
The Disposable Single-Patient-Use “Lumena” Oro-Nasal mask is a transparent mask for 
administration of non invasive ventilation (NIV) designed to minimize aerosolization into the 
surrounding environment. Each mask may be used for up to 14 days. 
The mask is an interface accessory for use with a positive pressure ventilation device such as a 
BiPAP/CPAP machines or a mechanical ventilator. All of the mask components are able to be 
cleaned. 
The face piece consists of an internal volume for providing patient ventilation by a positive 
pressure, “covered” with an external layer kept at a sub-atmospheric pressure by a suction 
source (either a dedicated vacuum generator or a hospital wall suction) in order to continuously 
capture any air escaping from the internal volume. A circumferential sealing cushion is 
positioned between the internal volume and the external layer to minimize any escape of 
potentially contaminated air into the external layer. The Mounting Head Gear has straps that 
are adjustable and hold the Face Piece against the patient’s face while slightly squeezing the 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 12 of 20 
aforementioned sealing cushion, thus minimizing any potential gas leakage from the internal 
volume. 
The “Lumena” is a non-vented mask that does not incorporate an integrated CO2 exhaust vent 
in its design, and as such must be used only as part of a dual limb circuit or a single limb circuit 
that contains auxiliary CO2 exhaust features. The mask is designed to be used in positive 
pressures ranging from  4-30 cmH2O. 
The mask is connected via a standard suction tube to a vacuum source that can provide at least 
30 liter/minute of flow as a safe, aerosol minimizing device, but can also be used as a regular, 
non-safe NIV mask when it is not connected to a vacuum source. The mask contains two 
separate spaces, an inner space positively pressurized to administer positive pressure 
ventilation, and a separate, negatively pressurized space that scavenges aerosol emitted during 
ventilation and prevents it from being released into the surrounding environment. 
The mask has been approved by the Israeli Ministry of Health`s Medical Devices Department 
("AMAR"/אמ"ר), approval #34860001. 
 
 
 
 
 
 
 
 
 
 
Figure 2: Lumena gap Pathway 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 13 of 20 
13. "Lumena"- Specific Components: 
 
 
 
 
 
 
 
 
 
The mask, which is available in 3 sizes (Small, Medium, Large), consists of the following basic 
components: 
1. 
Mask Frame, containing: 
a. 
Suction port for connection to a vacuum source, either wall suction or a portable 
vacuum machine using via a 28Fr suction tube in order to maintain negative pressure in the 
mask’s outer layer 
2. 
Clip On 
3. 
Quick-Release Clip 
4. 
Elbow 
5. 
Oxygen Port Cap 
6. 
Suction & Inlet Tubes Gripper (*2 in kit) 
7. 
Swivel lock Ring 
8. 
Head Cushion 
9. 
Inner Cushion 
10. 
Outer Cushion 
11. 
Headgear Strap 
12. 
O-Ring 
13. 
Suction Cap 
14. 
Silicone Guard 
 
 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 14 of 20 
14. Study Description: 
14.1. Enrollment phase: 
All patients at the relevant departments who require non-invasive mechanical 
ventilation according to treating physician's decision will be screened for eligibility, 
given an investigator is available. Study eligibility will be determined by the inclusion 
and exclusion criteria. All eligible patients who meet study eligibility will be  offered to 
participate in the study. Signed informed consent will be performed by research staff.  
The offer to enroll shall be presented only by the investigators and will be presented to 
all eligible patients. 
 Consented patients will be randomized to one of four groups. Each group has a unique 
sequence protocol: 
A. 1) Standard NIV mask [30-60 minutes]; 2) Lumena mask without suction [30-60 
minutes ]; 3) Lumena mask with suction [30-60 minutes]. 
B. 1) Standard NIV mask [30-60 minutes]; 2) Lumena mask with suction [30-60 
minutes]; 3) Lumena mask without suction [30-60 minutes]. 
C. 1) Lumena mask without suction [30-60 minutes]; 2) Lumena mask with suction [30-
60 minutes]; 3) Standard NIV mask [30-60 minutes]. 
D. 1) Lumena mask with suction [30-60 minutes]; 2) Lumena mask without suction [30-
60 minutes]; 3) Standard NIV mask [30-60 minutes]. 
Data required for study purposes (see below) will be collected at time of enrollment 
from the medical record and/or from direct questioning of the study patient. 
 
