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Natural History of Andes Virus Infection (NAVIS)

8 luglio 2026 aggiornato da: Assistance Publique - Hôpitaux de Paris

Longitudinal Observational Study of the Natural History of Andes Virus Infection

This is a longitudinal observational cohort study enrolling individuals with a defined exposure to Andes Virus (ANDV) who are confined or quarantined. Subjects can be included in one of the three tiers and are all followed from one tier to the other and/or to end of quarantine: (a) Tier 1 (Exposure/Enrolment): from X0/E0 to P0 (first RT-qPCR positive); (b) Tier 2 (Pre-symptomatic infection): from P0 to S0 (first symptom onset); (c) Tier 3 (Symptomatic disease): from S0 to clinical outcome (clinical resolution or death). Epidemiological information from their exposure (X0) is also collected. The overarching goal is to delineate the natural history and the virologic and immunologic mechanisms and consequences of infection with sampling intensity matched to biological inflection points, i.e., higher frequency around P0 and symptom onset (S0) and lower intensity elsewhere. Clinical care is not directed by the protocol. All medical decisions remain under treating clinicians. This protocol remains observational and purposely low-intensity because it does not direct clinical care, and uses a trigger-based, phase-adaptive tier structure (X0/E0, P0, S0) that limits biospecimen collection to fixed, low-frequency schedules (generally 1-2 collection days/week with step-down to 1 day/week in weeks 5-6 post-trigger) while daily follow-up is restricted to non-invasive clinical monitoring. Participation in the NAVIS protocol does not restrict or prevent enrollment in other Hantavirus-related emergency responses or interventional clinical trials.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Tipo di studio

Osservativo

Iscrizione (Effettivo)

15

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Bordeaux, Francia, 75018
        • Hôpital Pellegrin
      • Paris, Francia, 75018
        • Hôpital Bichat
      • Paris, Francia, 75018
        • La Pitié Salpêtrière

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Consenting persons of any age who have a confirmed exposure to Andes virus and persons with confirmed Andes virus infection who are placed under confinement or quarantine or clinical care for active Andes virus infection. Participation in the NAVIS protocol does not restrict or prevent enrollment in other Hantavirus-related emergency responses or interventional clinical trials.

Descrizione

Inclusion Criteria:

  1. No age restriction.

  2. Persons diagnosed with or exposed to Andes Virus (ANDV). Exposure must comply with the national definition of ANDV exposure in each country, or satisfy at least one of the following criteria:

    1. Direct physical exposure to a person with ANDV infection

    2. Environmental and proximity exposure to a person with ANDV infection, i.e.:

      • Prolonged presence in an enclosed or poorly ventilated shared airspace. Note: Prolonged exposure is defined as cumulative exposure of 15 minutes or more within a 24-hour period in a confined space, or shared occupancy of an enclosed environment for more than 2 hours (ECDC).
      • Co-habitation in the same household, room, or cabin (e.g., maritime or shared residential settings).
      • Documented proximity during long-haul travel exceeding 4 hours. Note: Proximity is defined as sitting in an adjacent seat, defined as the same row or within two rows in front or behind. Long haul travel includes flight, bus, car or train. See Box 2 for justification of the 4 hour time threshold.

    3. Occupational or caregiving exposure

      • Provision of direct healthcare or personal care to a person with ANDV infection without the consistent use of recommended Personal Protective Equipment (PPE).
      • Direct handling of potentially contaminated fomites, such as soiled linens, clothing, or bedding used by a confirmed case.
      • Direct handling of laboratory samples form a confirmed case with noncompliance with standard biosafety protocols.
  3. Ability to comply with confinement sampling and follow up procedures.
  4. Informed consent by participant, parent/legal guardian, or surrogate where allowed and applicable; assent or consent for children aged <18 years or <16 years as per local regulations.

