COVID19NCT04367883
Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection
An observational study of COVID19 and Influenza Vaccination, run by Consorci Sanitari de Terrassa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID19, Influenza Vaccination, ACE Inhibitors
- What is being tested?
- Antihistamine, Amantadine and ACEI
- Type of treatment
- Vaccines
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 24 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Hospital Admissions at the Hospital of Terrassa from March 1, 2020 for any cause.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Terrassa
Terrassa, Barcelona, 08227
Anna Puigdellívol-Sánchez, Ph.D., 34-93-5884555, apuigdellivol@cst.cat
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID19, Influenza Vaccination, ACE Inhibitors, ARB, Antihistamine Allergy, Amantadine
- Being tested
- Antihistamine, Amantadine, ACEI, ARB, Influenza vaccine and COVID
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntihistamineDrug
Also called Antihistamines for COVID
No intervention is performed. We propose an observational study.
AmantadineDrug
Also called Amantadine for COVID
No intervention is performed. We propose an observational study
ACEIDrug
Also called ACEI and COVID
No intervention is performed. We propose an observational study.
ARBDrug
Also called ARB and COVID
No intervention is performed. We propose an observational study.
Influenza vaccine and COVIDOther
No intervention is performed. We propose an observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Antihistamine; Drug: Amantadine; Drug: ACEI; Drug: ARB; Other: Influenza vaccine and COVID | |
| 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. Receives: Drug: Antihistamine | |
| 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. Receives: Drug: Amantadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital output
exitus vs hospital output
Measured: from March 1, 2020.
Secondary outcomes (1)
hospital stay
length of the hospital stay
Measured: From March 1, 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Mar 2020
- Primary completion19 Jan 2025
- Study completion24 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut Català de la Salut
- Responsible party
- Principal investigator, Anna Puigdellívol-Sánchez, Consorci Sanitari de Terrassa
- Investigators
- Anna Puigdellívol-Sánchez, Ph D, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367883
- Sponsor's protocol ID
- 02-20-161-021
- Other IDs
- 02-22-161-060
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2020
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32052466Gurwitz 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.
PubMed 32129518Moran 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.
PubMed 33465426Cortes-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.
PubMed 33604795Puigdellivol-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.
PubMed 39459868Puigdellivol-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.
PubMed 40508884
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Influenza Vaccination and Treatment With ACEI and ARB in the Evolution of SARS-CoV2 Infection
- ClinicalTrials.gov ID
- NCT04367883
- Acronym / sponsor ID
- 02-20-161-021
- Conditions
- COVID19, Influenza Vaccination, ACE Inhibitors, ARB, Antihistamine Allergy, Amantadine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut Català de la Salut
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 19 Jan 2025 (actual)
- Study completion
- 24 Feb 2028 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population | – | Drug: Antihistamine, Drug: Amantadine, Drug: ACEI, Drug: ARB, Other: Influenza vaccine and COVIDObservation of patient characteristics of hospital incomes in Hospital of Terrassa from March 1, 2020. No intervention is performed. |
| Evolution of COVID cases in patients receiving antihistamines | – | Drug: AntihistamineCOVID 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. |
| Evolution of COVID cases in patients receiving amantadine. | – | Drug: AmantadineCOVID 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Hospital Admissions at the Hospital of Terrassa from March 1, 2020 for any cause.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntihistamineAlso: Antihistamines for COVIDNo intervention is performed. We propose an observational study. | Drug | Evolution of COVID cases in patients receiving antihistamines, Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population |
| AmantadineAlso: Amantadine for COVIDNo intervention is performed. We propose an observational study | Drug | Evolution of COVID cases in patients receiving amantadine., Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population |
| ACEIAlso: ACEI and COVIDNo intervention is performed. We propose an observational study. | Drug | Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population |
| ARBAlso: ARB and COVIDNo intervention is performed. We propose an observational study. | Drug | Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population |
| Influenza vaccine and COVIDNo intervention is performed. We propose an observational study. | Other | Hospital admissions, postcovid syndrome and thrombosis among COVID cases in CST population |
Primary outcome
hospital output
Time frame: from March 1, 2020.
exitus vs hospital output
1 secondary outcome
hospital stay
Time frame: From March 1, 2020.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 32052466Zhang 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.
- Background: PubMed 32129518Gurwitz 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.
- Background: PubMed 33465426Moran 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.
- Background: PubMed 33604795Cortes-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.
- Results publication: PubMed 39459868Puigdellivol-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.
- Results publication: PubMed 40508884Puigdellivol-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Puigdellívol-Sánchez, Ph D principal investigator
Consorci Sanitari de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19 and Influenza Vaccination, run by Consorci Sanitari de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Puigdellívol-Sánchez, Ph.D. (34-93-5884555, apuigdellivol@cst.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital output (time frame: from March 1, 2020.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367883, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.