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Active Monitoring And Determinants of Incidence Infection of COVDI-19

Sponsor
Fundación Teófilo Hernando, Spain (Other)
Overall Status
Unknown status
CT.gov ID
NCT04326400
Collaborator
(none)
1,000
Enrollment
1
Location
5.9
Anticipated Duration (Months)
168.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

  2. 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 .

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

  4. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol
    Actual Study Start Date :
    Mar 23, 2020
    Anticipated Primary Completion Date :
    Jul 20, 2020
    Anticipated Study Completion Date :
    Sep 20, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Hospital de la Princesa employees

    Outcome Measures

    Primary Outcome Measures

    1. COVID-19 App-based platform [6 months]

      The primary objective of this trial is to investigate whether the use of a cell phone App-based platform is a useful tool to monitor the symptoms of a population in risk of SARS-Cov2 infection. The final aim is to assess determinants of incidence of infection of COVID-19 in people working in Hospital during the pandemia of SARS-Cov-2.

    Secondary Outcome Measures

    1. COVID-19 infection [6 months]

      To monitor in real-time COVID-19 symptoms in the hospital workforce, which are a proxy of incident infection (Step 1) To identify in real-time clusters of COVID-19 symptoms and to facilitate control measures. To determine the incidence of new infection of COVID-19. To identify the determinants and risk/protective factors associated with this infection, in a workforce hospital population free of COVID-19 at the start of our study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    1. The subject belongs to the Hospital de La Princesa workforce.
    Exclusion Criteria:
    1. People with any symptom suspicious of COVID-19 infection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario de la Princesa Madrid Spain 28006

    Sponsors and Collaborators

    • Fundación Teófilo Hernando, Spain

    Investigators

    • Principal Investigator: Joan Soriano, MD, PhD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundación Teófilo Hernando, Spain
    ClinicalTrials.gov Identifier:
    NCT04326400
    Other Study ID Numbers:
    • AMADIICH
    First Posted:
    Mar 30, 2020
    Last Update Posted:
    Apr 1, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Coronavirus Infections

    Study Results

    No Results Posted as of Apr 1, 2020