Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT06968156
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2025-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Monocyte Values Accompanied by Lymphopenia on the Prognosis of Patients Diagnosed With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2025-05-01', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prognostic course, rate of mortality', 'timeFrame': 'through study completion, an average of 5 month', 'description': 'The parameters examined will be survival and exitus status, age, weight in kilograms, height in centimeters, weight and height will be combined to report BMI in kg/m\\^2, gender, presence of additional disease, ferritin, D-dimer, C-reactive protein, lactate dehydrogenase, procalcitonin, fibrinogen, hemoglobin, leukocyte, platelet, neutrophil, eosinophil, basophil, monocyte, lymphocyte levels measured during admission to the intensive care unit. Lymphocyte-monocyte ratio, neutrophil-lymphocyte ratio and platelet-lymphocyte ratio will be obtained from the detected data. The existing O2 requirement at admission to the intensive care unit was recorded retrospectively as fractional inspired oxygen (FiO2) value, the source of oxygen support and the existing Covid-19 treatment. The hemodialysis, vasopressor and intubation requirement that developed during the hospitalization and the exitus status during hospitalization were evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID 19', 'Lymphopenia Due to COVID-19', 'Monocyte']}, 'descriptionModule': {'briefSummary': 'Recent studies have shown that lymphopenia with cytokine storm syndrome is frequently found in COVID-19 patients. These features may suggest that the modified immune system plays a key role in determining disease progression. Lymphopenia or lymphocytopenia is a condition in which the number of lymphocytes in the blood is low. Although T cells can be increased at the onset of COVID-19, these patients tend to have low lymphocyte counts, which is associated with increased COVID-19 severity. Thus, individuals who died of COVID-19 have been shown to have significantly lower lymphocyte levels than survivors. There is evidence that myeloid cells play a role in the pathophysiology of coronavirus infection, either directly as virus targets or indirectly as effectors of cytokine release syndrome. Monocytes are innate hematopoietic cells that maintain vascular homeostasis and provide early responses to pathogens during acute infections. The role of monocytes and macrophages in the resolution of inflammation has also been emphasized as an important component of the response to SARS-CoV-2. Accordingly, it was investigated whether the change observed in blood monocyte levels was an effective parameter in the prognosis process in Covid-19 cases with lymphopenia, considering that monocyte levels could be useful as a guide in the course of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study was conducted among patients admitted to the intensive care unit of a tertiary hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18\n* Male and female of both genders\n* Admitted to the intensive care unit\n* Diagnosed with Covid-19 with lymphopenia\n* Patients with confirmed COVID-19 diagnosis in polymerase chain reaction (PCR) tests performed on nasopharyngeal swab samples\n\nExclusion Criteria:\n\n* Those with a negative PCR test\n* Aged 18 and under'}, 'identificationModule': {'nctId': 'NCT06968156', 'briefTitle': 'The Effect of Monocyte Values Accompanied by Lymphopenia on the Prognosis of Patients Diagnosed With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'The Effect of Monocyte Values Accompanied by Lymphopenia on the Prognosis of Patients Diagnosed With COVID-19', 'orgStudyIdInfo': {'id': 'KAEK/2021.04.142'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group monocytopenia'}, {'label': 'Group control'}, {'label': 'Group monocytosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Suleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology and Reanimation specialist', 'investigatorFullName': 'Naime Yalçın', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}