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TerminatedNCT06735612RECODEUpdated Sep 14, 2026

Respiratory Syncytial Virus Infection In Exacerbations of Chronic Obstructive Pulmonary Diasease: The RECODE Study

An observational study in Respiratory Synctial Virus, COPD and Chronic Obstructive Pulmonary Disease (COPD), sponsored by Fundacio Privada Mon Clinic Barcelona. Terminated at 1 site in Spain. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Fundacio Privada Mon Clinic Barcelona · Observational

Why this study was terminated
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.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
716
Ages
50 Years and older
Sex
All
01

Study 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). 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.
02

Conditions studied

  • Respiratory Synctial Virus
  • COPD
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Exacerbation of COPD
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 716 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Fundacio Privada Mon Clinic Barcelona is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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"

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
716 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients during the RSV season
  • Patients outside the RSV season
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1 year

07

Study locations

1 site
  • Hospital Clínic de Barcelona
    Barcelona, Spain
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06735612
Lead sponsor
Fundacio Privada Mon Clinic Barcelona
Responsible party
Sponsor
First posted
Dec 16, 2024
Start date
Dec 16, 2024
Primary completion
May 1, 2026
Completion
May 1, 2026
Last update
Sep 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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