Andes HantavirusNAVISNCT07703579
Natural History of Andes Virus Infection
An observational study of Andes Hantavirus, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Andes Hantavirus
- How many people
- 15 participants
- Where
- 3 sitesFrance
- Study dates
- 19 May 2026to Aug 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 1. Current imprisonment (quarantine does not count).
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Pellegrin
Bordeaux, 75018
Hôpital Bichat
Paris, 75018
La Pitié Salpêtrière
Paris, 75018
About this study
Official title: 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.
- Conditions
- Andes Hantavirus
- Keywords
- Hantavirus, Andes, Natural history
- Medical subject headings
- Hantavirus Pulmonary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first virologic detection (X0/E0→P0)
Time from enrolment (X0/E0) to first detectable ANDV RNA (P0)
Measured: 6 weeks
Blood viral kinetics (trajectory endpoints)
Viral load trajectories in blood, including peak, slope of increase/decrease, and time to clearance.
Measured: 6 weeks
Post-symptom RT-qPCR persistence
Duration of RT-qPCR positivity after symptom resolution (where measured)
Measured: 6 weeks
Serologic conversion timing
Time to IgM positivity, time to IgG positivity
Measured: 6 weeks
Secondary outcomes (6)
Humoral immune kinetics
IgM and IgG titres over time
Measured: 6 weeks
Longitudinal immune marker trajectories
Longitudinal immune marker trajectories aligned to P0 and S0 (pre-specified panels)
Measured: 6 weeks
Symptom onset and symptom duration
Symptom onset date (S0), symptom duration
Measured: 6 weeks
Clinical severity and healthcare utilisation outcomes
Hospitalisation, ICU admission, organ support (as applicable), mortality (as applicable)
Measured: 6 weeks
Standardised in-hospital severity metrics (if hospitalised; clinical data only)
WHO Ordinal Scale, SOFA score (if clinically available)
Measured: 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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start19 May 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Andes HantavirusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- International Severe Acute Respiratory and Emerging Infection Consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703579
- Sponsor's protocol ID
- APHP260690
- Acronym
- NAVIS
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Study of the Natural History of Andes Virus Infection
- ClinicalTrials.gov ID
- NCT07703579
- Acronym / sponsor ID
- NAVIS / APHP260690
- Conditions
- Andes Hantavirus
- Keywords
- Hantavirus, Andes, Natural history
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- International Severe Acute Respiratory and Emerging Infection Consortium
- Study start
- 19 May 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (1 listed)
- 1. Current imprisonment (quarantine does not count).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to first virologic detection (X0/E0→P0)
Time frame: 6 weeks
Time from enrolment (X0/E0) to first detectable ANDV RNA (P0)
Blood viral kinetics (trajectory endpoints)
Time frame: 6 weeks
Viral load trajectories in blood, including peak, slope of increase/decrease, and time to clearance.
Post-symptom RT-qPCR persistence
Time frame: 6 weeks
Duration of RT-qPCR positivity after symptom resolution (where measured)
Serologic conversion timing
Time frame: 6 weeks
Time to IgM positivity, time to IgG positivity
6 secondary outcomes
Humoral immune kinetics
Time frame: 6 weeks
Longitudinal immune marker trajectories
Time frame: 6 weeks
Symptom onset and symptom duration
Time frame: 6 weeks
Clinical severity and healthcare utilisation outcomes
Time frame: 6 weeks
Standardised in-hospital severity metrics (if hospitalised; clinical data only)
Time frame: 6 weeks
Host genetic correlates of infection and disease outcomes
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Andes Hantavirus, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first virologic detection (X0/E0→P0) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.