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.
Study Type
OBSERVATIONAL
Enrollment
15
Hôpital Pellegrin
Bordeaux, France
Hôpital Bichat
Paris, France
La Pitié Salpêtrière
Paris, France
Time to first virologic detection (X0/E0→P0)
Time from enrolment (X0/E0) to first detectable ANDV RNA (P0)
Time frame: 6 weeks
Blood viral kinetics (trajectory endpoints)
Viral load trajectories in blood, including peak, slope of increase/decrease, and time to clearance.
Time frame: 6 weeks
Post-symptom RT-qPCR persistence
Duration of RT-qPCR positivity after symptom resolution (where measured)
Time frame: 6 weeks
Serologic conversion timing
Time to IgM positivity, time to IgG positivity
Time frame: 6 weeks
Humoral immune kinetics
IgM and IgG titres over time
Time frame: 6 weeks
Longitudinal immune marker trajectories
Longitudinal immune marker trajectories aligned to P0 and S0 (pre-specified panels)
Time frame: 6 weeks
Symptom onset and symptom duration
Symptom onset date (S0), symptom duration
Time frame: 6 weeks
Clinical severity and healthcare utilisation outcomes
Hospitalisation, ICU admission, organ support (as applicable), mortality (as applicable)
Time frame: 6 weeks
Standardised in-hospital severity metrics (if hospitalised; clinical data only)
WHO Ordinal Scale, SOFA score (if clinically available)
Time frame: 6 weeks
Host genetic correlates of infection and disease outcomes
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)
Time frame: 6 weeks
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