Active Monitoring And Determinants of Incidence Infection of COVDI-19

NCT ID: NCT04326400

Last Updated: 2020-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-23

Study Completion Date

2020-09-20

Brief Summary

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7\. Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population.

8\. Study design Prospective, Single-centre, observational clinical study. 9. Disease or disorder under study Healthy people in risk of COVID-19 infection. 10. Main variable. Symptoms related to infection caused by SARS-Cov2. 11. Study population and total number of patients Men and women in general god health status aged between 18 and 80 years that currently are employees of Hospital de La Princesa .

12\. Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks.

13\. Timetable and expected date of completion The overall duration of the study is estimated at about 6 months, from patient recruitment to the last data recorded by last subject. The aim is to carry out this study from March 2020 onwards.

Detailed Description

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Conditions

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Coronavirus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hospital de la Princesa employees

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male or female subject age ≥ 18 years.
2. The subject has no symptoms in last week of COVID-19 infection such as:

* Body temperature ≤ 37, 1 ºC.
* Normal lung and breath functions.
3. The subject belongs to the Hospital de La Princesa workforce.

Exclusion Criteria

1\. People with any symptom suspicious of COVID-19 infection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Teófilo Hernando, Spain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joan Soriano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Locations

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Hospital Universitario de la Princesa

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Artuto García

Role: CONTACT

+34 911 923 700

Marcos Maroto

Role: CONTACT

+34 911 923 700

Facility Contacts

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Joan Soriano, MD, PhD

Role: primary

+34 618867769

References

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Soriano JB, Fernandez E, de Astorza A, Perez de Llano LA, Fernandez-Villar A, Carnicer-Pont D, Alcazar-Navarrete B, Garcia A, Morales A, Lobo M, Maroto M, Ferreras E, Soriano C, Del Rio-Bermudez C, Vega-Piris L, Basagana X, Muncunill J, Cosio BG, Lumbreras S, Catalina C, Alzaga JM, Gomez Quilon D, Valdivia CA, de Lara C, Ancochea J. Hospital Epidemics Tracker (HEpiTracker): Description and pilot study of a mobile app to track COVID-19 in hospital workers. JMIR Public Health Surveill. 2020 Sep 21;6(3):e21653. doi: 10.2196/21653.

Reference Type DERIVED
PMID: 32845852 (View on PubMed)

Other Identifiers

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AMADIICH

Identifier Type: -

Identifier Source: org_study_id

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