Andesvirus infection, ANDV infection, Hantavirus Pulmonary Syndrome (HPS), Hantavirus Cardiopulmonary Syndrome (HCPS) Andes virus infection
Conditions
Interventions
None listed
Sponsors
European Clinical Research Alliance on Infectious Diseases (Ecraid)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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:a. Direct physical exposure to a person with ANDV infection ( Box 1)b. Environmental and proximity exposure to a person with ANDV infection 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 4-8 hour time threshold. c. Occupational or caregiving exposureProvision 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. 3. Ability to comply with confinement sampling and follow-up procedures.4. 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
Exclusion criteria: Current imprisonment (quarantine does not count).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5.1 Primary Outcomes The primary outcomes are designed to define the core natural history timeline from exposure(X0) through first virologic detection (P0) and subsequent infection dynamics. 5.1.1 Time to first virologic detection (X0/E0?P0)Outcome: Time from enrolment (X0) to first detectable ANDV RNA (P0). Definition: P0 is the date/time of the first ANDV RT-qPCR positive result. Data source: Study RT-qPCR testing performed per Schedule of Events. 5.1.2 Blood viral kinetics (trajectory endpoints)Outcome: Viral load trajectories in blood, including peak, slope of increase/decrease, and time to clearance. Definition: Viral load is quantified by ANDV RT-qPCR in venous blood (EDTA ? buffy coat preferred, ± plasma). Summary parameters (peak, slopes, clearance timing) will be derived from longitudinal measurements. Data source: Serial blood RT-qPCR measurements collected per Schedule of Events. Clearance operationalisation: The specific rule for “viral clearance” (e.g., sustained negativity requirement) will be prespecified in the Statistical Analysis Plan (SAP). 5.1.3 Post-symptom RT-qPCR persistenceOutcome: Duration of RT-qPCR positivity after symptom resolution (where measured). Definition: Time from documented symptom resolution to the last observed RT-qPCR positive result (and/or time to clearance post-resolution), as prespecified in the SAP. Data source: RT-qPCR results linked to daily symptom monitoring and follow-up assessments. 5.1.4 Serologic conversion timingOutcome: Time to IgM positivity. Outcome: Time to IgG positivity. Definition: Time from P0 to first IgM positive and first IgG positive, respectively (additional trigger-aligned derivations may be analysed as secondary/exploratory; see below). Data source: Serology (IgM/IgG; serum) collected longitudinally per Schedule of Events. | — |
Secondary
| Measure | Time frame |
|---|---|
| 5.2.1 Humoral immune kineticsOutcome: IgM and IgG titres over time. Definition: Longitudinal titre trajectories for IgM and IgG, including time-varying patterns across phases (Tier 1–3). Data source: Repeated serology (IgM/IgG; serum) per Schedule of Events. 5.2.2 Longitudinal immune marker trajectories Outcome: Longitudinal immune marker trajectories aligned to P0 and S0 (pre-specified panels). Definition: Time-series of immune markers (including cellular phenotypes and other immune measures in PBMC-based and related panels) analysed with alignment to P0 and/or S0 to capture early inflection points. Data source: Longitudinal immunological panel (PBMCs) collected per Schedule of Events (and other immune assays described in the protocol’s biospecimen plan). 5.2.3 Symptom onset and symptom durationOutcome: Symptom onset date (S0). Outcome: Symptom duration. Definition: S0 is the first documented symptom onset during follow-up; symptom duration is the time from S0 to symptom resolution as captured in daily monitoring. Data source: Daily clinical monitoring (symptom diary + temperature + SpO2 + blood pressure + diuresis). 5.2.4 Clinical severity and healthcare utilisation outcomesOutcome: Hospitalisation. Outcome: ICU/NICU/PICU admission. Outcome: Organ support (as applicable). Outcome: Mortality (as applicable). Definition: Occurrence (and timing, where available) of each event during study follow-up, as documented through clinical evaluation pathways and medical record abstraction when care is sought. Data source: Medical record abstraction for any hospitalisations, complemented by structured clinical assessments at protocol visits. Biomarker association with clinical symptoms in RT-qPCR positive participants 5.2.5 Standardised in-hospital severity metrics (if hospitalised; clinical data only)Outcome: WHO Ordinal Scale. Outcome: SOFA score (if clinically av | — |
Countries
Australia, Canada, France, Germany, Greece, Italy, Netherlands, Philippines, South Africa, Switzerland, United Kingdom, United States
Contacts
Public ContactL.P.G. Derde
European Clinical Research Alliance on Infectious Diseases (Ecraid)
Outcome results
None listed