Respiratory Synctial VirusRECODENCT06735612
Respiratory Syncytial Virus Infection In Exacerbations of Chronic Obstructive Pulmonary Diasease: The RECODE Study
An observational study of Respiratory Synctial Virus and COPD, run by Fundacio Privada Mon Clinic Barcelona at 1 site in Spain.
Trial summary
The goal of this observational study is to determine the prevalence of respiratory syncytial virus (RSV) infection and evaluate its association with clinical outcomes in patients with chronic obstructive pulmonary disease (COPD) who experience exacerbations during the RSV season (October-April). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Respiratory Synctial Virus, COPD, Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 716 participants
- Where
- 1 siteSpain
- Study dates
- 16 Dec 2024to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the presence of RSV infection (RSV+ considered as cases and RSV- considered as controls) in ECOPD at the Emergency Room or Day Hospital facilities.
Who may be able to join
- Female or male
- ≥50 years of age
- Seeking urgent medical attention because of ECOPD, as defined by the Rome consensus definition: "in a patient with COPD, an exacerbation is an event characterized by dyspnea and/or cough and sputum that worsen over <14 d, which may be accompanied by tachypnoea and/or tachycardia and is often associated with increased local and systemic inflammation caused by airway infection, pollution, or other insult to the airways"
Who cannot join
- Previous RSV vaccination (other vaccines will be allowed and recorded)
- Active cancer (or any other disease) that may alter the immune status of the patient
- Neurologic disorders that incapacitate the participation of the patient
- No signing of the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to determine the prevalence of respiratory syncytial virus (RSV) infection and evaluate its association with clinical outcomes in patients with chronic obstructive pulmonary disease (COPD) who experience exacerbations during the RSV season (October-April). The main question it aims to answer is:
- What is the prevalence of RSV infection in patients with COPD during exacerbations in the RSV season?
- Does RSV infection lead to worse clinical outcomes, including hospitalization, longer length of stay, acute cardiovascular events, and/or death in patients with COPD exacerbations?
Read more
Researchers will compare patients with RSV infection to those without RSV infection to see if RSV infection results in worse clinical outcomes, such as increased hospitalization, longer stays, cardiovascular events, or death.
Participants will:
- Be adults diagnosed with COPD who present to the emergency department or day hospital due to acute exacerbations of their respiratory symptoms.
- Receive treatment as per standard clinical care for COPD exacerbations, including long-acting bronchodilators and inhaled corticosteroids, and may complete a course of antibiotics and/or oral corticosteroids if prescribed during hospitalization.
- Undergo diagnostic testing for RSV infection as part of the clinical routine to determine the presence or absence of the virus during their exacerbation.
- Have clinical outcomes monitored, including hospitalization rate, length of stay, and any acute cardiovascular events, as well as mortality during the exacerbation period.
- Provide relevant demographic and clinical data, including medical history, COPD severity, comorbidities, and previous exacerbation events.
- Conditions
- Respiratory Synctial Virus, COPD, Chronic Obstructive Pulmonary Disease (COPD), Exacerbation of COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients during the RSV season | Not described | |
| Patients outside the RSV season | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence of RSV infection because of ECOPD during the RSV season (October-April).
To determine the prevalence of RSV infection (defined as the detection of RSV by RT PCR in nasopharyngeal swab, saliva or sputum samples) among COPD patients seeking acute medical attention in the Emergency Room or Day Hospital facilities because of ECOPD during the RSV season (October-April).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start16 Dec 2024
- Primary completion1 May 2026
- Study completion1 May 2026
Why it stopped: After extending RECODE recruitment for a second year due to low enrolment, the Sponsor closed it on 1 May 2026, after the second RSV season, with 716/892 patients. Further non-RSV recruitment offered limited value; there were no safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Synctial VirusStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 716 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Privada Mon Clinic Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735612
- Sponsor's protocol ID
- RECODE
- Acronym
- RECODE
- Status last verified
- Sep 2026
- First submitted
- 11 Dec 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agusti A, Menendez R, Salamanca E, Turriani E, Martinon-Torres F. Respiratory syncytial virus infection in COPD exacerbations: the RECODE study protocol. BMJ Open. 2026 Jul 20;16(7):e119939. doi: 10.1136/bmjopen-2026-119939.
