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Active Monitoring And Determinants of Incidence Infection of COVDI-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326400
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Coronavirus Infection

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : September 20, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Hospital de la Princesa employees



Primary Outcome Measures :
  1. COVID-19 App-based platform [ Time Frame: 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 :
  1. COVID-19 infection [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326400


Contacts
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Contact: Artuto García +34 911 923 700 arturo.garcia@ifth.es
Contact: Marcos Maroto +34 911 923 700 marcos.maroto@ifth.es

Locations
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Spain
Hospital Universitario de la Princesa Recruiting
Madrid, Spain, 28006
Contact: Joan Soriano, MD, PhD    +34 618867769    jbsoriano2@gmail.com   
Sponsors and Collaborators
Fundación Teófilo Hernando, Spain
Investigators
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Principal Investigator: Joan Soriano, MD, PhD Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundación Teófilo Hernando, Spain
ClinicalTrials.gov Identifier: NCT04326400    
Other Study ID Numbers: AMADIICH
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases