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Evaluation of Immune Response in COVID-19 Patients (IMMUNOVID)

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ClinicalTrials.gov Identifier: NCT04438629
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary:
The aim of the project is to evaluate the immunological features of COVID-19 patients. Patients are recruited without any pharmacological treatments restriction. The number of samples is estimated on the basis of feasibility, that means on the maximum number of patients with COVID-19, who are expected to be able to be enrolled by the units involved. Based on the investigators' experience, gained in the onco-immunological field, considering the time and economic resources available, the investigators expect to enroll at least 80 patients.

Condition or disease Intervention/treatment
Allergy and Immunology Infection Viral Drug: COVID-19 treatment

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Immune Response in COVID-19 Patients
Actual Study Start Date : March 26, 2020
Actual Primary Completion Date : June 10, 2020
Estimated Study Completion Date : November 26, 2020

Group/Cohort Intervention/treatment
Mild disease
COVID-19 hospitalized patients
Drug: COVID-19 treatment
COVID-19 affected patients treated with hydroxicloroquine or antiviral therapy (lopinavir/ritonavir) as single agents or in combination (hydroxicloroquine plus antiviral therapy) according to clinical features. Other concomitant treatments (i.e. off-label therapy) will be provided at the discretion of clinicians. Supportive therapy, such as antibiotic prophylaxis and anticoagulant treatment, will be provided at the discretion of the clinicians.

Severe disease
COVID-19 hospitalized patients in intensive care unit
Drug: COVID-19 treatment
COVID-19 affected patients treated with hydroxicloroquine or antiviral therapy (lopinavir/ritonavir) as single agents or in combination (hydroxicloroquine plus antiviral therapy) according to clinical features. Other concomitant treatments (i.e. off-label therapy) will be provided at the discretion of clinicians. Supportive therapy, such as antibiotic prophylaxis and anticoagulant treatment, will be provided at the discretion of the clinicians.

paucisymptomatic syndrome
Mild symptomatic patients in home quarantine
Drug: COVID-19 treatment
COVID-19 affected patients treated with hydroxicloroquine or antiviral therapy (lopinavir/ritonavir) as single agents or in combination (hydroxicloroquine plus antiviral therapy) according to clinical features. Other concomitant treatments (i.e. off-label therapy) will be provided at the discretion of clinicians. Supportive therapy, such as antibiotic prophylaxis and anticoagulant treatment, will be provided at the discretion of the clinicians.




Primary Outcome Measures :
  1. COVID-19 associated immune disorder [ Time Frame: 24 hours ]
    Enumeration of circulating cell subsets by flow cytometry [Cell count/µl]

  2. COVID-19 associated inflammation [ Time Frame: 48 hours ]
    Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-γ, IFN-α, IL-1, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, IL-34, MIP-3α/CCL20, CCL2, TNF-α, TNF-β, TGFβ) [pg/ml]

  3. Oxygenation [ Time Frame: 24 hours ]
    Ratio of arterial oxygen tension (mmHg) to fraction of inspired oxygen (PaO2/FiO2)

  4. Diagnostic of COVID disease composite [ Time Frame: On admission of hospital ]
    SARS-CoV-2 infection will be tested by PCR using nasopharyngeal swab


Secondary Outcome Measures :
  1. Changes at the cytokine pattern [ Time Frame: 14 Days ]
    Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-γ, IFN-α, IL-1, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, IL-34, MIP-3α/CCL20, CCL2, TNF-α, TNF-β, TGFβ) [pg/ml]

  2. Changes at circulating immune cell composition [ Time Frame: 14 Days ]
    Enumeration of circulating cell subsets by flow cytometry [Cell count/µl]

  3. Intensive Care Unit Admission [ Time Frame: Day 7-14 ]
    Proportion of patients with Intensive Care Unit Admission requirement

  4. Length of hospital stay [ Time Frame: Day 7-14 ]
    Days of Hospitalization

  5. Clinical Status [ Time Frame: Day 7-14 ]
    Clinical status assessed according to the World Health Organization guideline

  6. Mortality [ Time Frame: Day 7-14 ]
    Proportion of death patients at days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized adults affected by SARS-CoV-2.
Criteria

Inclusion Criteria:

  • Hospitalized adults affected by SARS-CoV-2. These patients can be enrolled also for other clinical studies such as off-label or compassionate treatments.

Exclusion Criteria:

  • Patients that withdraw informed consent

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): NCT04438629


Contacts
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Contact: STEFANO UGEL 0458126451 ext 0039 stefano.ugel@univr.it

Locations
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Italy
Azienda Ospedaliera Universitaria Integrata Verona Recruiting
Verona, Italy, 37126
Contact: STEFANO UGEL    0458126451 ext 0039    stefano.ugel@univr.it   
Principal Investigator: VINCENZO BRONTE, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Investigators
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Principal Investigator: VINCENZO BRONTE, MD University and Hospital Trust of Verona
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT04438629    
Other Study ID Numbers: IMMUNOVID 2590CESC
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: March 2020

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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 Azienda Ospedaliera Universitaria Integrata Verona:
COVID-19
IMMUNE SYSTEM
INNATE IMMUNITY
ADAPTIVE IMMUNITY
Additional relevant MeSH terms:
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Virus Diseases