Clinical trial NCT04609774: Aerosol Transmission of Severe Acute Respiratory Syndrome Coronavirus of Coronavirus Disease 2019
Official title: Aerosol Transmission of Severe Acute Respiratory Syndrome Coronavirus: a Dilemma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease (COVID-19)
Keywords: Severe Acute Respiratory Syndrome CoronaVirus 2
Airborne transmission
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient and medical staff at Hospital Italiano de Buenos Aires

Brief summary: There is little information on the characteristics of airborne severe acute respiratory syndrome coronavirus containing aerosols, their concentration, or their infectivity.The aim was to determine airborne severe acute respiratory syndrome coronavirus transmission, their infectivity in different areas such as patient's room and in medical staff área.

Detailed description: The Corona Virus Disease 2019 is rapidly spreading throughout the world. Aerosol is a potential transmission route.

The transmission of severe acute respiratory syndrome coronavirus in humans is thought to be via at least 3 sources: 1) inhalation of liquid droplets produced by and/or 2) close contact with infected persons and 3) contact with surfaces contaminated with severe acute respiratory syndrome coronavirus. There are many respiratory diseases spread by the airborne route such as tuberculosis, measles and chickenpox. Several studies suggested that airborne spread may have played an important role in the transmission of that disease. At present, there is little information on the characteristics of airborne severe acute respiratory syndrome coronavirus containing aerosols, their concentration, or their infectivity.

The aim was to determine airborne severe acute respiratory syndrome coronavirus 2 transmission, their infectivity in in different areas such as patient's room and in medical staff area.

Methods

Cross sectional study of samples from environmental of patient´s room, and medical staff area. Samples will be taken of air using microbial air monitoring systems, and from different surfaces of patient's room and medical staff area, such as computers, mouse and personal protective equipment using cotton swabs. Viral RNA will be determined using Real-Time-Polymerase-Chain Reaction. In positive samples infectiveness will be determined by cell culture under biosecurity conditions.

Statistical analysis will be performed to determine prevalence of positive samples and positive cell culture whit STATA version 15.1.

informed consent will be obtained from all participants

Eligibility criteria: Inclusion Criteria:

* Adults 18 years and more, with diagnoses of COVID-19 96 hours since the beginning of symptoms.
* Medical staff, nurses and/or physician taking care of patient whit COVID-19

Exclusion Criteria:

* Unwilling to give informed consent

Primary outcomes:
measure: Airborne transmission of Severe Acute Respiratory Syndrome CoronaVirus 2
timeFrame: 9 moths
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
References:
citation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
citation: To KK, Tsang OT, Yip CC, Chan KH, Wu TC, Chan JM, Leung WS, Chik TS, Choi CY, Kandamby DH, Lung DC, Tam AR, Poon RW, Fung AY, Hung IF, Cheng VC, Chan JF, Yuen KY. Consistent Detection of 2019 Novel Coronavirus in Saliva. Clin Infect Dis. 2020 Jul 28;71(15):841-843. doi: 10.1093/cid/ciaa149.
citation: Shi F, Yu Q, Huang W, Tan C. 2019 Novel Coronavirus (COVID-19) Pneumonia with Hemoptysis as the Initial Symptom: CT and Clinical Features. Korean J Radiol. 2020 May;21(5):537-540. doi: 10.3348/kjr.2020.0181. Epub 2020 Mar 13.
citation: Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13.
citation: van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
citation: Chin AWH, Chu JTS, Perera MRA, Hui KPY, Yen HL, Chan MCW, Peiris M, Poon LLM. Stability of SARS-CoV-2 in different environmental conditions. Lancet Microbe. 2020 May;1(1):e10. doi: 10.1016/S2666-5247(20)30003-3. Epub 2020 Apr 2. No abstract available.
citation: Liu Y, Ning Z, Chen Y, Guo M, Liu Y, Gali NK, Sun L, Duan Y, Cai J, Westerdahl D, Liu X, Xu K, Ho KF, Kan H, Fu Q, Lan K. Aerodynamic analysis of SARS-CoV-2 in two Wuhan hospitals. Nature. 2020 Jun;582(7813):557-560. doi: 10.1038/s41586-020-2271-3. Epub 2020 Apr 27.
citation: Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0.