Coronavirus InfectionNCT04326400
Active Monitoring And Determinants of Incidence Infection of COVDI-19
An observational study of Coronavirus Infection, run by Fundación Teófilo Hernando, Spain at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 23 Mar 2020to 20 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Male or female subject age ≥ 18 years.
- The subject has no symptoms in last week of COVID-19 infection such as:
- Body temperature ≤ 37, 1 ºC.
- Normal lung and breath functions.
- The subject belongs to the Hospital de La Princesa workforce.
Who cannot join
- 1. People with any symptom suspicious of COVID-19 infection.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de la Princesa
Madrid, 28006
Joan Soriano, MD, PhD, +34 618867769, jbsoriano2@gmail.com
About this study
Official title: Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol
- Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population.
- 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 .
- Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks.
- 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.
- Conditions
- Coronavirus Infection
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospital de la Princesa employees | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start23 Mar 2020
- Primary completion20 Jul 2020 (estimated)
- Study completion20 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Teófilo Hernando, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joan Soriano, MD, PhD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326400
- Sponsor's protocol ID
- AMADIICH
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32845852
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol
- ClinicalTrials.gov ID
- NCT04326400
- Acronym / sponsor ID
- AMADIICH
- Conditions
- Coronavirus Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fundación Teófilo Hernando, SpainUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 20 Jul 2020 (estimated)
- Study completion
- 20 Sep 2020 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population.
- 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 .
- Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital de la Princesa employees | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Male or female subject age ≥ 18 years.
- The subject has no symptoms in last week of COVID-19 infection such as:
- The subject belongs to the Hospital de La Princesa workforce.
Key exclusion criteria (1 listed)
- 1. People with any symptom suspicious of COVID-19 infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
COVID-19 infection
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Derived from this study: PubMed 32845852Soriano 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.
Related trials for Coronavirus Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Soriano, MD, PhD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection, run by Fundación Teófilo Hernando, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Artuto García (+34 911 923 700, arturo.garcia@ifth.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 App-based platform (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.