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

NCT04367883 | Recruiting FDA Drug

• 2 other identifiers: 02-20-161-02102-22-161-060
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19; Influenza Vaccination; ACE Inhibitors; ARB; Antihistamine Allergy; Amantadine

Outcome Measures

Primary Outcomes (1)

• hospital output

  exitus vs hospital output

  from March 1, 2020.

Secondary Outcomes (1)

• hospital stay

  From March 1, 2020.

Study Arms (3)

Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population

Observation of patient characteristics of hospital incomes in Hospital of Terrassa from March 1, 2020. No intervention is performed.

Drug: Antihistamine; Drug: Amantadine; Drug: ACEI; Drug: ARB; Other: Influenza vaccine and COVID

Evolution of COVID cases in patients receiving antihistamines

COVID cases, hospital admissions, postcovid syndrome, thrombosis and deaths related to COVID from march 1, 2020 in patients of the participating institutions receiving chronic treatment with antihistamines. No intervention is performed.

Drug: Antihistamine

Evolution of COVID cases in patients receiving amantadine.

COVID cases, hospital admissions, postcovid syndrome, thrombosis and deaths related to COVID from march 1, 2020 in patients of the participating institutions receiving chronic treatment with amantadine. No intervention is performed.

Drug: Amantadine

Interventions

Antihistamine DRUG

No intervention is performed. We propose an observational study.

Also known as: Antihistamines for COVID

Evolution of COVID cases in patients receiving antihistamines; Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population

Amantadine DRUG

No intervention is performed. We propose an observational study

Also known as: Amantadine for COVID

Evolution of COVID cases in patients receiving amantadine.; Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population

ACEI DRUG

No intervention is performed. We propose an observational study.

Also known as: ACEI and COVID

Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population

ARB DRUG

No intervention is performed. We propose an observational study.

Also known as: ARB and COVID

Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population

Influenza vaccine and COVID OTHER

No intervention is performed. We propose an observational study.

Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead
• Institut Català de la Salut: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator

Study Sites (1)

Hospital de Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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: 10.3390/healthcare13111270.

  PMID: 40508884 RESULT

MeSH Terms

Conditions

COVID-19; Influenza, Human

Interventions

Histamine Antagonists; Amantadine; Angiotensin-Converting Enzyme Inhibitors; Influenza Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Protease Inhibitors; Enzyme Inhibitors; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Anna Puigdellívol-Sánchez, Ph D

  Consorci Sanitari de Terrassa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Puigdellívol-Sánchez, Ph.D.

CONTACT

34-93-5884555; apuigdellivol@cst.cat

Mar Muñoz

CONTACT

34-93-7003657; Reserca@cst.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 29, 2020
• Study Start: March 1, 2020
• Primary Completion: January 19, 2025
• Study Completion (Estimated): February 24, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

ES (1)