Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : March 10, 2022
Sponsor:
Collaborators:
Jordi Gol i Gurina Foundation
Institut Català de la Salut
Information provided by (Responsible Party):
Anna Puigdellívol-Sánchez, Consorci Sanitari de Terrassa

Tracking Information
First Submitted Date April 28, 2020
First Posted Date April 29, 2020
Last Update Posted Date March 10, 2022
Actual Study Start Date March 1, 2020
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 11, 2020)
hospital output [ Time Frame: from March 1, 2020. ]
exitus vs hospital output
Original Primary Outcome Measures
 (submitted: April 28, 2020)
hospital output [ Time Frame: from March 1, 2020. ]
exitus vs hospital output and lenght of the hospital stay.
Change History
Current Secondary Outcome Measures
 (submitted: August 11, 2020)
hospital stay [ Time Frame: From March 1, 2020. ]
lenght of the hospital stay
Original Secondary Outcome Measures
 (submitted: April 28, 2020)
length of ICU admission [ Time Frame: From March 1, 2020. ]
number of days at ICU.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Influenza Vaccination, ACEI and ARB in the Evolution of SARS-Covid19 Infection
Official Title Evaluation of Influenza Vaccination and Treatment With ACEI and ARB in the Evolution of SARS-Covid19 Infection
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.

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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • COVID19
  • Influenza Vaccination
  • ACE Inhibitors
  • ARB
Intervention
  • 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.
Study Groups/Cohorts CST Hospital Incomes

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

No intervention is performed.

Interventions:
  • Drug: ACE inhibitor
  • Drug: ARB
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 28, 2020)
2574
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2023
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Anna Puigdellívol-Sánchez, Ph.D. 34-93-5884555 apuigdellivol@cst.cat
Contact: Mar Muñoz 34-93-7003657 ext 1895 Reserca@cst.cat
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04367883
Other Study ID Numbers 02-20-161-021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Anna Puigdellívol-Sánchez, Consorci Sanitari de Terrassa
Study Sponsor Consorci Sanitari de Terrassa
Collaborators
  • Jordi Gol i Gurina Foundation
  • Institut Català de la Salut
Investigators
Principal Investigator: Anna Puigdellívol-Sánchez, Ph D Consorci Sanitari de Terrassa
PRS Account Consorci Sanitari de Terrassa
Verification Date March 2022