Clinical trial NCT05504057: Antihistamines, Amantadine and Evolution of the SARS-CoV-2 Infection
Official title: Evaluation of Treatments With Antihistamines and Amantadine in the Evolution of the SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: antihistamines
amantadine
hospital admissions
survival
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
First posted: 2022-08-17
Enrollment: 140660
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population assigned to the Public and free Access Terrassa Health Consortium

Brief summary: 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.

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

Exclusion Criteria: None

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Primary outcomes:
measure: Hospital Admissions.
timeFrame: from march 2020.
Secondary outcomes:
measure: Survival
timeFrame: from march 2020
measure: Symptomatic infection
timeFrame: from march 2020
measure: Postcovid syndrome
timeFrame: from april 2020
measure: Thrombosis
timeFrame: from april 2020
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital de Terrassa
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital of Terrassa
state: Barcelona
Study officials:
affiliation: Terrassa Health Consortium
name: Anna Puigdellívol, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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, 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.
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.