SARS-COV-2 Detection From Used Surgical Mask

NCT06027398 | Completed DMC

• 1 other identifier: 138/64
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

SARS-CoV-2 Virus

Keywords

Nasopharyngeal swab; RT-PCR; SARS-CoV-2; surgical mask

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Study Arms (1)

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.

Diagnostic Test: SARS-CoV-2 RNA detection

Interventions

SARS-CoV-2 RNA detection DIAGNOSTIC_TEST

SARS-CoV-2 RNA detection in used mask filters

SARS-CoV-2 RNA in masks

Eligibility Criteria

• Age: Up to 80 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• require oxygen intubation or any breathing support devices

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (1)

2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand

Bangkok, 10400, Thailand

Location

Related Publications (4)

• 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.

  PMID: 32015508 RESULT

• Gao 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.

  PMID: 32376603 RESULT

• Qian 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.

  PMID: 32292635 RESULT

• Comber 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.

  PMID: 33091200 RESULT

Study Officials

• Thananda Trakarnvanich, M.D.

  Navamindradhiraj University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: To compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: May 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

TH (1)