 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 15 of 20 
14.2. Intervention phase: 
Following randomization, each patient will be placed on BIPAP or a CPAP (per clinical 
need) using either the aerosol-reducing mask (Lumena) for approximately 1-2 hours, 
and then on the standard NIV mask used at the department for another 1-2 hours, or 
vice versa according to randomization scheme. In general, ventilation at each condition 
will be 30-60 minutes for each condition, with variation expected due to patient clinical 
need. Suction will be connected/disconnected from the Lumena mask according to the 
randomization schemes 30-60 minutes from placement of the mask. The patients will 
serve as their own control (cross over design). 
During each of the three study phases (use of standard NIV mask, use of Lumina mask 
with suction and use of Lumina mask without suction), an inhalation of 5 ml 0.9% NaCl 
will be administered to the patient via the mask (using an in-line connector and a 
standard inhalation chamber) to enhance potential for environmental spread of small 
particles and thus enhance the ability to discriminate between the standard mask and 
the Lumina masks` ability to minimize aerosol spread.  
Eligible patients will be enrolled into the study, perform trial activities and exit the study 
within a maximum of 1 day.  
The study will be performed in a hospital intensive-care setting due to the nature of the 
device, and the required patients population. 
 
 
 
 
 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 16 of 20 
14.3. Monitoring: 
During all phases of the study (either using standard NIV mask or Lumina mask), a staff 
member will be present in the patient's room.  
Vital signs during NIV will be recorded in real time by the staff member. 
Before, during and after NIV, and electrocardiogram (ECG) will be monitored and 
arterial blood\ venous gas (ABG\VBG) samples will be drawn. 
A particle-measuring device (Particle Plus 8303) will be placed at a distance of 1.5 meter 
from the patient`s face to record the level of aerosol spread. 
Following each session of NIV, the patient as well as the staff member treating the 
patient will be asked to complete a short questionnaire regarding the comfort and ease 
of use of each of the masks used. Any adverse events will be captured in real time by 
the staff member. 
 
15. Data Collected: 
15.1. Demographics including as age, sex, DOB, height, weight and body mass index. 
15.2. Past medical history including smoking status, co-morbid conditions and medication 
use. 
15.3. Vital signs before, during and after non-invasive ventilation such as: heart rate, 
respiratory rate, Tidal volume, oxygen saturation, Mode of ventilation, peak Inspiratory 
Pressure, Pressure Support, Ventilator type and model, Trigger sensitivity,Fio2%, PEEP, 
blood pressure (invasive and/or non-invasive),  and temperature. 
15.4. Electrocardiogram (ECG) diagrams before use (historical ECG can be also use)  and 
monitoring during use. 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
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15.5. Arterial blood\ Venous blood gas analysis for O2, CO2, pH and HCO3 as well as serum 
Lactate levels before, during and after non-invasive ventilation. A maximum of 20 ml of 
blood will be collected from each patient.  
15.6. Symptoms and signs during use of non-invasive ventilation (e.g. diaphoresis, anxiety). 
15.7. Estimation of patient preference of the mask-  The question shall be phrased thusly: 
which mask do you prefer?  
15.8. Estimation of staff comfort (an analog 1-5 scale as well as recording of verbal 
comments) – the question shall be phrased thusly: In a scale of 1-5, 1 being very 
uncomfortable and 5 being very comfortable, how would you rate the mask? 
15.9. Estimation of staff use - The question shall be phrased thusly: which mask do you 
prefer?  
15.10. Estimation of patient comfort – the question will be directed to the staff member. (an 
analog 1-5 scale as well as recording of verbal comments). – the question shall be 
phrased thusly: In a scale of 1-5, 1 being very uncomfortable and 5 being very 
comfortable ,how would you rate the patient's feeling with the experimental mask? 
15.11. Device related adverse events will be reported by number, type, seriousness, severity 
, duration and attribution . All device and treatment related adverse events will be 
captured, regardless of severity. 
 
16. Risk-Benefit Assessment  
This is a feasibility proof of concept study, i.e. the nature and purpose of this study is to collect 
data to support research and development of the Lumena mask during noninvasive ventilation. 
The patients will have no direct health benefit from the use of the device. 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
Page 18 of 20 
Expected benefit for patients and staff will arise from the future creation a safer care 
environment, potentially minimizing the need for bulky personal protective equipment (PPE).  
The Lumena mask is considered class II device in Europe. Risk assessment has been performed 
and no major or intolerable risks were found. All the mitigations were documented. The risk 
management summary in the company’s IB demonstrates that the risks associated with the 
tested devices are well mitigated and are as low as reasonably practicable as defined by the 
applicable standards. 
As for the Lumena mask usage, the protocol has been designed to decrease and minimize the 
risk to the patients by monitoring the respiratory parameters and using it for no more than an 
hour.  
Expected adverse events like cough or bronchospasm may arise during inhalation study. 
Subjects will be monitored closely for safety and reporting of adverse events during the study 
including follow up until complete resolution of any adverse events. 
 
