Menu
Recruiting NCT05504057

Antihistamines, Amantadine and Evolution of COVID-19

Observational COVID-19

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.
Who it may be relevant to
Registry conditions: COVID-19. 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 Treatments With Antihistamines and Amantadine in the Evolution of the SARS-CoV-2 Infection

Overview

The rates of symptomatic COVID19 infection, hospital admission among COVID19 cases and survival would be quantified in patiens chronically treated with antihistamines or amantadine, with the aim of determining the role of antihistamines and amantadine in the evolution of COVID19.

Detailed description

BACKGROUND: According to previous reports, all 84 eldery residents in nuersing homes in Yespes (Toledo, Spain), had a 100% of positive serology for COVID-19 in June 2020, but none died nor hospitalized after receiving early treatment with antihistamines. Other case reports have suggested a protective role of amantadine, since infected patients showed a very mild COVID19 infection.

OBJECTIVES.Determine the role of antihistamines and amantadine in the evolution of COVID19.

METHODS. Describe the rate of hospitalization, ICU, survival, postcovid syndrome and thrombosis among COVID 19 cases having antihistamines and amantadine as chronic treatments.

The rates would be stratified by age groups and compared with the same age groups of the population assigned to the public free Access Terrassa Health Consortium.

Interventions

  • Drug Antihistamine
    Observation of the rate of COVID19 infection, the rate of hospitalization, the rate of survival and postcovid syndrome and thrombosis among patients previously treated with antihistamines
  • Drug Amantadine
    Observation of the rate of COVID19 infection, the rate of hospitalization, the rate of survival and the rate of postcovid syndrome and thrombosis among patients previously treated with amantadine

Primary outcome measures

  • Hospital Admissions. [Time frame: from march 2020.]
Secondary outcome measures (4)
  • Survival [Time frame: from march 2020]
  • Symptomatic infection [Time frame: from march 2020]
  • Postcovid syndrome [Time frame: from april 2020]
  • Thrombosis [Time frame: from april 2020]

Eligibility criteria

Inclusion Criteria: Patients having chronic treatment with antihistamines or amantadine -

Exclusion Criteria: None

\-

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

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Spain · 2 centers
  • Hospital de Terrassa — Terrassa
  • Hospital of Terrassa — Terrassa

Publications

  • 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, 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. PMID 39770791
  • 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, Arevalo-Genicio A, Garcia-Arque MC, Gragea-Nocete M, Lozano-Paz C, Moro-Casasola V, Perez-Diaz C, Valls-Foix R, Roca-Puig R, Llistosella M. Long COVID and Reduced Thrombosis in Antihistamine-Treated Patients: An Observational Study in the Metropolitan Area of Barcelona. Viruses. 2026 Feb 2;18(2):197. doi: 10.3390/v18020197. PMID 41754542

Identifiers

NCT: NCT05504057 · 02-22-161-060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