Exclusion Criteria:

  • 1. Current imprisonment (quarantine does not count).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to first virologic detection (X0/E0→P0)
Lasso di tempo: 6 weeks
Time from enrolment (X0/E0) to first detectable ANDV RNA (P0)
6 weeks
Blood viral kinetics (trajectory endpoints)
Lasso di tempo: 6 weeks
Viral load trajectories in blood, including peak, slope of increase/decrease, and time to clearance.
6 weeks
Post-symptom RT-qPCR persistence
Lasso di tempo: 6 weeks
Duration of RT-qPCR positivity after symptom resolution (where measured)
6 weeks
Serologic conversion timing
Lasso di tempo: 6 weeks
Time to IgM positivity, time to IgG positivity
6 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Humoral immune kinetics
Lasso di tempo: 6 weeks
IgM and IgG titres over time
6 weeks
Longitudinal immune marker trajectories
Lasso di tempo: 6 weeks
Longitudinal immune marker trajectories aligned to P0 and S0 (pre-specified panels)
6 weeks
Symptom onset and symptom duration
Lasso di tempo: 6 weeks
Symptom onset date (S0), symptom duration
6 weeks
Clinical severity and healthcare utilisation outcomes
Lasso di tempo: 6 weeks
Hospitalisation, ICU admission, organ support (as applicable), mortality (as applicable)
6 weeks
Standardised in-hospital severity metrics (if hospitalised; clinical data only)
Lasso di tempo: 6 weeks
WHO Ordinal Scale, SOFA score (if clinically available)
6 weeks
Host genetic correlates of infection and disease outcomes
Lasso di tempo: 6 weeks
Genetic associations with infection susceptibility (i.e., infected vs. uninfected among exposed participants). disease severity/progression (e.g., severe vs. mild disease outcomes), key clinical events (e.g., hospitalisation, ICU admission, organ support, mortality) and molecular and immune markers (e.g., differences in viral load kinetics or immune response levels)
6 weeks

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Multi-compartment detection and shedding dynamics
Lasso di tempo: 6 weeks
Time-to-first-detection in each compartment (blood/buffy coat, plasma if collected, nasopharyngeal swab, saliva, urine, feces) and lead/lag structure relative to P0, compartment-specific kinetic summaries (peak, time-to-peak, growth/decay rates, and AUC) per compartment, compartment-specific time to clearance and discordance patterns (persistence in non-blood compartments after blood clearance, or vice versa).
6 weeks
Trigger-aligned serology endpoints (P0/S0 anchored)
Lasso di tempo: 6 weeks
P0→IgM+, P0→IgG+, S0→IgM+, and S0→IgG+ intervals (trigger-aligned seroconversion timing), early titre kinetic features (e.g., early rise patterns) as predictors of downstream clinical outcomes (hypothesis-generating)
6 weeks
Immune "inflection points" and trajectory phenotypes
Lasso di tempo: 6 weeks
Earliest detectable immune activation relative to P0 and relative to S0 ("immune inflection point timing"), and peak/resolution kinetics of immune markers, data-driven immune trajectory phenotypes (e.g., clustered longitudinal patterns) and their association with clinical outcomes.
6 weeks
Time-to-event progression endpoints
Lasso di tempo: 6 weeks
Time-to-event endpoints such as P0→hospitalisation/ICU and S0→hospitalisation/ICU/organ support/death (as data allow), for early risk modelling and natural history characterization.
6 weeks
Daily monitoring signal summaries
Lasso di tempo: 6 weeks
Descriptive trajectories and derived summaries of daily monitoring measures (temperature, SpO₂, blood pressure, diuresis) and their association with subsequent clinical outcomes (hypothesis-generating)
6 weeks
Convalescence and longer-term outcomes
Lasso di tempo: 6 months
Convalescence pattern descriptors and longer-term outcomes through Month 6 (and beyond if extended), including persistence or resolution patterns as captured in follow-up
6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaboratori

International Severe Acute Respiratory and Emerging Infection Consortium

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 maggio 2026

Completamento primario (Stimato)

1 agosto 2026

Completamento dello studio (Stimato)

1 agosto 2026

Date di iscrizione allo studio

Primo inviato

8 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • APHP260690

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) and the european regulation (GDPR) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sponsor e collaboratori

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
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