Annexin A1 Levels in SARS-CoV-2 Infection

Study Overview
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Brief Summary
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The present study aims to determine the clinical predictivity value of blood AnxA1 levels in patients with mild and severe/critical pneumonia induced by COVID-19 and to reveal the alterations of blood AnxA1 levels in patients with pneumonia compared to the control group.The present study is a prospective case-control study, and the required ethics approval was obtained from the Ethics Committee of Pamukkale University (Numbered: E-60116787-020-15062). The study was conducted at Ankara Training and Research Hospital between 10.02.2021 and 15.03.2021. All procedures will carried out on patients were in compliance with the Helsinki Declaration.Study groups were established according to the inclusion and exclusion criteria. Patients whose diagnoses were clinically confirmed as COVID-19 infection according to World Health Organization (WHO) guidelines using a positive reverse transcriptase polymerase chain reaction (RT-PCR) test will be included in the study (15). Individuals will be grouped in the moderate COVID-19 disease group (N=42), severe/critical COVID-19 disease group (N=32), and the healthy control group (N=50). Healthy group will be included subjects who had no history or diagnosis of any disease, no infection history within last two weeks, no history of any particular medication, who were admitted to emergency department (ED) with complaints other than infectious issues, and who gave their written consent to participate in the study. Venous blood samples that will be taken when the patients were admitted to ED were withdrawn into a dry test tube that did not contain anti-coagulant and were then centrifugated for 10 minutes at 4000 rpm. Serum samples will be obtained from centrifugation were collected for laboratory analysis. Serum AnxA1 levels were analyzed using a commercially available AnxA1 ELISA Kit (Elabscience, E-EL-H5512, USA), per the manufacturer's protocol.

Detailed Description
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The present study aims to determine the clinical predictivity value of blood AnxA1 levels in patients with mild and severe/critical pneumonia induced by COVID-19 and to reveal the alterations of blood AnxA1 levels in patients with pneumonia compared to the control group.The present study is a prospective case-control study, and the required ethics approval was obtained from the Ethics Committee of Pamukkale University (Numbered: E-60116787-020-15062). The study was conducted at Ankara Training and Research Hospital between 10.02.2021 and 15.03.2021. All procedures will carried out on patients were in compliance with the Helsinki Declaration.Study groups were established according to the inclusion and exclusion criteria. Patients whose diagnoses were clinically confirmed as COVID-19 infection according to World Health Organization (WHO) guidelines using a positive reverse transcriptase polymerase chain reaction (RT-PCR) test will be included in the study (15). Individuals will be grouped in the moderate COVID-19 disease group (N=42), severe/critical COVID-19 disease group (N=32), and the healthy control group (N=50). Healthy group will be included subjects who had no history or diagnosis of any disease, no infection history within last two weeks, no history of any particular medication, who were admitted to emergency department (ED) with complaints other than infectious issues, and who gave their written consent to participate in the study. Venous blood samples that will be taken when the patients were admitted to ED were withdrawn into a dry test tube that did not contain anti-coagulant and were then centrifugated for 10 minutes at 4000 rpm. Serum samples will be obtained from centrifugation were collected for laboratory analysis. Serum AnxA1 levels were analyzed using a commercially available AnxA1 ELISA Kit (Elabscience, E-EL-H5512, USA), per the manufacturer's protocol. Inclusion Criteria Patient Groups: Patients whose diagnoses of COVID-19 infection were confirmed by positive RT-PCR in ED according to WHO guidelines and who gave their written consent were included in the study (15). Control Group: Subjects with no history of a known disease, no infectious symptoms, no drug use, and who provided written consent were included in the study.

Official Title
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Annexin A1 as a Potential Prognostic Biomarker for COVID-19 Disease: Case-Control Study

Conditions
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Annexin A1, Adrenal Cortex Hormones

Intervention / Treatment
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* Other: Blood serum samples


Participation Criteria
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Eligibility Criteria
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Healthy Group Inclusion Criteria: Not to have any known disease Not to use any drugs Not to have any history of chronic disease and infection Not to have any infectious symptoms To give informed consent. Exclusion Criteria: To have any known disease To use any drugs Moderate Disease Group Inclusion Criteria: To have confirmed COVID-19 infection To have positive RT-PCR in ED according to WHO guidelines To give informed consent. Exclusion Criteria: To have any heart, kidney or liver failure To have acute pulmonary embolism To have deep venous thrombosis or chronic inflammatory disease To have pregnancy Severe/Critical Disease Group Inclusion Criteria: To have confirmed severe/critical COVID-19 infection To have positive RT-PCR in ED according to WHO guidelines To give informed consent. Exclusion Criteria: To have any heart, kidney or liver failure To have acute pulmonary embolism To have deep venous thrombosis or chronic inflammatory disease To have pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>This group will be included subjects who had no history or diagnosis of any disease, no infection history within last two weeks, no history of any particular medication, who were admitted to emergency department (ED) with complaints other than infectious issues, and who gave their written consent to participate in the study. | Other: Blood serum samples<br>* Blood serum samples will be taken.<br>|
| Moderate Disease Group<br>This group will be consisted of the patients whose diagnoses of moderate COVID-19 infection were confirmed by positive RT-PCR in ED according to WHO guidelines and who gave their written consent were included in the study. | Other: Blood serum samples<br>* Blood serum samples will be taken.<br>|
| Severe/Critical Disease Group<br>This group will be consisted of the patients whose diagnoses of severe/critical COVID-19 infection were confirmed by positive RT-PCR in ED according to WHO guidelines and who gave their written consent were included in the study. | Other: Blood serum samples<br>* Blood serum samples will be taken.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine differences between controls and patients groups in terms of serum Annexin A1 levels | Serum annexin A1 levels will be analysed statistically and the differences will be determined between the patients and controls. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine differences between moderate and severe/critical disease groups in terms of serum Annexin A1 levels. | Serum annexin A1 levels will be analysed statistically and the differences will be determined between the moderate and severe/critical disease group | 17 days |