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Trial record 2 of 1340 for:    Recruiting, Active, not recruiting, Completed, Enrolling by invitation Studies | Coronavirus

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

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ClinicalTrials.gov Identifier: NCT04279782
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Liang Peng, 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.

Condition or disease Intervention/treatment
Coronavirus Other: Comprehensive treatment

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation on Clinical Features of Suspected and Confirmed Patients of 2019 Novel Coronavirus Infection in Isolation Unit
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Exclusion group
Patients with two consecutive negative results of detection for 2019 Novel Coronavirus nucleic acid from pharyngeal swabs
Other: Comprehensive treatment
Comprehensive treatment includes antiviral therapy, antibiotics therapy, symptomatic treatment, supportive therapy.

Confirmed group
Patients with positive result of detection for 2019 Novel Coronavirus nucleic acid from pharyngeal swab
Other: Comprehensive treatment
Comprehensive treatment includes antiviral therapy, antibiotics therapy, symptomatic treatment, supportive therapy.




Primary Outcome Measures :
  1. Survival rate [ Time Frame: 28 days ]
    If the patient will survive after comprehensive treatment


Secondary Outcome Measures :
  1. Chest computed tomography [ Time Frame: 28 days ]
    Images of chest computed tomography are obtained to find out the changes in the course of treatment

  2. Recovery Time [ Time Frame: 28 days ]
    Time for recovery from admission to discharged

  3. Depression evaluation [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Suspected patients of 2019 Novel Coronavirus infection
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279782


Contacts
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Contact: Wenxiong Xu, Doctor +8613760783281 xwx1983@163.com
Contact: Liang Peng, Doctor +8613533978874 pzp33@hotmail.com

Locations
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China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Liang Peng, Doctor    +8613533978874    pzp33@hotmail.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Liang Peng, Doctor Third Affiliated Hospital, Sun Yat-Sen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liang Peng, Professer, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04279782    
Other Study ID Numbers: XWX3
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University:
2019 Novel Coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases