Infection Viral Clinical Trial
— IMMUNOVIDOfficial title:
Evaluation of Immune Response in COVID-19 Patients
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | November 26, 2020 |
Est. primary completion date | June 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Universitaria Integrata Verona | Verona |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Integrata Verona |
Italy,
Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. — View Citation
Merad M, Martin JC. Pathological inflammation in patients with COVID-19: a key role for monocytes and macrophages. Nat Rev Immunol. 2020 Jun;20(6):355-362. doi: 10.1038/s41577-020-0331-4. Epub 2020 May 6. Review. Erratum in: Nat Rev Immunol. 2020 Jun 2;:. — View Citation
Moore JB, June CH. Cytokine release syndrome in severe COVID-19. Science. 2020 May 1;368(6490):473-474. doi: 10.1126/science.abb8925. Epub 2020 Apr 17. — View Citation
Tay MZ, Poh CM, Rénia L, MacAry PA, Ng LFP. The trinity of COVID-19: immunity, inflammation and intervention. Nat Rev Immunol. 2020 Jun;20(6):363-374. doi: 10.1038/s41577-020-0311-8. Epub 2020 Apr 28. Review. — View Citation
Wen W, Su W, Tang H, Le W, Zhang X, Zheng Y, Liu X, Xie L, Li J, Ye J, Dong L, Cui X, Miao Y, Wang D, Dong J, Xiao C, Chen W, Wang H. Immune cell profiling of COVID-19 patients in the recovery stage by single-cell sequencing. Cell Discov. 2020 May 4;6:31. doi: 10.1038/s41421-020-0168-9. eCollection 2020. — View Citation
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | COVID-19 associated immune disorder | Enumeration of circulating cell subsets by flow cytometry [Cell count/µl] | 24 hours | |
Primary | COVID-19 associated inflammation | Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-?, IFN-a, 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-3a/CCL20, CCL2, TNF-a, TNF-ß, TGFß) [pg/ml] | 48 hours | |
Primary | Oxygenation | Ratio of arterial oxygen tension (mmHg) to fraction of inspired oxygen (PaO2/FiO2) | 24 hours | |
Primary | Diagnostic of COVID disease composite | SARS-CoV-2 infection will be tested by PCR using nasopharyngeal swab | On admission of hospital | |
Secondary | Changes at the cytokine pattern | Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-?, IFN-a, 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-3a/CCL20, CCL2, TNF-a, TNF-ß, TGFß) [pg/ml] | 14 Days | |
Secondary | Changes at circulating immune cell composition | Enumeration of circulating cell subsets by flow cytometry [Cell count/µl] | 14 Days | |
Secondary | Intensive Care Unit Admission | Proportion of patients with Intensive Care Unit Admission requirement | Day 7-14 | |
Secondary | Length of hospital stay | Days of Hospitalization | Day 7-14 | |
Secondary | Clinical Status | Clinical status assessed according to the World Health Organization guideline | Day 7-14 | |
Secondary | Mortality | Proportion of death patients at days | Day 7-14 |
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