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NCT04451577: UNICODE
Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection
trial testing No intervention in COVID in 5,000 participants. Status unknown.
1 June 2021
Quick facts
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 5,000 |
| Start date | 1 June 2020 |
| Primary completion | 1 June 2021 |
| Estimated completion | 1 June 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- No intervention
Conditions studied
- COVID — all drugs for COVID →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT04451577
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04451577 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Clinico Humanitas
- Last refreshed: 30 June 2020
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