17. Confidentiality and Information Security 
Each patient will be assigned a unique identifying number and that number will be used 
throughout all data collection and analysis processes. 
The mapping of study identifiers and patient details will be stored by the primary investigator in 
a locked cabinet or a password-protected hospital-issued computer. The mapping list will be 
deleted or physically destroyed after completion of data analysis, and a report of said deletion 
will be included in the study summary. This file will not be sent via unencrypted email nor will it 
be removed from hospital premises without written consent by the hospital’s R&D division. 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
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Only the primary and secondary investigators, who are hospital employees with permission to 
access medical records, will have access to the de-identified data. Specifically, the sponsor will 
not have access to de-identified patient data. 
 
 
18. Study Duration: 
18 months or until enrollment of 40 eligible patients (the first of both occurrences). 
Each patient will be included for a maximum of one day, from enrollment and obtainment of 
informed consent until end of participation. 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
Date 1st Issued: 
26.12.2021 
Title: 
Clinical trials protocol – “Lumena”; 
Safety and usability of the LUMENA non-invasive 
ventilation mask 
Doc #: CL-003 
Revision: 04 
Confidential 
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19. References: 
1. 
Hannah Ritchie, Edouard Mathieu, Lucas Rodés-Guirao, Cameron Appel, Charlie Giattino, Esteban Ortiz-
Ospina, Joe Hasell, Bobbie Macdonald, Diana Beltekian and Max Roser (2020) - "Coronavirus Pandemic 
(COVID-19)". Published online at OurWorldInData.org. Retrieved from: 
'https://ourworldindata.org/coronavirus' [Online Resource] 
2. 
Sergio Alejandro Gómez-Ochoa, Oscar H Franco, Lyda Z Rojas, Peter Francis Raguindin, Zayne Milena Roa-
Díaz, Beatrice Minder Wyssmann, Sandra Lucrecia Romero Guevara, Luis Eduardo Echeverría, Marija Glisic, 
Taulant Muka, COVID-19 in Health-Care Workers: A Living Systematic Review and Meta-Analysis of 
Prevalence, Risk Factors, Clinical Characteristics, and Outcomes, American Journal of Epidemiology, Volume 
190, Issue 1, January 2021, Pages 161–175, https://doi.org/10.1093/aje/kwaa191 
3. 
Iannone P, Castellini G, Coclite D, et al. The need of health policy perspective to protect Healthcare Workers 
during COVID-19 pandemic. A GRADE rapid review on the N95 respirators effectiveness. PLoS One. 
2020;15(6):e0234025. Published 2020 Jun 3. doi:10.1371/journal.pone.0234025 
4. 
Center for Disease Control. Interim Infection Prevention and Control Recommendations for Healthcare 
Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic. 
https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html 
5. 
WHO. Personal protective equipment for COVID-19. https://www.who.int/teams/health-product-policy-and-
standards/assistive-and-medical-technology/medical-devices/ppe/ppe-covid 
6. 
Iannone P, Castellini G, Coclite D, et al. The need of health policy perspective to protect Healthcare Workers 
during COVID-19 pandemic. A GRADE rapid review on the N95 respirators effectiveness. PLoS One. 
2020;15(6):e0234025. Published 2020 Jun 3. doi:10.1371/journal.pone.0234025 
7. 
Joshua L Santarpia, DNR, Vicki Herrera M. Jane Morwitzer, Hannah Creager, George W. Santarpia, et al. 
Transmission Potential of SARS-CoV-2 in Viral Shedding Observed at the University of Nebraska Medical 
Center. 2020. 
8. 
Dobler CC, Murad MH, Wilson ME. Noninvasive Positive Pressure Ventilation in Patients With COVID-
19. Mayo Clin Proc. 2020;95(12):2594-2601. doi:10.1016/j.mayocp.2020.10.001 
9. 
Wellek, S., & Blettner, M. (2012). On the proper use of the crossover design in clinical trials: part 18 of a series 
on evaluation of scientific publications. Deutsches Arzteblatt international, 109(15), 276–281. 
https://doi.org/10.3238/arztebl.2012.0276