- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328454
Clinical Characteristics and Prognostic Factors of Patients With COVID-19
March 30, 2020 updated by: Ming Li, Shanghai 10th People's Hospital
Clinical Characteristics and Prognostic Factors of Patients With COVID-19 in Chibi Hospital of Hubei Province
As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths.
Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission.
The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.
Study Overview
Detailed Description
As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths.
Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission.
The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.
Study Type
Observational
Enrollment (Anticipated)
120
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
-
-
Shanghai
-
Shanghai, Shanghai, China, +86200072
- Recruiting
- Shanghai 10th People's Hospital
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with COVID-19
Description
Inclusion Criteria:
- Adult aged >=18years old; Diagnosed with CONVID19. Diagnostic criteria including: Laboratory (RT-PCR) confirmed SARS-Cov-2 infection; CT of the lung conformed to the manifestation of viral pneumonia.
Exclusion Criteria:
- Near-death state (expected survival time less than 24 hours); Malignant tumor; Pregnancy or puerperium women; Patients who refused to participant.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
COVID-19 patients
Hospitalized patients with COVID-19
|
The investigators retrospectively analyzed the hospitalized patients with COVID-19
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to negative conversion of severe acute respiratory syndrome coronavirus 2
Time Frame: 1 month
|
The primary outcome is the time to negative conversion of coronavirus
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of stay in hospital
Time Frame: 1 month
|
The time of hospitalization
|
1 month
|
|
Survival
Time Frame: 1 month
|
The rate of survival within hospitalization of these patients will be tracked.
The rate of survival within hospitalization of these patients will be tracked.
The rate of survival within hospitalization of these patients will be tracked.
The rate of survival within hospitalization of these patients will be tracked.
|
1 month
|
|
Intubation
Time Frame: 1 month
|
The rate of intubation within hospitalization of these patients will be tracked
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 30, 2020
Primary Completion (ANTICIPATED)
April 2, 2020
Study Completion (ANTICIPATED)
April 15, 2020
Study Registration Dates
First Submitted
March 27, 2020
First Submitted That Met QC Criteria
March 30, 2020
First Posted (ACTUAL)
March 31, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 31, 2020
Last Update Submitted That Met QC Criteria
March 30, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBCBH-IEC-2020-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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