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Influenza Vaccination, ACEI and ARB in the Evolution of SARS-Covid19 Infection

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: NCT04367883
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : August 21, 2020
Sponsor:
Collaborators:
Jordi Gol i Gurina Foundation
Institut Català de la Salut
Information provided by (Responsible Party):
Anna Puigdellívol-Sánchez, Consorci Sanitari de Terrassa

Brief Summary:

Some authors have proposed the use of the flu vaccine to reduce the severity of COVID-19 cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptor blockers (ARB), since this virus shares hemagglutinin as a transmission mechanism and acts on the ACE2 enzyme during infection.

The aim is to evaluate whether the admitted patients who are previously vaccinated or those who were already receiving treatment show a better evolution.


Condition or disease Intervention/treatment
COVID19 Influenza Vaccination ACE Inhibitors ARB Drug: ACE inhibitor Drug: ARB

Detailed Description:

The number of patients admitted at the hospital, their comorbidity (Charlson index), the number of previous treatments, the length of admission, the need or not of the Intensive Care Unit (ICU) and their final status (survivors or non survivors) would be studied.

If patients that previously received the influenza vaccine or treated with ACEI or ARB showed a better evolution, it would be proposed to extend vaccination and the inclusion of ACE inhibidors and ARB in the treatment of infection.

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Study Type : Observational
Estimated Enrollment : 2574 participants
Observational Model: Other
Time Perspective: Other
Official Title: Evaluation of Influenza Vaccination and Treatment With ACEI and ARB in the Evolution of SARS-Covid19 Infection
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CST Hospital Incomes

Observation of patient characteristics of hospital incomes in Hospital of Terrassa from March 1, 2020.

No intervention is performed.

Drug: ACE inhibitor
If evolution is favorable in patients treated with ACE as assessed at the first step of the study, this treatment would be added in a random selection of new admitted patients suffering Covid19, and results would be compared to a control group of admitted patients.
Other Name: ACE inhibitors to treat COVID19 infection

Drug: ARB
If evolution is favorable in patients treated with ARB as assessed at the first step of the study, this treatment would be added in a random selection of new admitted patients suffering Covid19, and results would be compared to a control group of admitted patients.
Other Name: ARB to treat COVID10 infection.




Primary Outcome Measures :
  1. hospital output [ Time Frame: from March 1, 2020. ]
    exitus vs hospital output


Secondary Outcome Measures :
  1. hospital stay [ Time Frame: From March 1, 2020. ]
    lenght of the hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All hospital admissions in the Hospital of Terrassa from March 1, 2020 were innitially included.

Population of reference: the population assigned to the Terrassa Health Consortium population.

Criteria

Inclusion Criteria:

  • Hospital Admissions at the Hospital of Terrassa from March 1, 2020 for any cause.

Exclusion Criteria:

  • None.
  • For comparison of percentage of Influenza vaccination, ACEI and ARB vs general population, patients from outsite the reference area of the Terrassa Health Consortium would be excluded.

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): NCT04367883


Contacts
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Contact: Anna Puigdellívol-Sánchez, Ph.D. 34-93-5884555 apuigdellivol@cst.cat
Contact: Mar Muñoz 34-93-7003657 ext 1895 Reserca@cst.cat

Locations
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Spain
Hospital de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08227
Contact: Anna Puigdellívol-Sánchez, Ph.D.    34-93-5884555    apuigdellivol@cst.cat   
Sponsors and Collaborators
Consorci Sanitari de Terrassa
Jordi Gol i Gurina Foundation
Institut Català de la Salut
Investigators
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Principal Investigator: Anna Puigdellívol-Sánchez, Ph D Consorci Sanitari de Terrassa
Publications of Results:
Other Publications:
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Responsible Party: Anna Puigdellívol-Sánchez, M.D., Ph.D., Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier: NCT04367883    
Other Study ID Numbers: 02-20-161-021
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action