SARS-CoV-2 VirusNCT06027398
SARS-COV-2 Detection From Used Surgical Mask
A study testing SARS-CoV-2 RNA detection in people with SARS-CoV-2 Virus, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
Trial summary
The real-time reverse transcription-polymerase chain reaction (RT-PCR) test is regarded as the gold standard for SARS-CoV-2 detection. Proper specimen collection and obtaining a sufficient sample are the most important steps for laboratory diagnosis. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- SARS-CoV-2 Virus
- What is being tested?
- SARS-CoV-2 RNA detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2021to 30 Sep 2021
- Phase
- Interventional
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly confirmed SARS-CoV-2 positive cases admitted to a field hospital within 48 hours or outpatient with a positive result for SARS-CoV-2
- Should be able to wear a mask for 8 h according to the protocol
Who cannot join
- require oxygen intubation or any breathing support devices
Trial locations and contacts
1 site in 1 country.
Thailand1 site
2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand
Bangkok, 10400
About this study
Official title: Efficacy of SARS-COV-2 Detection From Used Surgical Mask Compared to Standard Detection Method
The real-time reverse transcription-polymerase chain reaction (RT-PCR) test is regarded as the gold standard for SARS-CoV-2 detection. Proper specimen collection and obtaining a sufficient sample are the most important steps for laboratory diagnosis. The nasopharyngeal (NP) swab is recommended as the reference collection method. However, NP swab collection is invasive and uncomfortable for patients and poses some risk to healthcare workers. This study aimed to compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with the NP swab method using RT-PCR testing
Read the detailed description
Proper specimen collection and obtaining sufficient samples are the most important steps for laboratory diagnosis of an infectious disease. Improper collection may lead to false or inconclusive test results. During the early stages of the COVID-19 outbreak, the Center for Disease Prevention and Control recommended collecting and testing an upper respiratory specimen [4]. Nasopharyngeal (NP) and oropharyngeal (OP) swabs are the preferred choice for initial SARS-CoV-2 diagnostic testing.
This study aimed to compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods. We tested for SARS-CoV-2 RNA in masks from patients with COVID-19 that had been worn for eight hours and compared this with NP swabs using RT-PCR testing. Hospitalized patients with laboratory-confirmed COVID-19 were recruited to provide surgical masks. Collection of used surgical mask samples by patients themselves is easy, convenient, requires no sampling equipment and decreases the risk of healthcare personnel exposure to COVID-19. If SARS-CoV-2 RNA can be detected on used surgical mask samples, this may encourage patients to provide specimens for testing and help in early detection and transmission prevention. As an alternative method to NP swabs, it may facilitate timely diagnosis and treatment.
- Conditions
- SARS-CoV-2 Virus
- Being tested
- SARS-CoV-2 RNA detection
- Keywords
- Nasopharyngeal swab, RT-PCR, SARS-CoV-2, surgical mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 RNA detectionDiagnostic test
SARS-CoV-2 RNA detection in used mask filters
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 RNA in masks | Experimental | . After the participants had worn the masks for 8 h, the nurse collected the filters and placed each into a viral transport medium (VTM) tube This was placed inside a clean plastic bag, sprayed with alcohol, placed in an icebox and sent to the biomolecular laboratory for real-time RT-PCR SARS-CoV-2 testing. Receives: Diagnostic Test: SARS-CoV-2 RNA detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy of SARS-CoV-2 RNA detection from used surgical masks
tested for SARS-CoV-2 RNA in masks from patients with COVID-19 that had been worn for eight hours and compared this with NP swabs using RT-PCR testing
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 May 2021
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 VirusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods
- Masking
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Investigators
- Thananda Trakarnvanich, M.D., Principal investigator, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027398
- Sponsor's protocol ID
- 138/64
- Status last verified
- Nov 2024
- First submitted
- 31 Aug 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data underlying this article are available in figshare 10.6084/m9.figshare.24064218
Publications
Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3.
PubMed 32015508Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, Li Y, Zhu L, Wang N, Lv Z, Gao H, Ge X, Kan B, Hu Y, Liu J, Cai F, Jiang D, Yin Y, Qin C, Li J, Gong X, Lou X, Shi W, Wu D, Zhang H, Zhu L, Deng W, Li Y, Lu J, Li C, Wang X, Yin W, Zhang Y, Qin C. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020 Jul 3;369(6499):77-81. doi: 10.1126/science.abc1932. Epub 2020 May 6.
PubMed 32376603Qian Y, Zeng T, Wang H, Xu M, Chen J, Hu N, Chen D, Liu Y. Safety management of nasopharyngeal specimen collection from suspected cases of coronavirus disease 2019. Int J Nurs Sci. 2020 Apr 4;7(2):153-156. doi: 10.1016/j.ijnss.2020.03.012. eCollection 2020 Apr 10.
PubMed 32292635Comber L, Walsh KA, Jordan K, O'Brien KK, Clyne B, Teljeur C, Drummond L, Carty PG, De Gascun CF, Smith SM, Harrington P, Ryan M, O'Neill M. Alternative clinical specimens for the detection of SARS-CoV-2: A rapid review. Rev Med Virol. 2021 Jul;31(4):e2185. doi: 10.1002/rmv.2185. Epub 2020 Oct 22.
