Antihistamines, Amantadine and Evolution of the SARS-CoV-2 Infection

NCT ID: NCT05504057

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

140660 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2028-02-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with chronic treatment with antihistamines or amantadine

The % of patients having antihistamines or amantadine as chronic treatment that suffered COVID would be compared to the population of the Terrassa Health Consortium (THC) of the same age groups.

Antihistamine

Intervention Type DRUG

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

Amantadine

Intervention Type DRUG

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

Other population of the THC

The % of patients of the Terrassa Health Consortium that suffered COVID19 infection of the same age groups.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Antihistamine as crhonic treatment and COVID19 infection. Amantadine as chronic treatment and COVID19 infection.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut Català de la Salut

OTHER

Sponsor Role collaborator

Consorci Sanitari de Terrassa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anna Puigdellívol-Sánchez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna Puigdellívol, PhD

Role: PRINCIPAL_INVESTIGATOR

Terrassa Health Consortium

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Terrassa

Terrassa, Barcelona, Spain

Site Status RECRUITING

Hospital of Terrassa

Terrassa, Barcelona, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anna Puigdellivol, Ph.D

Role: CONTACT

34-93-5884555

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anna Puigdellívol-Sánchez, Ph.D.

Role: primary

34-93-5884555

Anna Puigdellívol, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33465426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33604795 (View on PubMed)

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.

Reference Type RESULT
PMID: 39770791 (View on PubMed)

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.

Reference Type RESULT
PMID: 39459868 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

02-22-161-060

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of HS-10517 in Chinese Adult Participants
NCT05779579 UNKNOWN PHASE1/PHASE2