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| Name | Class |
|---|---|
| International Severe Acute Respiratory and Emerging Infection Consortium | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Time to first virologic detection (X0/E0→P0) | Time from enrolment (X0/E0) to first detectable ANDV RNA (P0) | 6 weeks |
| Blood viral kinetics (trajectory endpoints) | Viral load trajectories in blood, including peak, slope of increase/decrease, and time to clearance. | 6 weeks |
| Post-symptom RT-qPCR persistence | Duration of RT-qPCR positivity after symptom resolution (where measured) | 6 weeks |
| Serologic conversion timing | Time to IgM positivity, time to IgG positivity | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immune kinetics | IgM and IgG titres over time | 6 weeks |
| Longitudinal immune marker trajectories | Longitudinal immune marker trajectories aligned to P0 and S0 (pre-specified panels) |
| Measure | Description | Time Frame |
|---|---|---|
| Multi-compartment detection and shedding dynamics | 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). |
Inclusion Criteria:
No age restriction.
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:
Direct physical exposure to a person with ANDV infection
Environmental and proximity exposure to a person with ANDV infection, i.e.:
Occupational or caregiving exposure
Ability to comply with confinement sampling and follow up procedures.
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:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pellegrin | Bordeaux | 75018 | France | |||
| Hôpital Bichat |
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.
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| ID | Term |
|---|---|
| D018804 | Hantavirus Pulmonary Syndrome |
| ID | Term |
|---|---|
| D018778 | Hantavirus Infections |
| D002044 | Bunyaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| 6 weeks |
| Symptom onset and symptom duration | Symptom onset date (S0), symptom duration | 6 weeks |
| Clinical severity and healthcare utilisation outcomes | Hospitalisation, ICU admission, organ support (as applicable), mortality (as applicable) | 6 weeks |
| Standardised in-hospital severity metrics (if hospitalised; clinical data only) | WHO Ordinal Scale, SOFA score (if clinically available) | 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) | 6 weeks |
| 6 weeks |
| Trigger-aligned serology endpoints (P0/S0 anchored) | 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 | 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 | 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 | 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 | 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 |
| Paris |
| 75018 |
| France |
| La Pitié Salpêtrière | Paris | 75018 | France |
| D007239 |
| Infections |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |