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A New Screening Strategy for 2019 Novel Coronavirus Infection

Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04281693
Enrollment
230
Registered
2020-02-24
Start date
2020-02-29
Completion date
2020-03-31
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Infection Pneumonia

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.

Interventions

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

DIAGNOSTIC_TESTNew screening strategy

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

Sponsors

Beijing 302 Hospital
CollaboratorOTHER
Affiliated Hospital to Academy of Military Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Confirmed NCIP patients

Design outcomes

Primary

MeasureTime frameDescription
Screening accuracy1 monthThe screening accuracy of the two screening strategies were calculated and compared.

Secondary

MeasureTime frameDescription
Cost-effectiveness analysis1 monthThe costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.

Countries

China

Contacts

Primary ContactXiaotian Sun
xiaotian-sun@hotmail.com+86-01066823480
Backup ContactZheng Lu
13818223446@163.com+86-01066823480

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026