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The Role of Ischemia Modified Albumin in Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT05286268
Recruitment Status : Recruiting
First Posted : March 18, 2022
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Pagonis Athanasios, Larissa University Hospital

Brief Summary:

The purpose of the study is to recognize the diagnostic and/or prognostic value of IMA, as It reflects the degree of ischemia regardless of the affected organ.

Our sample, which will be taken from the Pulmonology/Covid-19 Department and the Outpatient Clinic of the Pulmonology Department of University Hospital of Larissa, will be divided into two groups. The first group will be the study group, which will include patients with confirmed COVID-19 infection, while the second group will be the control group, which will include healthy volunteers. From the study population will be collected demographics, medical history, medication, symptoms, vital points, arterial blood gases, viral load from RT-PCR for SARS-COV2 and findings from imaging and laboratory assessment. On a daily basis, during their treatment, their vital points, their laboratory tests and the presence of possible complications will be recorded.

Expected results are: 1) Comparison of IMA levels between COVID-19 patients and healthy volunteers, 2) The IMA contribution, during their admission to the hospital, to the prediction of the risk of deterioration and severe respiratory failure, 3) The increase of the predictive accuracy of SuPAR as a risk stratification biomarker, after its combination with IMA, 4) The estimation of IMA on the 10th day of illness in patients with severe respiratory failure, 5) The possibility of predicting with greater accuracy the probability of admission to the ICU, by measuring the IMA on the 10th day of illness compared to the IMA of admission.


Condition or disease Intervention/treatment
COVID-19 Diagnostic Test: Ischemia Modified Albumin

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 194 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Ischemia Modified Albumin in Patients With COVID-19
Actual Study Start Date : April 6, 2022
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Plasminogen

Group/Cohort Intervention/treatment
Study group
Patients with confirmed COVID-19 disease
Diagnostic Test: Ischemia Modified Albumin
Blood sampling at admission for measurement of IMA and suPAR levels and at day 10 from symptom onset (peak of symptoms) for IMA level. Samples will be collected in blood collection tubes containing K2EDTA as anticoagulant and serum separation gel tubes for SuPAR and IMA assays respectively. The samples will be centrifuged (at 3000 x g for 10 minutes) within the first 3 hours of sampling. Then, both plasma and serum samples will be placed in Eppendorf tubes and stored at -80oC. IMA levels will be determined according to the principles of the ACB assay, using the commercially available "Ischemia Modified Albumin Assay Kit" method (Abbexa LTD, Cambridge, UK), on the Architect c8000 automatic analytical system (Abbott, USA). SuPAR levels will be determined by the suPARnostic TurbiLatex quantitative turbidimetric immunoassay (ViroGates A/S, Denmark), also on the Architect c8000 automatic analytical system.
Other Name: Soluble Urokinase Plasminogen Activator Receptor

Control group
Healthy volunteers without any of the exclusion criteria
Diagnostic Test: Ischemia Modified Albumin
Blood sampling at admission for measurement of IMA and suPAR levels and at day 10 from symptom onset (peak of symptoms) for IMA level. Samples will be collected in blood collection tubes containing K2EDTA as anticoagulant and serum separation gel tubes for SuPAR and IMA assays respectively. The samples will be centrifuged (at 3000 x g for 10 minutes) within the first 3 hours of sampling. Then, both plasma and serum samples will be placed in Eppendorf tubes and stored at -80oC. IMA levels will be determined according to the principles of the ACB assay, using the commercially available "Ischemia Modified Albumin Assay Kit" method (Abbexa LTD, Cambridge, UK), on the Architect c8000 automatic analytical system (Abbott, USA). SuPAR levels will be determined by the suPARnostic TurbiLatex quantitative turbidimetric immunoassay (ViroGates A/S, Denmark), also on the Architect c8000 automatic analytical system.
Other Name: Soluble Urokinase Plasminogen Activator Receptor




Primary Outcome Measures :
  1. Hospitalization outcome [ Time Frame: Up to 8 weeks ]
    Admission to ICU, death, discharge


Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Consecutive adult patients who are admitted to the Hospital due to Covid-19
Criteria

Inclusion Criteria:

  • > 18 years old
  • Positive nasopharyngeal test for SARS-CoV-2 confirmed by RT-PCR

Exclusion Criteria:

  • Age < 18 years old
  • SARS-CoV-2 infection not confirmed by RT PCR
  • No consent for participation in the study
  • Acute ischemic disease prior to SARS-CoV-2 (trauma, mesenteric ischemia, stroke, liver disease, venous thromboembolic disease, acute coronary syndrome in the last 3 months, etc.)
  • Pregnancy
  • Immunosuppression
  • Albumin < 2gr/dl or > 5.5gr/dl

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05286268


Contacts
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Contact: Athanasios D. Pagonis, Resident (+30) 6982925353 thanos.pgns@gmail.com
Contact: Ioannis N. Pantazopoulos, Professor (+30) 6945661525 pantazopoulosioannis@yahoo.com

Locations
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Greece
Larissa University Hospital Recruiting
Larissa, Thessalia, Greece, 41334
Contact: Athanasios D. Pagonis, Resident    6982925353 ext (+30)    thanos.pgns@gmail.com   
Contact: Ioannis N. Pantazopoulos, Professor    6945661525 ext (+30)    pantazopoulosioannis@yahoo.com   
Sponsors and Collaborators
Larissa University Hospital
Investigators
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Principal Investigator: Athanasios D. Pagonis, Resident University Hospital of Larissa, Pulmonology Department
Publications:

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Responsible Party: Pagonis Athanasios, Pulmonology resident, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT05286268    
Other Study ID Numbers: 24918
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pagonis Athanasios, Larissa University Hospital:
COVID-19
SARS-CoV-2
Ischemia Modified Albumin
IMA
Prognosis
Additional relevant MeSH terms:
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COVID-19
Ischemia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action