Coronavirus Disease 2019COVID-19NCT05092568
Comparison of General Characteristics of Patients Diagnosed COVID-19 (Coronavirus )Positive Followed In Service
An observational study of Coronavirus Disease 2019 and Vaccinia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
comparison of general characteristics of patients diagnosed COVID-19 positive followed In service Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Coronavirus Disease 2019, Vaccinia, Symptoms and Signs
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2022to 15 Jul 2022
- How long will I take part?
- 2 Months
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant patients with positive COVID-19 test results, who were followed up and treated in the pandemic service of Çam and Sakura City Hospital.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Maternal-Fetal Medicine Unit, Başakşehir City Hospital, Hamidiye School of Medicine, University of Health Sciences,
Başaksehir, Istanbul, 34480
özge Ö özdemir, MD, 05326384089, drozgeozde@gmail.com
About this study
Official title: Comparison of General Characteristics of Patients Diagnosed COVID-19 Positive Followed In Service
comparison of general characteristics of patients diagnosed COVID-19 positive followed In service
Read the detailed description
After the explanation about the study is made, informed consent form will be obtained from the pregnant women who were hospitalized in the pandemic gynecology service (D block 10th floor pandemic obstetrics service) due to COVID-19 and who agreed to participate in the study. In our study, the clinical status of pregnant patients with COVID-19 positive test results, who were followed up and treated in the pandemic service in Basaksehir City Hospital, will be obtained by asking the patient about the symptoms and vaccination status in the patient follow-up form prepared in advance. Laboratory findings and imaging results ( CT/ anteroposterior X-ray) will be obtained from the recorded data.
- Conditions
- Coronavirus Disease 2019, Vaccinia, Symptoms and Signs
- Keywords
- covid 19,, vaccine, covid pregnancy vaccine
- Medical subject headings
- COVID-19, Vaccinia, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| covid pregnancy | Pregnant patients with positive polymerase chain reaction assay COVID-19 test results, who were followed up and treated in the pandemic service of Başakşehir Çam and Sakura City Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants
Number of Participants diagnosed of polymerase chain reaction assay Positive COVID-19 followed İn service
Measured: Two months
Number of vaccinated participants
Vaccinated patients who were followed up in the service due to COVID-19
Measured: Two months
Number of non-vaccinated Participants
non-vaccinated patients who were followed up in the service due to COVID-19
Measured: Two months
rate of non-vaccinated -vaccinated Participants
rate of non-vaccinated- vaccinated Participants who were followed up in the service due to COVID-19
Measured: Two months
rate of covid symptoms
rate of covid common symptoms (cough, fever, shortness of breath ,sore throat ) in vaccinated and unvaccinated patients
Measured: Two months
rate of inflammatory parameters
rate of lymphocyte and albumin levels , C-reactive protein (CRP), D-dimer, Ferritin, lactate dehydrogenase(LDH), neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR) and C-reactive protein albumin ratio (CAR) levels in vaccinated and unvaccinated patients
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start5 May 2022
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Özge Özdemir, Saglik Bilimleri Universitesi
- Investigators
- Ozge Ozdemir, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092568
- Sponsor's protocol ID
- COVID-19
- Acronym
- COVID-19
- Status last verified
- May 2022
- First submitted
- 22 Oct 2021
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of General Characteristics of Patients Diagnosed COVID-19 Positive Followed In Service
- ClinicalTrials.gov ID
- NCT05092568
- Acronym / sponsor ID
- COVID-19 / COVID-19
- Conditions
- Coronavirus Disease 2019, Vaccinia, Symptoms and Signs
- Keywords
- covid 19,, vaccine, covid pregnancy vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 25 Oct 2021 (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.
comparison of general characteristics of patients diagnosed COVID-19 positive followed In service
Detailed description
After the explanation about the study is made, informed consent form will be obtained from the pregnant women who were hospitalized in the pandemic gynecology service (D block 10th floor pandemic obstetrics service) due to COVID-19 and who agreed to participate in the study. In our study, the clinical status of pregnant patients with COVID-19 positive test results, who were followed up and treated in the pandemic service in Basaksehir City Hospital, will be obtained by asking the patient about the symptoms and vaccination status in the patient follow-up form prepared in advance. Laboratory findings and imaging results ( CT/ anteroposterior X-ray) will be obtained from the recorded data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| covid pregnancy | – | –Pregnant patients with positive polymerase chain reaction assay COVID-19 test results, who were followed up and treated in the pandemic service of Başakşehir Çam and Sakura City Hospital. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant patients with positive COVID-19 test results, who were followed up and treated in the pandemic service of Çam and Sakura City Hospital.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants
Time frame: Two months
Number of Participants diagnosed of polymerase chain reaction assay Positive COVID-19 followed İn service
Number of vaccinated participants
Time frame: Two months
Vaccinated patients who were followed up in the service due to COVID-19
Number of non-vaccinated Participants
Time frame: Two months
non-vaccinated patients who were followed up in the service due to COVID-19
rate of non-vaccinated -vaccinated Participants
Time frame: Two months
rate of non-vaccinated- vaccinated Participants who were followed up in the service due to COVID-19
rate of covid symptoms
Time frame: Two months
rate of covid common symptoms (cough, fever, shortness of breath ,sore throat ) in vaccinated and unvaccinated patients
rate of inflammatory parameters
Time frame: Two months
rate of lymphocyte and albumin levels , C-reactive protein (CRP), D-dimer, Ferritin, lactate dehydrogenase(LDH), neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR) and C-reactive protein albumin ratio (CAR) levels in vaccinated and unvaccinated patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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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.
Ozge Ozdemir principal investigator
Saglik Bilimleri Universitesi
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 Coronavirus Disease 2019 and Vaccinia, run by Saglik Bilimleri Universitesi 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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozge MD Ozdemir, MD (9005326384089, drozgeozde@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants (time frame: Two months). The study lists 6 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 6 May 2022.