Last reviewed · How we verify

NCT04451577: UNICODE

Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection

Status unknown Last updated 30 June 2020
What this trial tests

trial testing No intervention in COVID in 5,000 participants. Status unknown.

Timeline
1 June 2020
Primary endpoint
1 June 2021
1 June 2023

Quick facts

Lead sponsorIstituto Clinico Humanitas
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment5,000
Start date1 June 2020
Primary completion1 June 2021
Estimated completion1 June 2023
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituto Clinico Humanitas

Who can join

18 and older, any sex, with COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts. Participants will be asked consent for the research use of blood, pharyngeal swab, and for those hospitalized for COVID-19, also for the bronchoalveolar lavage and fecal samples. Biological samples will be used to perform cellular, microbial and molecular analyses aimed at better understanding the disease pathogenesis and the individual differences in susceptibility to the disease.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Role of Gut Microbiome in COVID-19: An Insight Into Pathogenesis and Therapeutic Potential.
    Hussain I, Cher GLY, Abid MA, Abid MB. · · 2021 · cited 53× · PMID 34721437 · DOI 10.3389/fimmu.2021.765965
  2. Gut Microbiota Dysbiosis-Immune Hyperresponse-Inflammation Triad in Coronavirus Disease 2019 (COVID-19): Impact of Pharmacological and Nutraceutical Approaches.
    Ferreira C, Viana SD, Reis F. · · 2020 · cited 44× · PMID 33019592 · DOI 10.3390/microorganisms8101514
  3. BNT162b2 vaccine induces antibody release in saliva: a possible role for mucosal viral protection?
    Darwich A, Pozzi C, Fornasa G, Lizier M, et al · · 2022 · cited 32× · PMID 35393790 · DOI 10.15252/emmm.202115326
  4. A 'Multiomic' Approach of Saliva Metabolomics, Microbiota, and Serum Biomarkers to Assess the Need of Hospitalization in Coronavirus Disease 2019.
    Pozzi C, Levi R, Braga D, Carli F, et al · · 2022 · cited 18× · PMID 35174369 · DOI 10.1016/j.gastha.2021.12.006

Verify or expand the search:

Other trials of No intervention

Trials testing the same drug.

Other recruiting trials for COVID

Currently open trials in the same condition.

Other Istituto Clinico Humanitas trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04451577.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing