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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

Tracking Information
First Submitted Date February 15, 2020
First Posted Date February 21, 2020
Last Update Posted Date February 24, 2020
Actual Study Start Date January 20, 2020
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2020)
Survival rate [ Time Frame: 28 days ]
If the patient will survive after comprehensive treatment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 20, 2020)
  • Chest computed tomography [ Time Frame: 28 days ]
    Images of chest computed tomography are obtained to find out the changes in the course of treatment
  • Recovery Time [ Time Frame: 28 days ]
    Time for recovery from admission to discharged
  • 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.
Original Secondary Outcome Measures
 (submitted: February 19, 2020)
  • Chest computed tomography [ Time Frame: 28 days ]
    Images of chest computed tomography are obtained to find out the changes in the course of treatment
  • Recovery Time [ Time Frame: 28 days ]
    Time for recovery from admission to discharged
  • Self-rating depression scale [ Time Frame: 28 days ]
    Self-rating depression scale will be finished from patients and medical staff
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Suspected patients of 2019 Novel Coronavirus infection
Condition Coronavirus
Intervention Other: Comprehensive treatment
Comprehensive treatment includes antiviral therapy, antibiotics therapy, symptomatic treatment, supportive therapy.
Study Groups/Cohorts
  • Exclusion group
    Patients with two consecutive negative results of detection for 2019 Novel Coronavirus nucleic acid from pharyngeal swabs
    Intervention: Other: Comprehensive treatment
  • Confirmed group
    Patients with positive result of detection for 2019 Novel Coronavirus nucleic acid from pharyngeal swab
    Intervention: Other: Comprehensive treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 19, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Wenxiong Xu, Doctor +8613760783281 xwx1983@163.com
Contact: Liang Peng, Doctor +8613533978874 pzp33@hotmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04279782
Other Study ID Numbers XWX3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
Study Sponsor Third Affiliated Hospital, Sun Yat-Sen University
Collaborators Not Provided
Investigators
Principal Investigator: Liang Peng, Doctor Third Affiliated Hospital of Sun Yat-sen University
PRS Account Third Affiliated Hospital, Sun Yat-Sen University
Verification Date February 2020