Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Clinical Parameters on Admission and Medications in Covid-19 Pneumonia (Corona Virus Disease 2019) (Covid-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04379310
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Murat Civan, Nisantasi University

Brief Summary:
Investigators will recruit patients diagnosed with COVID-19 pneumonia between March 11th, 2020 and April 15th, 2020 in emergency, internal medicine and cardiology outpatient clinics, retrospectively and analyze their clinical and demographic features on admission in regard to their medications used for chronic diseases regularly.

Condition or disease Intervention/treatment
Covid-19 Drug: ACE Inhibitors and Calcium Channel Blockers

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 5, 2020
Estimated Study Completion Date : May 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
covid-19 pneumonia
diagnosed with covid-19 by using PCR and computed tomography scans
Drug: ACE Inhibitors and Calcium Channel Blockers
effect of drugs on patients with covid-19 pneumonia
Other Name: NSAID




Primary Outcome Measures :
  1. extend of lung involvement [ Time Frame: 1 week ]
    number of segments involved on admission

  2. oxygen saturation on admission [ Time Frame: 2 week ]
    hypoxia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
first diagnosis with covid-19 pneumonia
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379310


Contacts
Layout table for location contacts
Contact: Murat Civan, M.D. +905057479756 murat.civan@nisantasi.edu.tr

Locations
Layout table for location information
Turkey
Vital Hospital Recruiting
Bahcelievler, Istanbul, Turkey, 34230
Contact: Hasan Haciosman, M.D.    +902125574000    info@vitalhospital.com.tr   
Principal Investigator: Murat Civan, M.D.         
Sponsors and Collaborators
Nisantasi University
Investigators
Layout table for investigator information
Study Chair: Hasan Haciosman academic staff, MD
Layout table for additonal information
Responsible Party: Murat Civan, M.D., Nisantasi University
ClinicalTrials.gov Identifier: NCT04379310    
Other Study ID Numbers: 20200504441
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: patient characteristics and time interval will be shared
Supporting Materials: Study Protocol
Time Frame: in two months
Access Criteria: all researchers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murat Civan, Nisantasi University:
covid-19 pneumonia
medication
comorbidity
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Calcium
Angiotensin-Converting Enzyme Inhibitors
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Membrane Transport Modulators