Coronavirus Disease (COVID-19)COVID-19NCT04609774
Aerosol Transmission of Severe Acute Respiratory Syndrome Coronavirus of Coronavirus Disease 2019
An observational study of Coronavirus Disease (COVID-19), run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- What is being tested?
- Severe Acute Respiratory Syndrome CoronaVirus 2 detection
- How many people
- 8 participants
- Where
- 1 siteArgentina
- Study dates
- 8 Oct 2020to 1 Dec 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient and medical staff at Hospital Italiano de Buenos Aires
Who may be able to join
- 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
Who cannot join
- Unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerosol Transmission of Severe Acute Respiratory Syndrome Coronavirus: a Dilemma
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.
Read the 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
- Conditions
- Coronavirus Disease (COVID-19)
- Being tested
- Severe Acute Respiratory Syndrome CoronaVirus 2 detection
- Keywords
- Severe Acute Respiratory Syndrome CoronaVirus 2, Airborne transmission
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe Acute Respiratory Syndrome CoronaVirus 2 detectionOther
Severe Acute Respiratory Syndrome CoronaVirus 2 Detection by Real-Time Polymerase Chain Reaction and cell culture
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start8 Oct 2020
- Primary completion20 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VANINA LAURA PAGOTTO, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609774
- Sponsor's protocol ID
- 1345
- Acronym
- COVID-19
- Status last verified
- Feb 2021
- First submitted
- 27 Oct 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31978945To 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.
PubMed 32047895Shi 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.
PubMed 32174057Remuzzi 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.
PubMed 32178769van 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.
PubMed 32182409Chin 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.
PubMed 32835322Liu 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.
PubMed 32340022Guo 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.
PubMed 32169119
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosol Transmission of Severe Acute Respiratory Syndrome Coronavirus: a Dilemma
- ClinicalTrials.gov ID
- NCT04609774
- Acronym / sponsor ID
- COVID-19 / 1345
- Conditions
- Coronavirus Disease (COVID-19)
- Keywords
- Severe Acute Respiratory Syndrome CoronaVirus 2, Airborne transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 30 Oct 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.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient and medical staff at Hospital Italiano de Buenos Aires
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling to give informed consent
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 |
|---|---|---|
| Severe Acute Respiratory Syndrome CoronaVirus 2 detectionSevere Acute Respiratory Syndrome CoronaVirus 2 Detection by Real-Time Polymerase Chain Reaction and cell culture | Other | – |
Primary outcome
Airborne transmission of Severe Acute Respiratory Syndrome CoronaVirus 2
Time frame: 9 moths
Detection of Severe Acute Respiratory Syndrome CoronaVirus 2 RNA by Real Time Polymerase Chain Reaction and cell culture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 31978945Zhu 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.
- Background: PubMed 32047895To 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.
- Background: PubMed 32174057Shi 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.
- Background: PubMed 32178769Remuzzi 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.
- Background: PubMed 32182409van 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.
- Background: PubMed 32835322Chin 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.
- Background: PubMed 32340022Liu 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.
- Background: PubMed 32169119Guo 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease (COVID-19), run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 Feb 2021. 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 Argentina. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airborne transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 (time frame: 9 moths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609774, which also lists 8 linked publications.
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 4 Feb 2021.