SARS-CoV-2 InfectionNCT04466462
Cross-sectional Study of COVID-19 Infection in Hospital Health Personnel
An observational study of SARS-CoV-2 Infection, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 2 sites in Spain.
Trial summary
The objective of the study is to determine the percentage of past SARS-CoV-2 infections in hospital health personnel involved in the care of people with COVID-19 in HUGTiP and in Badalona Serveis Assistencials de Badalona. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection
- How many people
- 1,000 participants
- Where
- 2 sitesSpain
- Study dates
- 26 May 2020to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Adults (age> 18 years) who have worked during the epidemic period (March and April 2020) in the Infectious Diseases, Pneumology, Emergencies, ICU and Internal Medicine departments of HUGTiP, or in the Internal Medicine or Emergency departments of the Badalona Municipal Hospital.
Who may be able to join
- Adults (age> 18 years) who have worked during the epidemic period (March and April 2020) in the Infectious Diseases, Pneumology, Emergencies, ICU and Internal Medicine departments of HUGTiP, or in the Internal Medicine or Emergency departments of the Badalona Municipal Hospital.
Who cannot join
- Participation will be voluntary and no exclusion criteria are established
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916
Hospital Municipal de Badalona
Badalona, Barcelona, 08916
About this study
The objective of the study is to determine the percentage of past SARS-CoV-2 infections in hospital health personnel involved in the care of people with COVID-19 in HUGTiP and in Badalona Serveis Assistencials de Badalona.
Read the detailed description
Health personnel, especially hospital workers, have been a group especially affected by the COVID-19 epidemic. According to data from the Ministry of Health, in Spain 26% of health personnel have been infected by COVID-19, for a total of 31,053 professionals, representing up to 18.5% of all infections in the Spanish state, with variations between the different autonomous communities.1 In Italy it was estimated that up to 20% of health workers who responded to the epidemic would have been infected within a month.
There are no unified guidelines at the state level to determine infection prevention strategies in health personnel in order to validate them, beyond the use of Personal Protective Equipment (PPE) in personnel and general strategies for isolation and prevention of transmission.
There are no approved drug prevention strategies for primary prophylaxis against COVID-19.
Currently, there are no universal mass screening strategies (virological or immunological) to estimate the actual number of health personnel with an asymptomatic infection, as well as to determine the percentage of personnel who have already passed the infection asymptomatically or to determine the percentage of personnel A healthcare provider who has developed some form of immunity following a confirmed COVID-19 infection.
The HUGTiP, like the rest of Catalan hospitals, has suffered a massive avalanche accumulated in the time of admission by COVID-19, which has forced it to adopt different innovative strategies to visit them in emergencies, enter them in conventional hospitalization in a conventional plant, or attend them in the intensive care units that had to be created de novo against the clock. As of April 20, 2020, 1,000 hospital discharges have been granted to patients admitted by COVID-19 in conventional hospitalization plants and 170 more discharges from those admitted to intensive care units at HUGTiP. Likewise, the Municipal Hospital of Badalona has given a total of 300 discharges of patients with COVID-19, and they have also reported about 180 infections in their health personnel in this period.
Due to the high transmission rate of SARS-CoV-2 and its potential severity, several healthcare workers at HUGTiP decided on their own to take empirical primary prophylaxis with oral hydroxychloroquine individually as prevention of SARS-CoV-2 infection.
- Conditions
- SARS-CoV-2 Infection
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with past SARS-CoV-2 infection
Number of participants with past SARS-CoV-2 infection
Measured: Day 0
Secondary outcomes (5)
Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection
Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection
Measured: Day 0
Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.
Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.
Measured: Day 0
Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category.
Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category.
Measured: Day 0
Number of participants infected with SARS-CoV-2 that presented symptoms and their grade. Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment.
Number of participants infected with SARS-CoV-2 that presented symptoms and their grade.
Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment.
Measured: Day 0
Number of family members infected from each participant with SARS-CoV-2 infection
Number of family members infected from each participant with SARS-CoV-2 infection
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start26 May 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 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
- Case crossover
- Time perspective
- Other
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466462
- Sponsor's protocol ID
- COVID-Hosp
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study of COVID-19 Infection in Hospital Health Personnel
- ClinicalTrials.gov ID
- NCT04466462
- Acronym / sponsor ID
- COVID-Hosp
- Conditions
- SARS-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 10 Jul 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.
The objective of the study is to determine the percentage of past SARS-CoV-2 infections in hospital health personnel involved in the care of people with COVID-19 in HUGTiP and in Badalona Serveis Assistencials de Badalona.
Detailed description
Health personnel, especially hospital workers, have been a group especially affected by the COVID-19 epidemic. According to data from the Ministry of Health, in Spain 26% of health personnel have been infected by COVID-19, for a total of 31,053 professionals, representing up to 18.5% of all infections in the Spanish state, with variations between the different autonomous communities.1 In Italy it was estimated that up to 20% of health workers who responded to the epidemic would have been infected within a month.
There are no unified guidelines at the state level to determine infection prevention strategies in health personnel in order to validate them, beyond the use of Personal Protective Equipment (PPE) in personnel and general strategies for isolation and prevention of transmission.
There are no approved drug prevention strategies for primary prophylaxis against COVID-19.
Currently, there are no universal mass screening strategies (virological or immunological) to estimate the actual number of health personnel with an asymptomatic infection, as well as to determine the percentage of personnel who have already passed the infection asymptomatically or to determine the percentage of personnel A healthcare provider who has developed some form of immunity following a confirmed COVID-19 infection.
The HUGTiP, like the rest of Catalan hospitals, has suffered a massive avalanche accumulated in the time of admission by COVID-19, which has forced it to adopt different innovative strategies to visit them in emergencies, enter them in conventional hospitalization in a conventional plant, or attend them in the intensive care units that had to be created de novo against the clock. As of April 20, 2020, 1,000 hospital discharges have been granted to patients admitted by COVID-19 in conventional hospitalization plants and 170 more discharges from those admitted to intensive care units at HUGTiP. Likewise, the Municipal Hospital of Badalona has given a total of 300 discharges of patients with COVID-19, and they have also reported about 180 infections in their health personnel in this period.
Due to the high transmission rate of SARS-CoV-2 and its potential severity, several healthcare workers at HUGTiP decided on their own to take empirical primary prophylaxis with oral hydroxychloroquine individually as prevention of SARS-CoV-2 infection.
Study design
- Observational model
- Case crossover
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adults (age> 18 years) who have worked during the epidemic period (March and April 2020) in the Infectious Diseases, Pneumology, Emergencies, ICU and Internal Medicine departments of HUGTiP, or in the Internal Medicine or Emergency departments of the Badalona Municipal Hospital.
Key inclusion criteria (1 listed)
- Adults (age> 18 years) who have worked during the epidemic period (March and April 2020) in the Infectious Diseases, Pneumology, Emergencies, ICU and Internal Medicine departments of HUGTiP, or in the Internal Medicine or Emergency departments of the Badalona Municipal Hospital.
Key exclusion criteria (1 listed)
- Participation will be voluntary and no exclusion criteria are established
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
Number of participants with past SARS-CoV-2 infection
Time frame: Day 0
Number of participants with past SARS-CoV-2 infection
5 secondary outcomes
Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection
Time frame: Day 0
Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.
Time frame: Day 0
Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category.
Time frame: Day 0
Number of participants infected with SARS-CoV-2 that presented symptoms and their grade. Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment.
Time frame: Day 0
Number of family members infected from each participant with SARS-CoV-2 infection
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 2 sites 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 1 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: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with past SARS-CoV-2 infection (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2020.