Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations

Coronavirus Clinical Trial

Official title:

Study on Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations in Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04279795
• Other study ID #: PL11
• Status: Recruiting
• Start date: January 20, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2020
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Wenxiong Xu, Doctor
• Phone: +8613760783281
• Email: xwx1983[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Outbreak of 2019 Novel Coronavirus infection quickly spread to the world. Confirmed patients were isolated and treated in our department. 2019 Novel Coronavirus was detected in multiple organ system. Clinical data was recorded to investigate the its relationship with viral detection.

Description:

Medical date of suspected patients of 2019 Novel Coronavirus infection, who came to outpatient department of the Third Affiliated Hospital of Sun Yat-sen University, were sent to an expert group if they met the inclusion criteria. The expert group discussed and made a decision if the patient would be admission to isolation unit. Pharyngeal swabs of the patients were obtained and sent to local Center for Disease Control and Prevention (CDC) for detection the 2019 Novel Coronavirus after patients were admission to isolation unit. Diagnosis of 2019 Novel Coronavirus infection was confirmed if the result was positive or excluded if two consecutive results were negative. Patients' demographic data and clinical characteristics were recorded. Clinical characteristics including epidemiological history, past history, personal history, symptoms, signs, blood cells count, biochemical test results, chest computed tomography (CT) images. 2019 Novel Coronavirus RNA was detected in pharyngeal swab, anal swab, urine and blood samples by using quantitative real-time polymerase chain reaction (qPCR). Comprehensive treatments were given to the patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Epidemiological history including resident of Hubei province, or travel history to Hubei province or exposure to suspected patients in the past two weeks.

2. Symptoms like fever, fatigue, myalgia, headache, cough, sputum production, chest tightness, dyspnea, etc.

3. White blood cells decreased or were normal, or lymphocytes decreased, and chest CT images showed typical findings of viral pneumonia.

4. Detection of 2019 Novel Coronavirus nucleic acid is positive by local Center for Disease Control and Prevention (CDC).

Exclusion Criteria:

1. Patients can not follow-up;

2. Investigator considering inappropriate.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive rate of 2019 Novel Coronavirus RNA	rate of positive results of detection 2019 Novel Coronavirus nucleic acid from urine, blood, anal swabs and pharyngeal swabs samples	28 days
Secondary	Survival rate	If the patient will survive after comprehensive treatment	28 days