Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07239830

Interferon Reference for Older People - REFIPA Study

The diagnosis of respiratory viral infections is mainly based on PCR tests targeting the DNA or RNA of suspected viruses, including SARS-CoV-2, RSV and influenza viruses. However, this method is limited because it only tests for a small number of viruses, while many other pathogens can cause similar symptoms. As a result, respiratory viral infections are often underdiagnosed because not all possible viruses are systematically tested for.

Another limitation of PCR tests is that they can detect residual viral genetic material long after the infection has ended, making it difficult to distinguish between an active infection and a past one. Viral load can help interpret the result, but it is not always reliable. It is therefore essential to have complementary markers that can indicate whether the detected virus is still in the active replication phase.

An innovative approach is to measure the host's immune response, in particular the production of type I interferons (IFN-I), which are markers of active viral infection. Studies have shown that joint analysis of the IFN-I/III response and PCR tests improves the detection of viral respiratory infections by better discriminating between active infections. This method shows promise for refining diagnosis, particularly in cases where the viral load is low or ambiguous.

These advances are particularly important for older patients, in whom viral infections have a severe impact. Ageing leads to a decline in immune function (immunosenescence), including a reduction in IFN-I production. This alteration could further complicate the interpretation of immune biomarkers in older people, highlighting the need to establish reference values specific to this population.

In this context, the RESPIGERIA study (compliance with MR004 No. 24-5127) was launched to evaluate the IFN response in geriatric hospitalised patients with respiratory viral infections. However, there is still a lack of reference data on the IFN response in uninfected older individuals. Establishing a baseline IFN score in this population is essential in order to adapt diagnostic tools to age-related specificities.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Immunosenescence Uninfected Older

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital des Charpennes (Hospices Civils de Lyon)

Villeurbanne, 69100, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject aged 80 or over
  • Patient admitted to the Charpennes hospital day unit or outpatient clinic for follow-up OR accompanying patient who receive care at the Charpennes geriatric hospital OR subject recruited through the local press
  • Weight greater than or equal to 45 kg
  • Subject living in the Lyon metropolitan area

Exclusion criteria

  • Subjects with symptoms of active infection (symptom questionnaire or temperature > 37.5°C).
  • Subjects with an autoimmune disease linked to a dysregulated interferon response.
  • Subjects participating in another interventional study involving an exclusion period that is still ongoing or that may interfere with the present protocol.
  • Subjects deprived of their liberty by judicial or administrative decision
  • Subjects receiving psychiatric care
  • Adults subject to legal protection measures (guardianship, curatorship)
  • Subjects not affiliated with a social security scheme or beneficiaries of a similar scheme

Treatment and study plan

Uninfected older adults

Other

The procedures specifically carried out for the study during a single visit are as follows:

  • 1 nasopharyngeal swab for baseline measurement of nasal IFN score and testing for infection
  • Venous blood sampling on:
  • 1 x 2 mL Paxgene tube for baseline measurement of blood IFN score
  • 3 x 10 mL EDTA tubes for collection of PBMCs and plasma to quantify anti-IFN antibody levels and lymphocyte subtype concentrations.

A total of 32 mL of venous blood will be collected for the study during a single visit.

A biological collection will be created with the participant's specific consent, using leftover blood and nasopharyngeal swabs after testing.

Primary outcomes

  1. Nasal IFN-I scores measurement in a non-infected geriatric population.

    Time frame: The primary outcome will be measured at inclusion visit only

    IFN-I score will be measured by assessing the expression of a selection of IFN-I-stimulated genes.

  2. Blodd IFN-I scores measurement in a non-infected geriatric population.

    Time frame: The primary outcome will be measured at inclusion visit only

    IFN-I score will be measured by assessing the expression of a selection of IFN-I-stimulated genes.

Secondary outcomes

  1. Correlation between clinical parameters assessed by the Charlson score (comorbidities) and the Fried phenotype (frailty), and the basal blood and nasal interferon score

    Time frame: The secondary outcome will be measured at inclusion visit only

    We hypothesize that frailty (assessed by Frailty phenotype) and comorbidities (assessed by Charlson comorbidity index) could be associated with immunosenescence and IFN-I score.

  2. Correlation between immune parameters assessed by anti-IFN antibody concentration, concentration of lymphocyte subtypes expressing or not expressing exhaustion markers (Tim-3, PD-1, etc.) and basal blood and nasal interferon score.

    Time frame: The secondary outcome will be measured at inclusion visit only

    Spearman correlation will be done between IFN-I score and each immune parameters.

  3. Measurement of nasal IFN-I scores in a population of uninfected vs. infected older individuals (RESPIGERIA study, compliance with MR004 No. 24-5127).

    Time frame: The secondary outcome will be measured at inclusion visit only

    Comparison of the score IFN-I, measured by assessing the expression of a selection of IFN-I-stimulated genes, between the two groups of interest (uninfected vs. infected older individuals).

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine GARNIER-CRUSSARD

CONTACT

[email protected]

+33 4 72 43 20 50

Sophie TROUILLET-ASSANT

CONTACT

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Reference Values Determination of Nasal and Blood Interferon Scores in Uninfected Older Subjects REFérence Interféron Older Subjects (Older People Interferon Reference) - REFIPA Study

Acronym: REFIPA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.