A New Screening Strategy for 2019 Novel Coronavirus Infection

Novel Coronavirus Infection Pneumonia Clinical Trial

Official title:

Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04281693
• Other study ID #: 307-nCoV
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2020
• Est. completion date: March 2020

Study information

• Verified date: February 2020
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Xiaotian Sun
• Phone: +86-01066823480
• Email: xiaotian-sun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Confirmed NCIP patients

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• Infection
• Novel Coronavirus Infection Pneumonia
• Pneumonia
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• Standard screening strategy
The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by individual testing.
• New screening strategy
The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by minipool testing.

Locations

Country	Name	City	State
China	the Fifth Medical Center of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences	The Fifth Medical Center of Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 17;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. [Epub ahead of print] Chinese. — View Citation

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 Feb 7. doi: 10.1001/jama.2020.1585. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening accuracy	The screening accuracy of the two screening strategies were calculated and compared.	1 month
Secondary	Cost-effectiveness analysis	The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.	1 month