Active Monitoring And Determinants of Incidence Infection of COVDI-19

Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04326400

Enrollment

1000

Registered

2020-03-30

Start date

2020-03-23

Completion date

2020-09-20

Last updated

2020-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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. 3. The subject belongs to the Hospital de La Princesa workforce.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Contacts

Primary ContactArtuto García

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

Backup ContactMarcos Maroto

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

Outcome results