PubMed 33091200
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of SARS-COV-2 Detection From Used Surgical Mask Compared to Standard Detection Method
- ClinicalTrials.gov ID
- NCT06027398
- Acronym / sponsor ID
- 138/64
- Conditions
- SARS-CoV-2 Virus
- Keywords
- Nasopharyngeal swab, RT-PCR, SARS-CoV-2, surgical mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 7 Sep 2023 (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.
The real-time reverse transcription-polymerase chain reaction (RT-PCR) test is regarded as the gold standard for SARS-CoV-2 detection. Proper specimen collection and obtaining a sufficient sample are the most important steps for laboratory diagnosis. The nasopharyngeal (NP) swab is recommended as the reference collection method. However, NP swab collection is invasive and uncomfortable for patients and poses some risk to healthcare workers. This study aimed to compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with the NP swab method using RT-PCR testing
Detailed description
Proper specimen collection and obtaining sufficient samples are the most important steps for laboratory diagnosis of an infectious disease. Improper collection may lead to false or inconclusive test results. During the early stages of the COVID-19 outbreak, the Center for Disease Prevention and Control recommended collecting and testing an upper respiratory specimen [4]. Nasopharyngeal (NP) and oropharyngeal (OP) swabs are the preferred choice for initial SARS-CoV-2 diagnostic testing.
This study aimed to compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods. We tested for SARS-CoV-2 RNA in masks from patients with COVID-19 that had been worn for eight hours and compared this with NP swabs using RT-PCR testing. Hospitalized patients with laboratory-confirmed COVID-19 were recruited to provide surgical masks. Collection of used surgical mask samples by patients themselves is easy, convenient, requires no sampling equipment and decreases the risk of healthcare personnel exposure to COVID-19. If SARS-CoV-2 RNA can be detected on used surgical mask samples, this may encourage patients to provide specimens for testing and help in early detection and transmission prevention. As an alternative method to NP swabs, it may facilitate timely diagnosis and treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 RNA in masks | Experimental | Diagnostic Test: SARS-CoV-2 RNA detection. After the participants had worn the masks for 8 h, the nurse collected the filters and placed each into a viral transport medium (VTM) tube This was placed inside a clean plastic bag, sprayed with alcohol, placed in an icebox and sent to the biomolecular laboratory for real-time RT-PCR SARS-CoV-2 testing. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Newly confirmed SARS-CoV-2 positive cases admitted to a field hospital within 48 hours or outpatient with a positive result for SARS-CoV-2
- Should be able to wear a mask for 8 h according to the protocol
Key exclusion criteria (1 listed)
- require oxygen intubation or any breathing support devices
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 |
|---|---|---|
| SARS-CoV-2 RNA detectionSARS-CoV-2 RNA detection in used mask filters | Diagnostic test | SARS-CoV-2 RNA in masks |
Primary outcome
the efficacy of SARS-CoV-2 RNA detection from used surgical masks
Time frame: 3 months
tested for SARS-CoV-2 RNA in masks from patients with COVID-19 that had been worn for eight hours and compared this with NP swabs using RT-PCR testing
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 15 Nov 2024.
- Results publication: PubMed 32015508Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3.
- Results publication: PubMed 32376603Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, Li Y, Zhu L, Wang N, Lv Z, Gao H, Ge X, Kan B, Hu Y, Liu J, Cai F, Jiang D, Yin Y, Qin C, Li J, Gong X, Lou X, Shi W, Wu D, Zhang H, Zhu L, Deng W, Li Y, Lu J, Li C, Wang X, Yin W, Zhang Y, Qin C. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020 Jul 3;369(6499):77-81. doi: 10.1126/science.abc1932. Epub 2020 May 6.
- Results publication: PubMed 32292635Qian Y, Zeng T, Wang H, Xu M, Chen J, Hu N, Chen D, Liu Y. Safety management of nasopharyngeal specimen collection from suspected cases of coronavirus disease 2019. Int J Nurs Sci. 2020 Apr 4;7(2):153-156. doi: 10.1016/j.ijnss.2020.03.012. eCollection 2020 Apr 10.
- Results publication: PubMed 33091200Comber L, Walsh KA, Jordan K, O'Brien KK, Clyne B, Teljeur C, Drummond L, Carty PG, De Gascun CF, Smith SM, Harrington P, Ryan M, O'Neill M. Alternative clinical specimens for the detection of SARS-CoV-2: A rapid review. Rev Med Virol. 2021 Jul;31(4):e2185. doi: 10.1002/rmv.2185. Epub 2020 Oct 22.
- Individual participant dataSharing planned: Yes. The data underlying this article are available in figshare 10.6084/m9.figshare.24064218
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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.
Thananda Trakarnvanich, M.D. principal investigator
Navamindradhiraj University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SARS-CoV-2 RNA detection in people with SARS-CoV-2 Virus, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
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 15 Nov 2024. 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 Thailand. 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?
the efficacy of SARS-CoV-2 RNA detection from used surgical masks (time frame: 3 months). 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 NCT06027398, which also lists 4 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 15 Nov 2024.