Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations
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| ClinicalTrials.gov Identifier: NCT04279795 |
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Recruitment Status :
Recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
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Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
| Tracking Information | |||||||||
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| First Submitted Date | February 19, 2020 | ||||||||
| First Posted Date | February 21, 2020 | ||||||||
| Last Update Posted Date | February 21, 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 |
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
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
Survival rate [ Time Frame: 28 days ] If the patient will survive after comprehensive treatment
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations | ||||||||
| Official Title | Study on Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations in Patients | ||||||||
| 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. | ||||||||
| 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 | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Confirmed patients of 2019 Novel Coronavirus infection | ||||||||
| Condition | Coronavirus | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
20 | ||||||||
| 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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04279795 | ||||||||
| Other Study ID Numbers | PL11 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University | ||||||||
| Study Sponsor | Third Affiliated Hospital, Sun Yat-Sen University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Third Affiliated Hospital, Sun Yat-Sen University | ||||||||
| Verification Date | February 2020 | ||||||||