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

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.

Study Overview

• Status: Unknown
• Conditions: Coronavirus Infection

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28006
    • Recruiting
    • Hospital Universitario de La Princesa
    • Contact: Joan Soriano, MD, PhD; Phone Number: +34 618867769; Email: jbsoriano2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hospital de la Princesa employees

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundación Teófilo Hernando, Spain
• Investigators: Principal Investigator: Joan Soriano, MD, PhD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Anticipated): July 20, 2020
• Study Completion (Anticipated): September 20, 2020

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Disease Attributes; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: AMADIICH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No