Evaluation of Immune Response in COVID-19 Patients (IMMUNOVID)
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ClinicalTrials.gov Identifier: NCT04438629 |
Recruitment Status : Unknown
Verified March 2020 by Azienda Ospedaliera Universitaria Integrata Verona.
Recruitment status was: Recruiting
First Posted : June 19, 2020
Last Update Posted : June 22, 2020
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Condition or disease | Intervention/treatment |
---|---|
Allergy and Immunology Infection Viral | Drug: COVID-19 treatment |

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
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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
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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
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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. |
- COVID-19 associated immune disorder [ Time Frame: 24 hours ]Enumeration of circulating cell subsets by flow cytometry [Cell count/µl]
- 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]
- Oxygenation [ Time Frame: 24 hours ]Ratio of arterial oxygen tension (mmHg) to fraction of inspired oxygen (PaO2/FiO2)
- Diagnostic of COVID disease composite [ Time Frame: On admission of hospital ]SARS-CoV-2 infection will be tested by PCR using nasopharyngeal swab
- 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]
- Changes at circulating immune cell composition [ Time Frame: 14 Days ]Enumeration of circulating cell subsets by flow cytometry [Cell count/µl]
- Intensive Care Unit Admission [ Time Frame: Day 7-14 ]Proportion of patients with Intensive Care Unit Admission requirement
- Length of hospital stay [ Time Frame: Day 7-14 ]Days of Hospitalization
- Clinical Status [ Time Frame: Day 7-14 ]Clinical status assessed according to the World Health Organization guideline
- Mortality [ Time Frame: Day 7-14 ]Proportion of death patients at days

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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 |
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

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
Contact: STEFANO UGEL | 0458126451 ext 0039 | stefano.ugel@univr.it |
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 |
Principal Investigator: | VINCENZO BRONTE, MD | University and Hospital Trust of Verona |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 IMMUNE SYSTEM INNATE IMMUNITY ADAPTIVE IMMUNITY |
COVID-19 Virus Diseases Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |