- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04367883
Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection
Evaluation of Influenza Vaccination and Treatment With ACEI and ARB in the Evolution of SARS-CoV2 Infection
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.
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anna Puigdellívol-Sánchez, Ph.D.
- Phone Number: 34-93-5884555
- Email: apuigdellivol@cst.cat
Study Contact Backup
- Name: Mar Muñoz
- Phone Number: 1895 34-93-7003657
- Email: Reserca@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
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
All hospital admissions in the Hospital of Terrassa from March 1, 2020 were innitially included.
Population of reference: the population assigned to the Terrassa Health Consortium population.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population
Observation of patient characteristics of hospital incomes in Hospital of Terrassa from March 1, 2020. No intervention is performed. |
No intervention is performed.
We propose an observational study.
Other Names:
No intervention is performed.
We propose an observational study
Other Names:
No intervention is performed.
We propose an observational study.
Other Names:
No intervention is performed.
We propose an observational study.
Other Names:
No intervention is performed.
We propose an observational study.
|
|
Evolution of COVID cases in patients receiving antihistamines
COVID cases, hospital admissions, postcovid syndrome, thrombosis and deaths related to COVID from march 1, 2020 in patients of the participating institutions receiving chronic treatment with antihistamines. No intervention is performed. |
No intervention is performed.
We propose an observational study.
Other Names:
|
|
Evolution of COVID cases in patients receiving amantadine.
COVID cases, hospital admissions, postcovid syndrome, thrombosis and deaths related to COVID from march 1, 2020 in patients of the participating institutions receiving chronic treatment with amantadine. No intervention is performed. |
No intervention is performed.
We propose an observational study
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hospital output
Time Frame: from March 1, 2020.
|
exitus vs hospital output
|
from March 1, 2020.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hospital stay
Time Frame: From March 1, 2020.
|
length of the hospital stay
|
From March 1, 2020.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna Puigdellívol-Sánchez, Ph D, Consorci Sanitari de Terrassa
Publications and helpful links
General Publications
- 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.
- 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.
- 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, 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, Juanes-Gonzalez M, Calderon-Valdiviezo AI, Losa-Puig H, Gonzalez-Salvador M, Leon-Perez M, Pueyo-Anton L, Franco-Romero M, Lozano-Paz C, Cortes-Borra A, Valls-Foix R. COVID-19 Pandemic Waves and 2024-2025 Winter Season in Relation to Angiotensin-Converting Enzyme Inhibitors, Angiotensin Receptor Blockers and Amantadine. Healthcare (Basel). 2025 May 27;13(11):1270. doi: 10.3390/healthcare13111270.
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
- Orthomyxoviridae Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Influenza, Human
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protease Inhibitors
- Enzyme Inhibitors
- Histamine Agents
- Neurotransmitter Agents
- Organic Chemicals
- Pharmacologic Actions
- Chemical Actions and Uses
- Hydrocarbons
- Hydrocarbons, Cyclic
- Biological Products
- Complex Mixtures
- Adamantane
- Bridged-Ring Compounds
- Vaccines
- Viral Vaccines
- Amantadine
- Angiotensin-Converting Enzyme Inhibitors
- Histamine Antagonists
- Influenza Vaccines
Other Study ID Numbers
- 02-20-161-021
- 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)?
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.
Clinical Trials on COVID19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitatsspital ZurichEnrolling by invitation
-
Alexandria UniversityCompleted
-
Erasmus Medical CenterUniversity Medical Center Groningen; Academisch Medisch Centrum - Universiteit... and other collaboratorsRecruiting
Clinical Trials on Antihistamine
-
Johanna Maria VermeulenMermaid Medicine®; Affiliated Hospital of Nanjing University of Chinese MedicineCompleted
-
Indonesia UniversityCompletedChronic Kidney Disease Requiring Chronic DialysisIndonesia
-
Paul Peng, MD PhD MSCRNot yet recruitingComputed Tomography | Hypersensitivity Reaction | Premedication | Allergic Reaction to Contrast Media
-
Gachon University Gil Medical CenterHallym University Medical Center; Hallym University Kangnam Sacred Heart Hospital and other collaboratorsRecruitingAllergic RhinitisKorea, Republic of
-
University of CincinnatiUnknownIrritable Bowel Syndrome | Dermatographism | Post-prandial Diarrhea
-
Consorci Sanitari de TerrassaInstitut Català de la SalutRecruiting
-
CinnagenCompletedMucopolysaccharidosis Type 1Iran, Islamic Republic of
-
SanofiRegeneron PharmaceuticalsCompletedCold UrticariaUnited States, Argentina, Canada, Germany, Japan
-
China Medical University HospitalCompleted
-
National Institute on Deafness and Other Communication...Completed