- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05504057
Antihistamines, Amantadine and Evolution of COVID-19
Evaluation of Treatments With Antihistamines and Amantadine in the Evolution of the SARS-CoV-2 Infection
Study Overview
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anna Puigdellivol, Ph.D
- Phone Number: 34-93-5884555
- Email: apuigdellivol@cst.cat
Study Locations
-
-
Barcelona
-
Terrassa, Barcelona, Spain, 08227
- Recruiting
- Hospital de Terrassa
-
Contact:
- Anna Puigdellívol-Sánchez, Ph.D.
- Phone Number: 34-93-5884555
- Email: apuigdellivol@cst.cat
-
Terrassa, Barcelona, Spain, 08227
- Recruiting
- Hospital of Terrassa
-
Contact:
- Anna Puigdellívol, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Patients having chronic treatment with antihistamines or amantadine -
Exclusion Criteria: None
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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
Other Names:
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 Names:
|
|
Other population of the THC
The % of patients of the Terrassa Health Consortium that suffered COVID19 infection of the same age groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Admissions.
Time Frame: from march 2020.
|
Rate of Hospitalization among COVID 19 infections
|
from march 2020.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival
Time Frame: from march 2020
|
Survival among COVID1 hospitalized cases.
|
from march 2020
|
|
Symptomatic infection
Time Frame: from march 2020
|
Patients suffering a symptomatic COVID19 infection within a determinate age group
|
from march 2020
|
|
Postcovid syndrome
Time Frame: from april 2020
|
Patients developing postcovid syndrome after COVID19 infection
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from april 2020
|
|
Thrombosis
Time Frame: from april 2020
|
Patients developing thrombosis (with particular assessment of stroke, cardiac infarction, retinal vessels and pulmonary embolism)
|
from april 2020
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna Puigdellívol, PhD, Terrassa Health Consortium
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Histamine Agents
- Neurotransmitter Agents
- Organic Chemicals
- Pharmacologic Actions
- Chemical Actions and Uses
- Hydrocarbons
- Hydrocarbons, Cyclic
- Adamantane
- Bridged-Ring Compounds
- Amantadine
- Histamine Antagonists
Other Study ID Numbers
- 02-22-161-060 (Idem + antihistamines, amantadine in the evolution of COVID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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