- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379310
Evaluation of Clinical Parameters on Admission and Medications in Covid-19 Pneumonia (Corona Virus Disease 2019) (Covid-19)
Evaluation of Demographic and Clinical Parameters on Admission and Medications Used for Comorbidities in Patients With Covid-19 Pneumonia: A Single Center Experience in Turkey
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Covid-19 infections demonstrated a pandemic spread after January 2020 and their associations with patient characteristics and comorbidities are intensely studied. Investigators also want to find out potential relations between major medications taken for chronic diseases and clinical parameters of patients with Covid-19 pneumonia.
For the study, investigators will recruit patients diagnosed with COVID-19 pneumonia between March 11th, 2020 (the date at which the first case of Covid-19 in Turkey officially declared) and April 15th, 2020 in emergency, internal medicine and cardiology outpatient clinics, retrospectively. All of the demographic features, complaints on admission, reports of computed tomography (CT) scans of the chest without intravenous contrast issued by the staff radiologist, c-reactive protein (CRP) and complete blood count (CBC) values on admission will be recorded retrospectively. Their polymerase chain reaction (PCR) test results will be derived from the hospital records based on public health covid-19 database notifications and list of medications taken regularly for more than 8 weeks before the diagnosis of COVID-19 pneumonia from the national pharmacy database. Information about other systemic diseases and major medical conditions of patients will be procured from the medical histories gained by relevant physicians. Patient taking each drug group will be compared to those not taking that drugs in terms of clinical and demographical features mentioned above. Statistical analysis will be performed by using SPSS software.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Istanbul
-
Bahcelievler, Istanbul, Turkey, 34230
- Vital Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Covid-19 pneumonia at least with typical infiltration on CT +/- positive PCR.
Exclusion Criteria:
- no typical infiltration and negative PCR results.
- not newly diagnosed.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
covid-19 pneumonia
diagnosed with covid-19 by using PCR and computed tomography scans
|
effect of drugs on patients with covid-19 pneumonia
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
extend of lung involvement
Time Frame: 1 week
|
number of segments involved on admission
|
1 week
|
oxygen saturation on admission
Time Frame: 2 week
|
hypoxia
|
2 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hasan Haciosman, academic staff, MD
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Lung Diseases
- COVID-19
- Pneumonia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium
- Calcium Channel Blockers
- Angiotensin-Converting Enzyme Inhibitors
Other Study ID Numbers
- 20200504441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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