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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04279782
Other study ID # XWX3
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
Study type Observational

Clinical Trial Summary

Outbreak of 2019 Novel Coronavirus infection started in Wuhan and quickly spread to the world. Suspected patients were isolated and treated in our department. Clinical data was recorded to investigate the clinical features of patients confirmed and excluded diagnosed of 2019 Novel Coronavirus infection.


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 and treatment. Comprehensive treatments were given to the patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
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.

Exclusion Criteria:

1. Patients can not follow-up;

2. Investigator considering inappropriate.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Comprehensive treatment
Comprehensive treatment includes antiviral therapy, antibiotics therapy, symptomatic treatment, supportive therapy.

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 Survival rate If the patient will survive after comprehensive treatment 28 days
Secondary Chest computed tomography Images of chest computed tomography are obtained to find out the changes in the course of treatment 28 days
Secondary Recovery Time Time for recovery from admission to discharged 28 days
Secondary Depression evaluation A self-rating depression scale (SCL-90) will be finished from patients and medical staff. There are 90 questions. Each question scores from 1 to 5. Minimum score is 90, maximun score is 450. High scores indicate poor condition. 28 days
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