xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06027398</url>
    </required_header>
    <id_info>
      <org_study_id>138/64</org_study_id>
      <nct_id>NCT06027398</nct_id>
    </id_info>
    <brief_title>SARS-COV-2 Detection From Used Surgical Mask</brief_title>
    <official_title>Efficacy of SARS-COV-2 Detection From Used Surgical Mask Compared to Standard Detection Method</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bangkok Metropolitan Administration Medical College and Vajira Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bangkok Metropolitan Administration Medical College and Vajira Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The real-time reverse transcription-polymerase chain reaction (RT-PCR) test is regarded as&#xD;
        the gold standard for SARS-CoV-2 detection. Proper specimen collection and obtaining a&#xD;
        sufficient sample are the most important steps for laboratory diagnosis. The nasopharyngeal&#xD;
        (NP) swab is recommended as the reference collection method. However, NP swab collection is&#xD;
        invasive and uncomfortable for patients and poses some risk to healthcare workers. This study&#xD;
        aimed to compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with the&#xD;
        NP swab method using RT-PCR testing&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Proper specimen collection and obtaining sufficient samples are the most important steps for&#xD;
        laboratory diagnosis of an infectious disease. Improper collection may lead to false or&#xD;
        inconclusive test results. During the early stages of the COVID-19 outbreak, the Center for&#xD;
        Disease Prevention and Control recommended collecting and testing an upper respiratory&#xD;
        specimen [4]. Nasopharyngeal (NP) and oropharyngeal (OP) swabs are the preferred choice for&#xD;
        initial SARS-CoV-2 diagnostic testing.&#xD;
  &#xD;
        This study aimed to compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks&#xD;
        with standard detection methods. We tested for SARS-CoV-2 RNA in masks from patients with&#xD;
        COVID-19 that had been worn for eight hours and compared this with NP swabs using RT-PCR&#xD;
        testing. Hospitalized patients with laboratory-confirmed COVID-19 were recruited to provide&#xD;
        surgical masks. Collection of used surgical mask samples by patients themselves is easy,&#xD;
        convenient, requires no sampling equipment and decreases the risk of healthcare personnel&#xD;
        exposure to COVID-19. If SARS-CoV-2 RNA can be detected on used surgical mask samples, this&#xD;
        may encourage patients to provide specimens for testing and help in early detection and&#xD;
        transmission prevention. As an alternative method to NP swabs, it may facilitate timely&#xD;
        diagnosis and treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2021</start_date>
    <completion_date type="Actual">September 30, 2021</completion_date>
    <primary_completion_date type="Actual">August 31, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>To compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the efficacy of SARS-CoV-2 RNA detection from used surgical masks</measure>
      <time_frame>3 months</time_frame>
      <description>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</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">269</enrollment>
    <condition>SARS-CoV-2 Virus</condition>
    <arm_group>
      <arm_group_label>SARS-CoV-2 RNA in masks</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>. 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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>SARS-CoV-2 RNA detection</intervention_name>
      <description>SARS-CoV-2 RNA detection in used mask filters</description>
      <arm_group_label>SARS-CoV-2 RNA in masks</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Newly confirmed SARS-CoV-2 positive cases admitted to a field hospital within 48 hours&#xD;
               or outpatient with a positive result for SARS-CoV-2&#xD;
  &#xD;
            -  Should be able to wear a mask for 8 h according to the protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  require oxygen intubation or any breathing support devices&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>N/A</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Thananda Trakarnvanich, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Navamindradhiraj University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand</name>
        <address>
          <city>Bangkok</city>
          <zip>10400</zip>
          <country>Thailand</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Thailand</country>
    </location_countries>
    <results_reference>
      <citation>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. Erratum In: Nature. 2020 Apr;580(7803):E7.</citation>
      <PMID>32015508</PMID>
    </results_reference>
    <results_reference>
      <citation>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.</citation>
      <PMID>32376603</PMID>
    </results_reference>
    <results_reference>
      <citation>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.</citation>
      <PMID>32292635</PMID>
    </results_reference>
    <results_reference>
      <citation>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.</citation>
      <PMID>33091200</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bangkok Metropolitan Administration Medical College and Vajira Hospital</investigator_affiliation>
      <investigator_full_name>Thananda Trakarnvanich</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Nasopharyngeal swab</keyword>
    <keyword>RT-PCR</keyword>
    <keyword>SARS-CoV-2</keyword>
    <keyword>surgical mask</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data underlying this article are available in figshare 10.6084/m9.figshare.24064218</ipd_description>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06027398
  org study id: 138/64
  nct id: NCT06027398
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: To compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: the efficacy of SARS-CoV-2 RNA detection from used surgical masks
  time frame: 3 months
  description: 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
  arm group label: SARS-CoV-2 RNA in masks
  arm group type: Experimental
  description: . 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.
  intervention type: Diagnostic Test
  intervention name: SARS-CoV-2 RNA detection
  description: SARS-CoV-2 RNA detection in used mask filters
  arm group label: SARS-CoV-2 RNA in masks
  criteria: 
  gender: All
  gender based: Yes
  minimum age: N/A
  maximum age: 80 Years
  healthy volunteers: No
  last name: Thananda Trakarnvanich, M.D.
  role: Principal Investigator
  affiliation: Navamindradhiraj University
  facility: 
  country: Thailand
  citation: 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. Erratum In: Nature. 2020 Apr;580(7803):E7.
  PMID: 32015508
  citation: 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
  citation: 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
  citation: 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
  responsible party type: Principal Investigator
  investigator affiliation: Bangkok Metropolitan Administration Medical College and Vajira Hospital
  investigator full name: Thananda Trakarnvanich
  investigator title: Associate Professor
  sharing ipd: Yes
  ipd description: The data underlying this article are available in figshare 10.6084/m9.figshare.24064218
  ipd info type: Statistical Analysis Plan (SAP)