Clinical Features of Suspected and Confirmed Patients of 2019 Novel Coronavirus Infection

• Conditions: Coronavirus
• Interventions: Other: Comprehensive treatment

• Registration Number: NCT04279782
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-20
• Status Verified: 2020-02
• Study First Submitted: 2020-02-15
• Study First Submitted QC: 2020-02-19
• Last Update Submitted: 2020-02-20
• Study First Posted: 2020-02-21
• Last Update Posted: 2020-02-24
• Primary Completion: 2021-01-31
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exclusion group	Comprehensive treatment	Patients with two consecutive negative results of detection for 2019 Novel Coronavirus nucleic acid from pharyngeal swabs
Confirmed group	Comprehensive treatment	Patients with positive result of detection for 2019 Novel Coronavirus nucleic acid from pharyngeal swab

Primary Outcome Measures

Name	Time	Method
Survival rate	28 days	If the patient will survive after comprehensive treatment

Secondary Outcome Measures

Name	Time	Method
Chest computed tomography	28 days	Images of chest computed tomography are obtained to find out the changes in the course of treatment
Recovery Time	28 days	Time for recovery from admission to discharged
Depression evaluation	28 days	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.

Trial Locations

Locations (1)

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China