Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection

COVID19 Clinical Trial

Official title:

Evaluation of Influenza Vaccination and Treatment With ACEI and ARB in the Evolution of SARS-CoV2 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367883
• Other study ID #: 02-20-161-021
• Secondary ID: 02-22-161-060
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: December 31, 2024

Study information

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

Clinical Trial Summary

Some authors have proposed the use of the flu vaccine to reduce the severity of COVID-19 cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptor blockers (ARB), since this virus shares hemagglutinin as a transmission mechanism and acts on the ACE2 enzyme during infection.

Other authors described how none of the elderly patients receiving antihistamines and azythromycin in two nursing homes in Toledo -Spain- during the first wave died or needed hospital admission, even considering that 100% of residents had a positive serological test after that wave. Other authors have described a positive evolution in patients receiving amantadine for their Parkinson's disease.

The aim is to evaluate whether the admitted patients who are previously vaccinated or those who were already receiving these treatments showed a better evolution.

Description:

The number COVID cases would be related to hospital admissions. Among hospital admissions, the number of previous treatments, the length of admission, the need or not of the Intensive Care Unit (ICU) and their final status (survivors or non survivors) would be studied.

If patients that previously received the influenza vaccine or treated with ACEI, ARB, antihistamines or amantadine showed a better evolution, it would be proposed to extend vaccination and the inclusion of ACE inhibitors, ARB, antihistamines or amantadine in the treatment of infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hospital Admissions at the Hospital of Terrassa from March 1, 2020 for any cause.

Exclusion Criteria:

• None.

• For comparison of percentage of Influenza vaccination, ACEI and ARB vs general population, patients from outside the reference area of the Terrassa Health Consortium would be excluded.

Related Conditions & MeSH terms

• ACE Inhibitors
• Amantadine
• ARB
• COVID-19
• COVID19
• Influenza Vaccination
• Influenza, Human

Intervention

Drug:
• Antihistamine
No intervention is performed. We propose an observational study.
• Amantadine
No intervention is performed. We propose an observational study
• ACEI
No intervention is performed. We propose an observational study.
• ARB
No intervention is performed. We propose an observational study.

Other:
• Influenza vaccine and COVID
No intervention is performed. We propose an observational study.

Locations

Country	Name	City	State
Spain	Hospital de Terrassa	Terrassa	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa	Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut Català de la Salut

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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

Gurwitz D. Angiotensin receptor blockers as tentative SARS-CoV-2 therapeutics. Drug Dev Res. 2020 Aug;81(5):537-540. doi: 10.1002/ddr.21656. Epub 2020 Mar 4. — 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 Pharmacol Ther. 2021 Apr;67:101989. doi: 10.1016/j.pupt.2021.101989. Epub 2021 Jan 16. — View Citation

Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital output	exitus vs hospital output	from March 1, 2020.
Secondary	hospital stay	length of the hospital stay	From March 1, 2020.