An observational study in Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal Swab, Symptomatic Covid -19 Positive Patients Who Require Hospitalization and Patients Who Did Not Vaccinate Against Covid-19, sponsored by Saglik Bilimleri Universitesi. Status unknown at 1 site in Turkey. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-10.
Sponsored by Saglik Bilimleri Universitesi · Observational
The primary aim of our study is to understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade, and secondarily, to investigate its utility in predicting disease prognosis by analyzing serum PAI-1 levels in patients with different severity. The study is planned as a prospective, cross-sectional study that will include patients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched.The study will be conducted on four groups. Group 1 (n=20; with mild symptoms), Group 2 (n=20; with moderate symptoms), Group 3 (n=20; with severe symptoms) and Group 4 (n=20; Control group).
All participants who accepted the study will have their sociodemographic data, medical history, and vital signs (respiratory rate, saturation, temperature, and blood pressure values) recorded at the start of the study. The pulmonologist in the study will also classify the patient group's chest X-ray and chest tomography findings and the thymus gland dimensions. After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis.
The study is planned as a prospective, cross-sectional study that will include patients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched. The study will be conducted on four groups.
Group 1 (n=20; with mild symptoms)
Group 2 (n=20; with moderate symptoms)
Group 3 (n=20; with severe symptoms)
Group 4 (n=20; Control group)
All participants who accepted the study will have their sociodemographic data, medical history, and vital signs (respiratory rate, saturation, temperature, and blood pressure values) recorded at the start of the study. The pulmonologist in the study will also classify the patient group's chest X-ray and chest tomography findings, as well as the thymus gland dimensions. After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1analysis. The sample will be centrifuged for around 5 minutes at 3000 rpm before being frozen at -70 degrees. The blood sample will be dissolved under proper conditions after a sufficient number of participants has been reached. The researchers will provide the ELISA kits for the study, and laboratory services will be purchased from outside the hospital. Due to Covid-19 disease, white blood cell, neutrophil, lymphocyte, and platelet counts, liver enzymes (AST, ALT, LDH), sodium, total protein, albumin, aPTT, PTZ, INR, D-Dimer, and fibrinogen levels will be recorded in the patient case report form, as well as CRP, IL-6, and ferritin levels, which are routinely requested from patients during their hospitalization. No treatment other than the treatments specified in the Covid-19 guidelines of the Ministry of Health will never be applied to the patients.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 80 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.
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Study population: patients who are 20 years of age and older, having Covid-19 PCR positivity in the nasopharyngeal swab and showing symptoms of Covid-19 (fever, cough, dyspnea, joint pain, etc.) with or without involvement in lung imaging. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched.
Exclusion Criteria:
Group 1 (n=20; with mild symptoms) * Covid positive patients with mild symptoms who required to be hospitalized, * Symptomatic (fever, cough, weakness, joint pain, etc.) new patients who apply to the Covid clinic for the first time, * Patients with stable vital signs and/or SpO2 ≥92% in room air, no radiological signs of lung involvement or mild pneumonia, * Patients who have not been started on steroid therapy and who have not yet received anticoagulant therapy.
Other: Serum PAI-1 alpha analysis.
Group 2 (n=20; with moderate symptoms) * Patients who are positive for Covid 19 and admitted to the covid clinic for the first time; * Radiologically moderate pneumonia findings and/or SpO2=88-92% in room air, * Patients who have not been started antiviral, steroid, and anticoagulant treatment.
Other: Serum PAI-1 alpha analysis.
Group 3 (n=20; with severe symptoms) * Patients who are currently hospitalized in the Covid clinic, * Patients with radiological findings of severe pneumonia or ARDS and/or high FiO2 requirement due to respiratory failure. * Patients of this group may have received antiviral, anticoagulant, and/or steroid and/or biologic agent treatment.
Other: Serum PAI-1 alpha analysis.
Group 4 (n=20; Control group) * The control group will be composed of healthy adult individuals applying to adult allergy outpatient clinics on a voluntary basis. * Patients who have not been previously diagnosed with Covid-19 and have not vaccinated against Covid-19, * The control patients will be matched with the study groups according to age, gender, and BMI.
Other: Serum PAI-1 alpha analysis.
After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis.
Serum PAI-1 levels of Covid-19 patients
To understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade.
Time frame: Blood sample collection is limited to up to 32 weeks and laboratory studies will be completed up to one week.
Serum PAI-1 levels of Covid-19 patients
To investigate PAI-1 utility in predicting disease prognosis.
Time frame: Up to 32 weeks for blood sample collection and up to one week for laboratory analysis.
Plan to share: Undecided
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Saglik Bilimleri Universitesi