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A New Screening Strategy for 2019 Novel Coronavirus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04281693
Recruitment Status : Unknown
Verified February 2020 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Beijing 302 Hospital
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Study Description
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Brief Summary:
Since Dec 2019, over 70000 novel coronavirus infection pneumonia (NCIP) patients were confirmed. 2019 novel coronavirus (2019 nCoV) is a RNA virus, which spread mainly from person-to-person contact. Most of the symptoms are non-specific, including fever, fatigue, dry cough. Sever NCIP patients may have shortness of breath and dyspnea, and progress to acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The mortality is reported to be around 2.3%. Thus, early detection and early treatment is very important to the improvement of NCIP patients' prognosis. At present, NCIP RNA detection of pharyngeal swab specimen by RT-PCR is recommended. However, due to the universal susceptibility to 2019 nCoV in general population and limited number of NCIP RNA detection kits available, to identify an efficient screening strategy is urgently needed. This study aim to develop and validate the diagnostic accuracy and screening efficiency of a new NCIP screening strategy, which can benefit the disease prevention and control.

Condition or disease Intervention/treatment Phase
Novel Coronavirus Infection Pneumonia Diagnostic Test: Standard screening strategy Diagnostic Test: New screening strategy Not Applicable

Detailed Description:
This clinical trial is designed to compare the screen accuracy and efficiency of two screening strategies. Considering that the general population is susceptible to 2019 nCoV, a great number of people need to be screened for NCIP. The new screening strategy of minipool testing may not only obtain a comparable accuracy to the standard individual testing, but also save time and money, which may benefit the current clinical practice.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Screening participants Diagnostic Test: Standard screening strategy
The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by individual testing.

Diagnostic Test: New screening strategy
The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by minipool testing.


Outcome Measures
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Primary Outcome Measures :
  1. Screening accuracy [ Time Frame: 1 month ]
    The screening accuracy of the two screening strategies were calculated and compared.


Secondary Outcome Measures :
  1. Cost-effectiveness analysis [ Time Frame: 1 month ]
    The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Who agree to participate in the study and sign written informed consent

Exclusion Criteria:

  • Confirmed NCIP patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281693


Contacts
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Contact: Xiaotian Sun +86-01066823480 xiaotian-sun@hotmail.com
Contact: Zheng Lu +86-01066823480 13818223446@163.com

Locations
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China, Beijing
the Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing, China, 100071
Contact: Yan Liu, Ph.D.    010-66947473    13911798288@163.com   
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Beijing 302 Hospital
Investigators
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Principal Investigator: Yan Liu Beijing 302 Hospital
More Information
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Publications:

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Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT04281693    
Other Study ID Numbers: 307-nCoV
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Coronavirus Infections
COVID-19
Disease Attributes
Pathologic Processes
Pneumonia
Respiratory Tract Infections
 Lung Diseases
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Pneumonia, Viral