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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigation on Clinical Features of Suspected and Confirmed Patients of 2019 Novel Coronavirus Infection in Isolation Unit

Conditions
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Coronavirus

Intervention / Treatment
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* Other: Comprehensive treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epidemiological history including resident of Hubei province, or travel history to Hubei province or exposure to suspected patients in the past two weeks. Symptoms like fever, fatigue, myalgia, headache, cough, sputum production, chest tightness, dyspnea, etc. White blood cells decreased or were normal, or lymphocytes decreased, and chest CT images showed typical findings of viral pneumonia. Exclusion Criteria: Patients can not follow-up; Investigator considering inappropriate.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exclusion group<br>Patients with two consecutive negative results of detection for 2019 Novel Coronavirus nucleic acid from pharyngeal swabs | Other: Comprehensive treatment<br>* Comprehensive treatment includes antiviral therapy, antibiotics therapy, symptomatic treatment, supportive therapy.<br>|
| Confirmed group<br>Patients with positive result of detection for 2019 Novel Coronavirus nucleic acid from pharyngeal swab | Other: Comprehensive treatment<br>* Comprehensive treatment includes antiviral therapy, antibiotics therapy, symptomatic treatment, supportive therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | If the patient will survive after comprehensive treatment | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest computed tomography | Images of chest computed tomography are obtained to find out the changes in the course of treatment | 28 days | 
| Recovery Time | Time for recovery from admission to discharged | 28 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2019 Novel Coronavirus