Annexin A1 Levels in SARS-CoV-2 Infection

NCT04948229 | Completed

• 1 other identifier: Clinical-5
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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 Venous blood samples that will be taken when the patients were admitted to ED were withdrawn into a dry test tube that did not contain anti-coagulant and were then centrifugated for 10 minutes at 4000 rpm.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

Conditions

Annexin A1; Adrenal Cortex Hormones

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To determine differences between moderate and severe/critical disease groups in terms of serum Annexin A1 levels.

  17 days

Study Arms (3)

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

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

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

Interventions

Blood serum samples OTHER

Blood serum samples will be taken.

Control Group; Moderate Disease Group; Severe/Critical Disease Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• To have any known disease
• To use any drugs Moderate Disease Group
• To have confirmed COVID-19 infection
• To have positive RT-PCR in ED according to WHO guidelines
• To give informed consent.
• 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
• To have confirmed severe/critical COVID-19 infection
• To have positive RT-PCR in ED according to WHO guidelines
• To give informed consent.
• To have any heart, kidney or liver failure
• To have acute pulmonary embolism

Sponsors & Collaborators

• Kafkas University: lead
• Aylin Koseler: collaborator

Study Sites (1)

Ramazan Sabirli

Kars, Outside of the US, 36000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum analysis will be done.

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 1, 2021
• Study Start: February 10, 2021
• Primary Completion: March 15, 2021
• Study Completion: March 16, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)