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NCT Number: NCT07703579

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Andes Hantavirus Bunyaviridae Infections Hantavirus Infections Hantavirus Pulmonary Syndrome Infections RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pellegrin, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

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

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.:
  • 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.
  • 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.
  • 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

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

Treatment and study plan

Primary outcomes

  1. Time to first virologic detection (X0/E0→P0)

    Time frame: 6 weeks

    Time from enrolment (X0/E0) to first detectable ANDV RNA (P0)

  2. Blood viral kinetics (trajectory endpoints)

    Time frame: 6 weeks

    Viral load trajectories in blood, including peak, slope of increase/decrease, and time to clearance.

  3. Post-symptom RT-qPCR persistence

    Time frame: 6 weeks

    Duration of RT-qPCR positivity after symptom resolution (where measured)

  4. Serologic conversion timing

    Time frame: 6 weeks

    Time to IgM positivity, time to IgG positivity

Secondary outcomes

  1. Humoral immune kinetics

    Time frame: 6 weeks

    IgM and IgG titres over time

  2. Longitudinal immune marker trajectories

    Time frame: 6 weeks

    Longitudinal immune marker trajectories aligned to P0 and S0 (pre-specified panels)

  3. Symptom onset and symptom duration

    Time frame: 6 weeks

    Symptom onset date (S0), symptom duration

  4. Clinical severity and healthcare utilisation outcomes

    Time frame: 6 weeks

    Hospitalisation, ICU admission, organ support (as applicable), mortality (as applicable)

  5. Standardised in-hospital severity metrics (if hospitalised; clinical data only)

    Time frame: 6 weeks

    WHO Ordinal Scale, SOFA score (if clinically available)

  6. Host genetic correlates of infection and disease outcomes

    Time frame: 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)

Other outcomes

  1. Multi-compartment detection and shedding dynamics

    Time frame: 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).

  2. Trigger-aligned serology endpoints (P0/S0 anchored)

    Time frame: 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)

  3. Immune "inflection points" and trajectory phenotypes

    Time frame: 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.

  4. Time-to-event progression endpoints

    Time frame: 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.

  5. Daily monitoring signal summaries

    Time frame: 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. Convalescence and longer-term outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • International Severe Acute Respiratory and Emerging Infection Consortium

Registry information

Official study title

Longitudinal Observational Study of the Natural History of Andes Virus Infection

Acronym: NAVIS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

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

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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.

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