Active Monitoring And Determinants of Incidence Infection of COVDI-19

• Conditions: Coronavirus Infection

• Registration Number: NCT04326400
• Lead Sponsor: Fundación Teófilo Hernando, Spain

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-23
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-30
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01
• Primary Completion: 2020-07-20
• Study Completion: 2020-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain