Clinical trial NCT04279782: Clinical Features of Suspected and Confirmed Patients of 2019 Novel Coronavirus Infection
Official title: Investigation on Clinical Features of Suspected and Confirmed Patients of 2019 Novel Coronavirus Infection in Isolation Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus
Keywords: 2019 Novel Coronavirus
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suspected patients of 2019 Novel Coronavirus infection

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival rate
timeFrame: 28 days
Secondary outcomes:
measure: Chest computed tomography
timeFrame: 28 days
measure: Recovery Time
timeFrame: 28 days
measure: Depression evaluation
timeFrame: 28 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peng L, Liu J, Xu W, Luo Q, Chen D, Lei Z, Huang Z, Li X, Deng K, Lin B, Gao Z. SARS-CoV-2 can be detected in urine, blood, anal swabs, and oropharyngeal swabs specimens. J Med Virol. 2020 Sep;92(9):1676-1680. doi: 10.1002/jmv.25936. Epub 2020 Apr 30.