- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04281693
A New Screening Strategy for 2019 Novel Coronavirus Infection
February 21, 2020 updated by: Affiliated Hospital to Academy of Military Medical Sciences
Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaotian Sun
- Phone Number: +86-01066823480
- Email: xiaotian-sun@hotmail.com
Study Contact Backup
- Name: Zheng Lu
- Phone Number: +86-01066823480
- Email: 13818223446@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100071
- The Fifth Medical Center of Chinese PLA General Hospital
-
Contact:
- Yan Liu, Ph.D.
- Phone Number: 010-66947473
- Email: 13911798288@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Who agree to participate in the study and sign written informed consent
Exclusion Criteria:
- Confirmed NCIP patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Screening participants
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Screening accuracy
Time Frame: 1 month
|
The screening accuracy of the two screening strategies were calculated and compared.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness analysis
Time Frame: 1 month
|
The costs of the two screening strategies were recorded.
Cost-effectiveness analysis were performed and compared.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yan Liu, Beijing 302 Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- Epidemiology 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2020
Primary Completion (Anticipated)
March 1, 2020
Study Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
February 20, 2020
First Submitted That Met QC Criteria
February 21, 2020
First Posted (Actual)
February 24, 2020
Study Record Updates
Last Update Posted (Actual)
February 24, 2020
Last Update Submitted That Met QC Criteria
February 21, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 307-nCoV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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