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Cross-sectional Study of COVID-19 Infection in Hospital Health Personnel

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ClinicalTrials.gov Identifier: NCT04466462
Recruitment Status : Completed
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Fundacio Lluita Contra la SIDA

Brief 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.

Condition or disease
SARS-CoV-2 Infection

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.

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Case-Crossover
Time Perspective: Other
Official Title: Cross-sectional Study of COVID-19 Infection in Hospital Health Personnel
Actual Study Start Date : May 26, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of participants with past SARS-CoV-2 infection [ Time Frame: Day 0 ]
    Number of participants with past SARS-CoV-2 infection


Secondary Outcome Measures :
  1. 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 who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection

  2. Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19. [ Time Frame: Day 0 ]
    Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.

  3. 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 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.

  4. 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 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.


  5. Number of family members infected from each participant with SARS-CoV-2 infection [ Time Frame: Day 0 ]
    Number of family members infected from each participant with SARS-CoV-2 infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participation will be voluntary and no exclusion criteria are established

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): NCT04466462


Locations
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Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Hospital Municipal de Badalona
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Fundacio Lluita Contra la SIDA
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Responsible Party: Fundacio Lluita Contra la SIDA
ClinicalTrials.gov Identifier: NCT04466462    
Other Study ID Numbers: COVID-Hosp
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 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