A New Screening Strategy for 2019 Novel Coronavirus Infection
Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection
1 other identifier
interventional
230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
February 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedFebruary 24, 2020
February 1, 2020
29 days
February 20, 2020
February 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Screening accuracy
The screening accuracy of the two screening strategies were calculated and compared.
1 month
Secondary Outcomes (1)
Cost-effectiveness analysis
1 month
Study Arms (1)
Screening participants
EXPERIMENTALInterventions
The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by individual testing.
The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by minipool testing.
Eligibility Criteria
You may qualify if:
- Who agree to participate in the study and sign written informed consent
You may not qualify if:
- Confirmed NCIP patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100071, China
Related Publications (2)
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PMID: 32031570BACKGROUNDEpidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PMID: 32064853BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Liu
Beijing 302 Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2020
First Posted
February 24, 2020
Study Start
February 1, 2020
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
February 24, 2020
Record last verified: 2020-02