Clinical trial NCT04367883: Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection
Official title: Evaluation of Influenza Vaccination and Treatment With ACEI and ARB in the Evolution of SARS-CoV2 Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID19
Influenza Vaccination
ACE Inhibitors
ARB
Antihistamine Allergy
Amantadine
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
Collaborators: name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
name: Institut Català de la Salut
First posted: 2020-04-29
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Primary outcomes:
measure: hospital output
timeFrame: from March 1, 2020.
Secondary outcomes:
measure: hospital stay
timeFrame: From March 1, 2020.
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Anna Puigdellívol-Sánchez, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Puigdellivol-Sanchez A, Juanes-Gonzalez M, Calderon-Valdiviezo A, Losa-Puig H, Valls-Foix R, Gonzalez-Salvador M, Lozano-Paz C, Vidal-Alaball J. COVID-19 in Relation to Chronic Antihistamine Prescription. Microorganisms. 2024 Dec 13;12(12):2589. doi: 10.3390/microorganisms12122589.