A New Screening Strategy for 2019 Novel Coronavirus Infection

Not Applicable

• Conditions: Novel Coronavirus Infection Pneumonia
• Interventions: Diagnostic Test: Standard screening strategy; Diagnostic Test: New screening strategy

• Registration Number: NCT04281693
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

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.

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 Timeline

• Status Verified: 2020-02
• Study Start: 2020-02
• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-21
• Last Update Submitted: 2020-02-21
• Study First Posted: 2020-02-24
• Last Update Posted: 2020-02-24
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

Exclusion Criteria

• Confirmed NCIP patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening participants	Standard screening strategy	-
Screening participants	New screening strategy	-

Primary Outcome Measures

Name	Time	Method
Screening accuracy	1 month	The screening accuracy of the two screening strategies were calculated and compared.

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness analysis	1 month	The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.

Trial Locations

Locations (1)

the Fifth Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China