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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04609774
Other study ID # 1345
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 8, 2020
Est. completion date December 1, 2020

Study information

Verified date February 2021
Source Hospital Italiano de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date December 1, 2020
Est. primary completion date November 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Severe Acute Respiratory Syndrome CoronaVirus 2 detection
Severe Acute Respiratory Syndrome CoronaVirus 2 Detection by Real-Time Polymerase Chain Reaction and cell culture

Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires Ciudad autónoma de Buenos Aires

Sponsors (1)

Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (8)

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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Airborne transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 Detection of Severe Acute Respiratory Syndrome CoronaVirus 2 RNA by Real Time Polymerase Chain Reaction and cell culture 9 moths
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