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

Recruiting

• Conditions: COVID-19
• Interventions: Drug: Antihistamine; Drug: Amantadine

• Registration Number: NCT05504057
• Lead Sponsor: Consorci Sanitari de Terrassa

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Primary Completion: 2025-01-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-25
• Study Completion: 2028-02-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140660

Inclusion Criteria

Patients having chronic treatment with antihistamines or amantadine -

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic treatment with antihistamines or amantadine	Antihistamine	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.
Patients with chronic treatment with antihistamines or amantadine	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.

Primary Outcome Measures

Name	Time	Method
Hospital Admissions.	from march 2020.	Rate of Hospitalization among COVID 19 infections

Secondary Outcome Measures

Name	Time	Method
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
Postcovid syndrome	from april 2020	Patients developing postcovid syndrome after COVID19 infection
Thrombosis	from april 2020	Patients developing thrombosis (with particular assessment of stroke, cardiac infarction, retinal vessels and pulmonary embolism)

Trial Locations

Locations (2)

Hospital de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital of Terrassa; 🇪🇸 Terrassa, Barcelona, Spain