Annexin A1 Levels in SARS-CoV-2 Infection

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

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Venous blood samples that will be taken when the patients were admitted to ED were withdrawn into a dry test tube that did not contain anti-coagulant and were then centrifugated for 10 minutes at 4000 rpm.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.

Study Overview

• Status: Completed
• Conditions: Annexin A1; Adrenal Cortex Hormones
• Intervention / Treatment: Other: Blood serum samples

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Turkey
  • Outside Of The US
    • Kars, Outside Of The US, Turkey, 36000
      • Ramazan Sabirli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The subjects will be included in the present study were clinically evaluated using WHO diagnosis and treatment guidelines for COVID-19. The patient management algorithms will be administered due to the updates of these guidelines. The patient groups will be categorized as moderate disease and severe/critical disease according to WHO guidelines. 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; 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; Blood serum samples will be taken.
Moderate Disease Group; 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; Blood serum samples will be taken.
Severe/Critical Disease Group; 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; Blood serum samples will be taken.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kafkas University
• Collaborators: Aylin Koseler

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): March 16, 2021

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Clinical-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No