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Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations

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ClinicalTrials.gov Identifier: NCT04279795
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
Outbreak of 2019 Novel Coronavirus infection quickly spread to the world. Confirmed patients were isolated and treated in our department. 2019 Novel Coronavirus was detected in multiple organ system. Clinical data was recorded to investigate the its relationship with viral detection.

Condition or disease
Coronavirus

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. 2019 Novel Coronavirus RNA was detected in pharyngeal swab, anal swab, urine and blood samples by using quantitative real-time polymerase chain reaction (qPCR). Comprehensive treatments were given to the patients.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations in Patients
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





Primary Outcome Measures :
  1. Positive rate of 2019 Novel Coronavirus RNA [ Time Frame: 28 days ]
    rate of positive results of detection 2019 Novel Coronavirus nucleic acid from urine, blood, anal swabs and pharyngeal swabs samples


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



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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
Confirmed 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.
  4. Detection of 2019 Novel Coronavirus nucleic acid is positive by local Center for Disease Control and Prevention (CDC).

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): NCT04279795


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 of Sun Yat-sen University
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Responsible Party: Liang Peng, Professer, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04279795    
Other Study ID Numbers: PL11
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

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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