Covid-19Covid-19NCT04379310
Evaluation of Clinical Parameters on Admission and Medications in Covid-19 Pneumonia (Corona Virus Disease 2019)
An observational study of Covid-19, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Covid-19
- What is being tested?
- ACE Inhibitors and Calcium Channel Blockers
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 8 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: first diagnosis with covid-19 pneumonia
Who may be able to join
- Covid-19 pneumonia at least with typical infiltration on CT +/- positive PCR.
Who cannot join
- no typical infiltration and negative PCR results.
- not newly diagnosed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Covid-19
- Being tested
- ACE Inhibitors and Calcium Channel Blockers
- Keywords
- covid-19 pneumonia, medication, comorbidity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE Inhibitors and Calcium Channel BlockersDrug
Also called NSAID
effect of drugs on patients with covid-19 pneumonia
| Study group | Role | What they receive |
|---|---|---|
| covid-19 pneumonia | diagnosed with covid-19 by using PCR and computed tomography scans Receives: Drug: ACE Inhibitors and Calcium Channel Blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
extend of lung involvement
number of segments involved on admission
Measured: 1 week
oxygen saturation on admission
hypoxia
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 May 2020
- Primary completion5 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Nisantasi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Civan, Istanbul Nisantasi University
- Investigators
- Hasan Haciosman, Study chair, academic staff, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379310
- Sponsor's protocol ID
- 20200504441
- Acronym
- Covid-19
- Status last verified
- Jun 2020
- First submitted
- 4 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: patient characteristics and time interval will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04379310
- Acronym / sponsor ID
- Covid-19 / 20200504441
- Conditions
- Covid-19
- Keywords
- covid-19 pneumonia, medication, comorbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Istanbul Nisantasi UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| covid-19 pneumonia | – | Drug: ACE Inhibitors and Calcium Channel Blockersdiagnosed with covid-19 by using PCR and computed tomography scans |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- first diagnosis with covid-19 pneumonia
Key inclusion criteria (1 listed)
- Covid-19 pneumonia at least with typical infiltration on CT +/- positive PCR.
Key exclusion criteria (2 listed)
- no typical infiltration and negative PCR results.
- not newly diagnosed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE Inhibitors and Calcium Channel BlockersAlso: NSAIDeffect of drugs on patients with covid-19 pneumonia | Drug | covid-19 pneumonia |
Primary outcome
extend of lung involvement
Time frame: 1 week
number of segments involved on admission
oxygen saturation on admission
Time frame: 2 week
hypoxia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Yes. patient characteristics and time interval will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Haciosman study chair
academic staff, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extend of lung involvement (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.