CClinicalTrials.gg
Not yet recruitingNCT07813481ELREVIUpdated Sep 10, 2026

ELderly REspiratory VIral Cohort

An observational study in Influenza Viruses, Respiratory Syncytial Virus (RSV) and Severe Acute Respiratory Syndrome Coronavirus 2, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
65 Years and older
Sex
All
01

Study summary

In addition to SarsCov2, the main viral respiratory risks are associated with influenza viruses, respiratory syncytial virus (RSV), human metapneumovirus (hMPV) parainfluenza virus (PIV), adenovirus, rhinovirus, coronavirus and others. HMPV is a respiratory virus discovered in 2001. Like RSV, it appears to be a threat in terms of morbidity and mortality in susceptible populations.

Overall, viral infections can cause significant functional decline in older patients, with 67% and 25% reported to be at least temporarily housebound or bedridden, respectively. Respiratory viral infections prevent older patients from functioning and performing their daily tasks. They therefore have a significant impact on the older patients and their families. In addition, respiratory viruses are key factors in the exacerbation of chronic diseases.

The aims of this study are to provide a better understanding of the role of hMPV compared to common respiratory viruses on morbimortality, risk of dependency, quality of life alteration in older inpatients.

02

Conditions studied

  • Influenza Viruses
  • Respiratory Syncytial Virus (RSV)
  • Severe Acute Respiratory Syndrome Coronavirus 2
  • Human Metapneumovirus (hMPV)
  • Parainfluenza Virus (PIV)
  • Adenovirus
  • Rhinovirus
  • Coronavirus

Keywords

  • hMPV
  • RSV
  • PIV
  • SarsCov2
  • respiratory viruses
  • older adults
  • prognosis
  • morbidity
  • mortality
03

Who can participate

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

Study population

Patients aged >65 years with a diagnosis of acute respiratory infection and hospitalized in acute/geriatric wards

Inclusion criteria

  • Patient aged 65 years or older
  • Positive PCR from a nasopharyngeal swab for a respiratory viral pathogen as listed: Influenza A and B, SarsCov2, RSV, hMPV, Rhinovirus/Enterovirus, Adenovirus, Coronavirus (229E, HKU1, NL63, OC43), Parainfluenza Virus 1, 2, 3, 4.
  • Hospitalized in an Acute Medicine/Geriatrics Unit
  • Written informed consent from patient or his/her representative, with trusted support person, a family member or, failing that, a close friend if the person is physically unable to give his or her written consent. Patients under legal protection (guardianship, curatorship, family authorisation or future protection mandate) may be included with the consent of the legally authorised person.
  • Affiliated to a social security scheme

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate
  • Patient deprived of liberty by a judicial or administrative decision
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Older patients with respiratory viral infection

    Patients aged 65 years or older hospitalized in acute medicine or geriatric wards with an acute respiratory infection and a positive nasopharyngeal PCR test for a respiratory viral pathogen.

    Other: Respiratory viral infection

Interventions

  • OtherRespiratory viral infection

    Respiratory viral infection identified by a positive nasopharyngeal PCR test. The prognostic role of human metapneumovirus (hMPV) infection will be compared with that of other common respiratory viral infections in older hospitalized patients.

05

What researchers measure

Primary outcomes

  1. Proportion of participants with death and/or organ decompensation at Day 180

    Proportion of participants who died and/or experienced at least one major comorbidity decompensation (cardiac, renal, or respiratory) by Day 180.

    Time frame: From baseline Day 0 to Day 180

Secondary outcomes

  1. Proportion of participants who died

    Proportion of participants who died from any cause during follow-up.

    Time frame: From baseline Day 0 to Day 30, Day 180, Day 365

  2. Proportion of participants with major organ decompensation

    Proportion of participants experiencing major decompensation of pre-existing comorbidities, including cardiac, renal, or respiratory decompensation.

    Time frame: From baseline Day 0 to Day 30, Day 180, Day 365

  3. Proportion of participants with unplanned hospital readmission

    Proportion of participants experiencing an unplanned hospital readmission during follow-up.

    Time frame: From baseline Day 0 to Day 30, Day 180, Day 365

  4. Proportion of participants developing a lower respiratory tract infection

    Proportion of participants developing a lower respiratory tract infection (LRTI) following the respiratory viral infection.

    Time frame: From baseline Day 0 to Day 30

  5. Change from baseline in functional dependency assessed by ADL and/or iADL scores

    Change in functional dependency from baseline, assessed using the Activities of Daily Living (ADL) and/or Instrumental Activities of Daily Living (iADL) scores.

    Time frame: Baseline Day 0, Day 30, Day 180, Day 365

  6. Change from baseline in sarcopenia risk assessed by SARC-F score

    Change in sarcopenia risk from baseline, assessed using the SARC-F score.

    Time frame: Baseline Day 0, Day 30, Day 180, Day 365

  7. Change from baseline in quality of life assessed by EQ-5D-3L

    Change in health-related quality of life from baseline, assessed using the EQ-5D-3L questionnaire.

    Time frame: Baseline Day 0, Day 30, Day 180, Day 365

  8. Number and type of bacterial and viral co-infections

    Number and type of bacterial and viral co-infections diagnosed at the same time as, or within seven days following, the occurrence of the first respiratory viral infection.

    Time frame: Baseline Day 0 to D7

  9. Change in respiratory viral load between Day 0 and Day 7

    Change in viral load between Day 0 and Day 7 for each respiratory virus identified in study participants.

    Time frame: From Day 0 to Day 7

  10. Proportion of participants with death and/or major organ decompensation at Day 30

    Proportion of participants who died and/or experienced major organ decompensation by Day 30. This outcome will be used to assess vaccine effectiveness for vaccine-preventable respiratory viral infections.

    Time frame: From baseline Day 0 to Day 30

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07813481
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2030 (estimated)
Completion
Oct 2030 (estimated)
Last update
Sep 10, 2026

Study contacts

Giovanna Mrs MELICA, MD, PhD
Contact
giovanna.melica@aphp.fr
01 49 81 2455

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 not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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