Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT05092568
Status:
UNKNOWN
Last Update Posted:
2022-05-06
First Post:
2021-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of General Characteristics of Patients Diagnosed COVID-19 (Coronavirus )Positive Followed In Service
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D014615', 'term': 'Vaccinia'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2021-10-22', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants', 'timeFrame': 'Two months', 'description': 'Number of Participants diagnosed of polymerase chain reaction assay Positive COVID-19 followed İn service'}, {'measure': 'Number of vaccinated participants', 'timeFrame': 'Two months', 'description': 'Vaccinated patients who were followed up in the service due to COVID-19'}, {'measure': 'Number of non-vaccinated Participants', 'timeFrame': 'Two months', 'description': 'non-vaccinated patients who were followed up in the service due to COVID-19'}, {'measure': 'rate of non-vaccinated -vaccinated Participants', 'timeFrame': 'Two months', 'description': 'rate of non-vaccinated- vaccinated Participants who were followed up in the service due to COVID-19'}, {'measure': 'rate of covid symptoms', 'timeFrame': 'Two months', 'description': 'rate of covid common symptoms (cough, fever, shortness of breath ,sore throat ) in vaccinated and unvaccinated patients'}, {'measure': 'rate of inflammatory parameters', 'timeFrame': 'Two months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid 19,', 'vaccine', 'covid pregnancy vaccine'], 'conditions': ['Coronavirus Disease 2019', 'Vaccinia', 'Symptoms and Signs']}, 'descriptionModule': {'briefSummary': 'comparison of general characteristics of patients diagnosed COVID-19 positive followed In service', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients with positive COVID-19 test results, who were followed up and treated in the pandemic service of Çam and Sakura City Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Pregnant patients positive COVID-19 test results followed up and treated in the pandemic service of Çam and Sakura City Hospital.\n\nExclusion Criteria: no exclusion criteria\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05092568', 'acronym': 'COVID-19', 'briefTitle': 'Comparison of General Characteristics of Patients Diagnosed COVID-19 (Coronavirus )Positive Followed In Service', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Comparison of General Characteristics of Patients Diagnosed COVID-19 Positive Followed In Service', 'orgStudyIdInfo': {'id': 'COVID-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'covid pregnancy', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34480', 'city': 'Başaksehir', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'özge Ö özdemir, MD', 'role': 'CONTACT', 'email': 'drozgeozde@gmail.com', 'phone': '05326384089'}], 'facility': 'Department of Obstetrics and Gynecology, Maternal-Fetal Medicine Unit, Başakşehir City Hospital, Hamidiye School of Medicine, University of Health Sciences,'}], 'centralContacts': [{'name': 'Ozge MD Ozdemir, MD', 'role': 'CONTACT', 'email': 'drozgeozde@gmail.com', 'phone': '9005326384089'}], 'overallOfficials': [{'name': 'Ozge Ozdemir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saglik Bilimleri Universitesi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Sevim Özge Özdemir', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}