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

NCT05504057 | Recruiting FDA Drug

• 1 other identifier: 02-22-161-060
• Study Type: observational
• Target: 140,660
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

antihistamines; amantadine; hospital admissions; survival

Outcome Measures

Primary Outcomes (1)

• Hospital Admissions.

  Rate of Hospitalization among COVID 19 infections

  from march 2020.

Secondary Outcomes (4)

• Survival

  from march 2020

• Symptomatic infection

  from march 2020

• Postcovid syndrome

  from april 2020

• Thrombosis

  from april 2020

Study Arms (2)

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.

Drug: Antihistamine; Drug: Amantadine

Other population of the THC

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

Interventions

Antihistamine 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

Also known as: Antihistamine as crhonic treatment and COVID19 infection.

Patients with chronic treatment with antihistamines or amantadine

Amantadine 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

Also known as: Amantadine as chronic treatment and COVID19 infection.

Patients with chronic treatment with antihistamines or amantadine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population assigned to the Public and free Access Terrassa Health Consortium

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead
• Institut Català de la Salut: collaborator

Study Sites (2)

Hospital de Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

Hospital of Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

Related Publications (5)

• 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, 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 RESULT

• 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, 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 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Histamine Antagonists; Amantadine

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

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

Study Officials

• Anna Puigdellívol, PhD

  Terrassa Health Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Puigdellivol, Ph.D

CONTACT

34-93-5884555; apuigdellivol@cst.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• 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 (2)