Annexin A1NCT04948229
Annexin A1 Levels in SARS-CoV-2 Infection
An observational study of Annexin A1 and Adrenal Cortex Hormones, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Annexin A1, Adrenal Cortex Hormones
- What is being tested?
- Blood serum samples
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2021to 16 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
- To have confirmed COVID-19 infection
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- To have positive RT-PCR in ED according to WHO guidelines
- To give informed consent.
- To have confirmed severe/critical COVID-19 infection
- To have positive RT-PCR in ED according to WHO guidelines
- To give informed consent.
Who cannot join
- To have any known disease
- To use any drugs Moderate Disease Group
- 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
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- Severe/Critical Disease Group
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ramazan Sabirli
Kars, Outside of the US, 36000
About this study
Official title: 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.
Read the 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.
- Conditions
- Annexin A1, Adrenal Cortex Hormones
- Being tested
- Blood serum samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood serum samplesOther
Blood serum samples will be taken.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Blood serum samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Secondary outcomes (1)
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
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start10 Feb 2021
- Primary completion15 Mar 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Annexin A1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Collaborators
- Aylin Koseler
- Responsible party
- Principal investigator, Ramazan Sbirli, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948229
- Sponsor's protocol ID
- Clinical-5
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Annexin A1 as a Potential Prognostic Biomarker for COVID-19 Disease: Case-Control Study
- ClinicalTrials.gov ID
- NCT04948229
- Acronym / sponsor ID
- Clinical-5
- Conditions
- Annexin A1, Adrenal Cortex Hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Collaborators
- Aylin Koseler
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: Blood serum samplesThis 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. |
| Moderate Disease Group | – | Other: Blood serum samplesThis 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. |
| Severe/Critical Disease Group | – | Other: Blood serum samplesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- To have any known disease
- To use any drugs Moderate Disease Group
- To have any heart, kidney or liver failure
- To have acute pulmonary embolism
- To have deep venous thrombosis or chronic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood serum samplesBlood serum samples will be taken. | Other | Control Group, Moderate Disease Group, Severe/Critical Disease Group |
Primary outcome
To determine differences between controls and patients groups in terms of serum Annexin A1 levels
Time frame: 15 days
Serum annexin A1 levels will be analysed statistically and the differences will be determined between the patients and controls.
1 secondary outcome
To determine differences between moderate and severe/critical disease groups in terms of serum Annexin A1 levels.
Time frame: 17 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Annexin A1 and Adrenal Cortex Hormones, run by Kafkas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine differences between controls and patients groups in terms of serum Annexin A1 levels (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.