Active Monitoring And Determinants of Incidence Infection of COVDI-19

NCT04326400 | Unknown

• 1 other identifier: AMADIICH
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

• COVID-19 App-based platform

  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.

  6 months

Secondary Outcomes (1)

• COVID-19 infection

  6 months

Study Arms (1)

Hospital de la Princesa employees

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in the maximum number of subjects willing to participate and able to understand and sign the informed consent form.

You may qualify if:

• Male or female subject age ≥ 18 years.
• The subject has no symptoms in last week of COVID-19 infection such as:
• Body temperature ≤ 37, 1 ºC.
• Normal lung and breath functions.
• The subject belongs to the Hospital de La Princesa workforce.

You may not qualify if:

• \. People with any symptom suspicious of COVID-19 infection.

Sponsors & Collaborators

• Fundación Teófilo Hernando, Spain: lead

Study Sites (1)

Hospital Universitario de la Princesa

Madrid, 28006, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 32845852 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Joan Soriano, MD, PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Artuto García

CONTACT

+34 911 923 700; arturo.garcia@ifth.es

Marcos Maroto

CONTACT

+34 911 923 700; marcos.maroto@ifth.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: March 23, 2020
• Primary Completion: July 20, 2020
• Study Completion: September 20, 2020
• Last Updated: April 1, 2020

Record last verified: 2020-03

Locations

ES (1)