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NCT04636203
Burden of COVID-19 Infection in Populations With High or Low Risk of Infection
trial in SARS-CoV-2 Infection in 4,000 participants. Completed in 31 December 2022.
15 September 2022
Quick facts
| Lead sponsor | Neuromed IRCCS |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 4,000 |
| Start date | 15 January 2020 |
| Primary completion | 15 September 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 2 locations across Italy |
Conditions studied
- SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →
- Covid19 — all drugs for Covid19 →
Sponsor
Neuromed IRCCS
Who can join
18 and older, any sex, with SARS-CoV-2 Infection or Covid19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Introduction. Some issues remain to be elucidated about SARS-CoV-2 infection to plan prevention interventions based on scientific evidence, such as the actual prevalence of infection including subclinical and seroconverted cases, the reasons for the different spread and severity of the infection in different subjects and geographical areas as well as the impact of the COVID-19 crisis on the health of healthcare professionals and in the general population. The aims of this project are: (i) to estimate and compare the real prevalence of the SARS-CoV-2 infection and seroconversion in two populations at high or low risk of infection,in Lombardia region and Molise region, respectively; focusing on subgroups at higher risk such as healthcare workers (HCWs); (ii) to estimate the incidence of burnout and post-traumatic stress disorder in HCWs; (iii) to identify factors associated with SARS-CoV-2 infection positivity and to follow up its mid-term effects on health. Methods. Participants will be randomly selected from the general population of both territories and from the HCWs list of the two healthcare facilities involved. SARS-CoV-2 IgG and IgM blood levels will be measured and anamnestic data will be collected through computerized tools. Prevalence of currently or previously infected subjects and their disease status and severity will be estimated and the association with potential risk factors will be analyzed through multivariable regression analyses. Expected results. The study will identify the burden of the infection in the general and HCWs populations. It will also identify the determinants of differences in the spread and severity of the infection, to hypothesize new preventive or therapeutic interventions. This study will provide a basis for monitoring the progress of the infection and its medium-term health consequences, Finally it will allow planning future studies, through analyses in biological samples which will be collected in dedicated biobanks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04636203
- 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 NCT04636203 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Neuromed IRCCS
- Last refreshed: 14 November 2023
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/NCT04636203.
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