NCT04438629

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2020

Completed
Last Updated

June 22, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

June 16, 2020

Last Update Submit

June 18, 2020

Conditions

Allergy and ImmunologyInfection Viral

Keywords

COVID-19IMMUNE SYSTEMINNATE IMMUNITYADAPTIVE IMMUNITY

Outcome Measures

Primary Outcomes (4)

  • COVID-19 associated immune disorder

    Enumeration of circulating cell subsets by flow cytometry \[Cell count/µl\]

    24 hours

  • COVID-19 associated inflammation

    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) \[pg/ml\]

    48 hours

  • Oxygenation

    Ratio of arterial oxygen tension (mmHg) to fraction of inspired oxygen (PaO2/FiO2)

    24 hours

  • Diagnostic of COVID disease composite

    SARS-CoV-2 infection will be tested by PCR using nasopharyngeal swab

    On admission of hospital

Secondary Outcomes (6)

  • Changes at the cytokine pattern

    14 Days

  • Changes at circulating immune cell composition

    14 Days

  • Intensive Care Unit Admission

    Day 7-14

  • Length of hospital stay

    Day 7-14

  • Clinical Status

    Day 7-14

  • +1 more secondary outcomes

Study Arms (3)

Mild disease

COVID-19 hospitalized patients

Drug: COVID-19 treatment

Severe disease

COVID-19 hospitalized patients in intensive care unit

Drug: COVID-19 treatment

paucisymptomatic syndrome

Mild symptomatic patients in home quarantine

Drug: COVID-19 treatment

Interventions

COVID-19 treatmentDRUG

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.

Mild diseaseSevere diseasepaucisymptomatic syndrome

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized adults affected by SARS-CoV-2.

You may qualify if:

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

You may not qualify if:

  • Patients that withdraw informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

RECRUITING

Related Publications (7)

  • 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. No abstract available.

    PMID: 32303591BACKGROUND

  • 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. No abstract available.

    PMID: 32192578BACKGROUND

  • Tay MZ, Poh CM, Renia 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.

    PMID: 32346093BACKGROUND

  • 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.

    PMID: 32377375BACKGROUND

  • 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.

    PMID: 32376901BACKGROUND

  • 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.

    PMID: 32171076BACKGROUND

  • Bronte V, Ugel S, Tinazzi E, Vella A, De Sanctis F, Cane S, Batani V, Trovato R, Fiore A, Petrova V, Hofer F, Barouni RM, Musiu C, Caligola S, Pinton L, Torroni L, Polati E, Donadello K, Friso S, Pizzolo F, Iezzi M, Facciotti F, Pelicci PG, Righetti D, Bazzoni P, Rampudda M, Comel A, Mosaner W, Lunardi C, Olivieri O. Baricitinib restrains the immune dysregulation in patients with severe COVID-19. J Clin Invest. 2020 Dec 1;130(12):6409-6416. doi: 10.1172/JCI141772.

    PMID: 32809969DERIVED

MeSH Terms

Conditions

HypersensitivityVirus DiseasesCOVID-19

Interventions

COVID-19 Drug Treatment

Condition Hierarchy (Ancestors)

Immune System DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • VINCENZO BRONTE, MD

    University and Hospital Trust of Verona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

STEFANO UGEL

CONTACT

0458126451stefano.ugel@univr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 19, 2020

Study Start

March 26, 2020

Primary Completion

June 10, 2020

Study Completion

November 26, 2020

Last Updated

June 22, 2020

Record last verified: 2020-03

Locations

IT(1)