Active Monitoring And Determinants of Incidence Infection of COVDI-19

Coronavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04326400
• Other study ID #: AMADIICH
• Status: Recruiting
• Start date: March 23, 2020
• Est. completion date: September 20, 2020

Study information

• Verified date: March 2020
• Source: Fundación Teófilo Hernando, Spain
• Contact: Artuto García
• Phone: +34 911 923 700
• Email: arturo.garcia[@]ifth.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 20, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
Spain	Hospital Universitario de la Princesa	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Teófilo Hernando, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	COVID-19 infection	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.	6 months