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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504057
• Other study ID #: 02-22-161-060
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: June 13, 2025

Study information

• Verified date: April 2024
• Source: Consorci Sanitari de Terrassa
• Contact: Anna Puigdellivol, Ph.D
• Phone: 34-93-5884555
• Email: apuigdellivol[@]cst.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170000
• Est. completion date: June 13, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Exclusion Criteria: None

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Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Antihistamine
Observation of the rate of COVID19 infection, the rate of hospitalization and the rate of survival among patients previously treated with
• Amantadine
Observation of the rate of COVID19 infection, the rate of hospitalization and the rate of survival among patients previously treated with amantadine

Locations

Country	Name	City	State
Spain	Hospital de Terrassa	Terrassa	Barcelona
Spain	Hospital of Terrassa	Terrassa	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa	Institut Català de la Salut

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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 Phar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Admissions.	Rate of Hospitalization among COVID 19 infections	from march 2020.
Secondary	Survival	Survival among COVID1 hospitalized cases.	from march 2020
Secondary	Symptomatic infection	Patients suffering a symptomatic COVID19 infection within a determinate age group	from march 2020