Active — Not RecruitingNot Applicable

Natural History of Andes Virus Infection

France15 participantsStarted 2026-05-19

Plain-language 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 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 weeks

Blood viral kinetics (trajectory endpoints)

Timeframe: 6 weeks

Post-symptom RT-qPCR persistence

Timeframe: 6 weeks

Serologic conversion timing

Timeframe: 6 weeks

Trial details

NCT IDNCT07703579

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Andes Hantavirus trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.