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Recruiting NCT04367883

Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection

Observational COVID19 Influenza Vaccination ACE Inhibitors ARB

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Antihistamine, Amantadine, ACEI, ARB.
Who it may be relevant to
Registry conditions: COVID19, Influenza Vaccination, ACE Inhibitors, ARB. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Influenza Vaccination and Treatment With ACEI and ARB in the Evolution of SARS-CoV2 Infection

Overview

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. Other authors described how none of the elderly patients receiving antihistamines and azythromycin in two nursing homes in Toledo -Spain- during the first wave died or needed hospital admission, even considering that 100% of residents had a positive serological test after that wave. Other authors have described a positive evolution in patients receiving amantadine for their Parkinson's disease. The aim is to evaluate whether the admitted patients who are previously vaccinated or those who were already receiving these treatments showed a better evolution.

Detailed description

The number COVID cases would be related to hospital admissions. Among hospital admissions, 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, ARB, antihistamines or amantadine showed a better evolution, it would be proposed to extend vaccination and the inclusion of ACE inhibitors, ARB, antihistamines or amantadine in the treatment of infection.

Interventions

  • Drug Antihistamine
    No intervention is performed. We propose an observational study.
  • Drug Amantadine
    No intervention is performed. We propose an observational study
  • Drug ACEI
    No intervention is performed. We propose an observational study.
  • Drug ARB
    No intervention is performed. We propose an observational study.
  • Other Influenza vaccine and COVID
    No intervention is performed. We propose an observational study.

Primary outcome measures

  • hospital output [Time frame: from March 1, 2020.]
Secondary outcome measures (1)
  • hospital stay [Time frame: From March 1, 2020.]

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 outside the reference area of the Terrassa Health Consortium would be excluded.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital de Terrassa — Terrassa

Publications

  • Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3. PMID 32052466
  • Gurwitz D. Angiotensin receptor blockers as tentative SARS-CoV-2 therapeutics. Drug Dev Res. 2020 Aug;81(5):537-540. doi: 10.1002/ddr.21656. Epub 2020 Mar 4. PMID 32129518
  • Moran Blanco JI, Alvarenga Bonilla JA, Homma S, Suzuki K, Fremont-Smith P, Villar Gomez de Las Heras K. Antihistamines and azithromycin as a treatment for COVID-19 on primary health care - A retrospective observational study in elderly patients. Pulm Pharmacol Ther. 2021 Apr;67:101989. doi: 10.1016/j.pupt.2021.101989. Epub 2021 Jan 16. PMID 33465426
  • Cortes-Borra A, Aranda-Abreu GE. Amantadine in the prevention of clinical symptoms caused by SARS-CoV-2. Pharmacol Rep. 2021 Jun;73(3):962-965. doi: 10.1007/s43440-021-00231-5. Epub 2021 Feb 18. PMID 33604795
  • Puigdellivol-Sanchez A, Juanes-Gonzalez M, Calderon-Valdiviezo A, Valls-Foix R, Gonzalez-Salvador M, Lozano-Paz C, Vidal-Alaball J. COVID-19 in Relation to Polypharmacy and Immunization (2020-2024). Viruses. 2024 Sep 27;16(10):1533. doi: 10.3390/v16101533. PMID 39459868
  • Puigdellivol-Sanchez A, Juanes-Gonzalez M, Calderon-Valdiviezo AI, Losa-Puig H, Gonzalez-Salvador M, Leon-Perez M, Pueyo-Anton L, Franco-Romero M, Lozano-Paz C, Cortes-Borra A, Valls-Foix R. COVID-19 Pandemic Waves and 2024-2025 Winter Season in Relation to Angiotensin-Converting Enzyme Inhibitors, Angiotensin Receptor Blockers and Amantadine. Healthcare (Basel). 2025 May 27;13(11):1270. doi: 10.3 PMID 40508884

Identifiers

NCT: NCT04367883 · 02-20-161-021 · 02-22-161-060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