A New Screening Strategy for 2019 Novel Coronavirus Infection

Affiliated Hospital to Academy of Military Medical Sciences

Status: Unknown

Conditions: Novel Coronavirus Infection Pneumonia

Treatments: Diagnostic Test: New screening strategy; Diagnostic Test: Standard screening strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT04281693

307-nCoV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Confirmed NCIP patients

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

Screening participants

Experimental group

Treatment:

Diagnostic Test: New screening strategy

Diagnostic Test: Standard screening strategy