A New Screening Strategy for 2019 Novel Coronavirus Infection

NCT ID: NCT04281693

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Novel Coronavirus Infection Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening participants

Group Type EXPERIMENTAL

Standard screening strategy

Intervention Type DIAGNOSTIC_TEST

The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by individual testing.

New screening strategy

Intervention Type DIAGNOSTIC_TEST

The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by minipool testing.

Interventions

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Standard screening strategy

The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by individual testing.

Intervention Type DIAGNOSTIC_TEST

New screening strategy

The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by minipool testing.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Confirmed NCIP patients
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing 302 Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Liu

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

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the Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiaotian Sun

Role: CONTACT

+86-01066823480

Zheng Lu

Role: CONTACT

+86-01066823480

Facility Contacts

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Yan Liu, Ph.D.

Role: primary

010-66947473

References

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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.

Reference Type BACKGROUND
PMID: 32031570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32064853 (View on PubMed)

Other Identifiers

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307-nCoV

Identifier Type: -

Identifier Source: org_study_id

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