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

Sponsor

Consorci Sanitari de Terrassa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05504057

Collaborator

Institut Català de la Salut (Other)

170,000

Enrollment

Locations

63.4

Anticipated Duration (Months)

85000

Patients Per Site

1340.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Antihistamine Drug: Amantadine

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 and survival 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 Design

Study Type:

Observational

Anticipated Enrollment :

170000 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Evaluation of Treatments With Antihistamines and Amantadine in the Evolution of the SARS-CoV-2 Infection

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Jun 13, 2025

Arms and Interventions

Arm	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.	Drug: Antihistamine Observation of the rate of COVID19 infection, the rate of hospitalization and the rate of survival among patients previously treated with Other Names: Antihistamine as crhonic treatment and COVID19 infection. Drug: Amantadine Observation of the rate of COVID19 infection, the rate of hospitalization and the rate of survival among patients previously treated with amantadine Other Names: Amantadine as chronic treatment and COVID19 infection.
Other population of the THC The % of patients of the Terrassa Health Consortium that suffered COVID19 infection of the same age groups.

Arm

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.

Drug: Antihistamine

Observation of the rate of COVID19 infection, the rate of hospitalization and the rate of survival among patients previously treated with

Other Names:

Antihistamine as crhonic treatment and COVID19 infection.

Drug: Amantadine

Observation of the rate of COVID19 infection, the rate of hospitalization and the rate of survival among patients previously treated with amantadine

Other Names:

Amantadine as chronic treatment and COVID19 infection.

Other population of the THC

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

Outcome Measures

Primary Outcome Measures

Hospital Admissions. [from march 2020.]
Rate of Hospitalization among COVID 19 infections

Secondary Outcome Measures

Survival [from march 2020]
Survival among COVID1 hospitalized cases.
Symptomatic infection [from march 2020]
Patients suffering a symptomatic COVID19 infection within a determinate age group

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Exclusion Criteria: None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Terrassa	Terrassa	Barcelona	Spain	08227
2	Hospital of Terrassa	Terrassa	Barcelona	Spain	08227

Sponsors and Collaborators

Consorci Sanitari de Terrassa
Institut Català de la Salut

Investigators

Principal Investigator: Anna Puigdellívol, PhD, Terrassa Health Consortium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Puigdellívol-Sánchez, Principal Investigator, Consorci Sanitari de Terrassa

ClinicalTrials.gov Identifier:

NCT05504057

Other Study ID Numbers:

02-22-161-060

First Posted:

Aug 17, 2022

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Anna Puigdellívol-Sánchez, Principal Investigator, Consorci Sanitari de Terrassa

Additional relevant MeSH terms:

COVID-19

Amantadine

Histamine Antagonists

Histamine H1 Antagonists

Study Results

No Results Posted as of Aug 23, 2022