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

February 19, 2020 updated by: Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Confirmed patients of 2019 Novel Coronavirus infection

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Anticipated)

January 31, 2021

Study Completion (Anticipated)

February 28, 2021

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PL11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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