Clinical Features of Suspected and Confirmed Patients of 2019 Novel Coronavirus Infection
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| ClinicalTrials.gov Identifier: NCT04279782 |
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Recruitment Status :
Recruiting
First Posted : February 21, 2020
Last Update Posted : February 24, 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 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 |
Survival rate [ Time Frame: 28 days ] If the patient will survive after comprehensive treatment
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| 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 |
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| 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.
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| Study Groups/Cohorts |
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| Publications * | Peng L, Liu J, Xu W, Luo Q, Chen D, Lei Z, Huang Z, Li X, Deng K, Lin B, Gao Z. SARS-CoV-2 can be detected in urine, blood, anal swabs, and oropharyngeal swabs specimens. J Med Virol. 2020 Sep;92(9):1676-1680. doi: 10.1002/jmv.25936. Epub 2020 Apr 30. | ||||||||
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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 |
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:
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 | NCT04279782 | ||||||||
| Other Study ID Numbers | XWX3 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| 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 | ||||||||