PubMed 42476737
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Syncytial Virus Infection In Exacerbations of Chronic Obstructive Pulmonary Diasease: The RECODE Study
- ClinicalTrials.gov ID
- NCT06735612
- Acronym / sponsor ID
- RECODE / RECODE
- Conditions
- Respiratory Synctial Virus, COPD, Chronic Obstructive Pulmonary Disease (COPD), Exacerbation of COPD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: After extending RECODE recruitment for a second year due to low enrolment, the Sponsor closed it on 1 May 2026, after the second RSV season, with 716/892 patients. Further non-RSV recruitment offered limited value; there were no safety concerns.
- Enrolment
- 716 participants (actual)
- Lead sponsor
- Fundacio Privada Mon Clinic BarcelonaUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 16 Dec 2024 (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.
The goal of this observational study is to determine the prevalence of respiratory syncytial virus (RSV) infection and evaluate its association with clinical outcomes in patients with chronic obstructive pulmonary disease (COPD) who experience exacerbations during the RSV season (October-April). The main question it aims to answer is:
- What is the prevalence of RSV infection in patients with COPD during exacerbations in the RSV season?
- Does RSV infection lead to worse clinical outcomes, including hospitalization, longer length of stay, acute cardiovascular events, and/or death in patients with COPD exacerbations?
Researchers will compare patients with RSV infection to those without RSV infection to see if RSV infection results in worse clinical outcomes, such as increased hospitalization, longer stays, cardiovascular events, or death.
Participants will:
- Be adults diagnosed with COPD who present to the emergency department or day hospital due to acute exacerbations of their respiratory symptoms.
- Receive treatment as per standard clinical care for COPD exacerbations, including long-acting bronchodilators and inhaled corticosteroids, and may complete a course of antibiotics and/or oral corticosteroids if prescribed during hospitalization.
- Undergo diagnostic testing for RSV infection as part of the clinical routine to determine the presence or absence of the virus during their exacerbation.
- Have clinical outcomes monitored, including hospitalization rate, length of stay, and any acute cardiovascular events, as well as mortality during the exacerbation period.
- Provide relevant demographic and clinical data, including medical history, COPD severity, comorbidities, and previous exacerbation events.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients during the RSV season | – | – |
| Patients outside the RSV season | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the presence of RSV infection (RSV+ considered as cases and RSV- considered as controls) in ECOPD at the Emergency Room or Day Hospital facilities.
Key inclusion criteria (3 listed)
- Female or male
- ≥50 years of age
- Seeking urgent medical attention because of ECOPD, as defined by the Rome consensus definition: "in a patient with COPD, an exacerbation is an event characterized by dyspnea and/or cough and sputum that worsen over <14 d, which may be accompanied by tachypnoea and/or tachycardia and is often associated with increased local and systemic inflammation caused by airway infection, pollution, or other insult to the airways"
Key exclusion criteria (4 listed)
- Previous RSV vaccination (other vaccines will be allowed and recorded)
- Active cancer (or any other disease) that may alter the immune status of the patient
- Neurologic disorders that incapacitate the participation of the patient
- No signing of the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the prevalence of RSV infection because of ECOPD during the RSV season (October-April).
Time frame: 1 year
To determine the prevalence of RSV infection (defined as the detection of RSV by RT PCR in nasopharyngeal swab, saliva or sputum samples) among COPD patients seeking acute medical attention in the Emergency Room or Day Hospital facilities because of ECOPD during the RSV season (October-April).
Results and safety
The study was stopped early (reason given: After extending RECODE recruitment for a second year due to low enrolment, the Sponsor closed it on 1 May 2026, after the second RSV season, with 716/892 patients. Further non-RSV recruitment offered limited value; there were no safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 42476737Agusti A, Menendez R, Salamanca E, Turriani E, Martinon-Torres F. Respiratory syncytial virus infection in COPD exacerbations: the RECODE study protocol. BMJ Open. 2026 Jul 20;16(7):e119939. doi: 10.1136/bmjopen-2026-119939.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Respiratory Synctial Virus and COPD, run by Fundacio Privada Mon Clinic Barcelona 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Sep 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?
The study was stopped early (reason given: After extending RECODE recruitment for a second year due to low enrolment, the Sponsor closed it on 1 May 2026, after the second RSV season, with 716/892 patients. Further non-RSV recruitment offered limited value; there were no safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of RSV infection because of ECOPD during the RSV season (October-April). (time frame: 1 year). 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 NCT06735612, which also lists 1 linked publication.
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 14 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.