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NCT Number: NCT04323904

Hantavirus Registry - HantaReg

Hantavirus disease are zoonotic infections and remain a clinical challenge with globally increasing incidence and multiple serious outbreak situations in Europe within the last years. Hantavirus disease encompasses two clinical syndromes, hemorrhagic fever with renal syndrome (HFRS) and hantavirus cardiopulmonary syndrome (HCPS) caused by Old World and New World hantaviruses, respectively. Depending on the causative Old World hantavirus species, clinical course of HFRS can vary from mild to moderate to severe.

At present, there is no specific therapy available for hantavirus disease. As the clinical course of hantavirus disease is dependent on the causing viral pathogen and as there worrisome hints that clinical course HFRS and HCPS overlap, further studies with regard to the disease course are mandatory. Furthermore, the examination of attributable mortality and costs of hantavirus disease will need to be studied on a multinational basis and therefore HantaReg will particularly use a matched case control design.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne

Cologne, North-Rhine Westfalia, 50937, Germany

Location status: Recruiting

Location contact

Felix Köhler, MD

CONTACT

[email protected]

Felix Köhler, MD

CONTACT

[email protected]

About this study

Hantavirus disease are zoonotic infections and remain a clinical challenge with globally increasing incidence and multiple serious outbreak situations in Europe within the last years. Hantavirus disease encompasses two clinical syndromes, hemorrhagic fever with renal syndrome (HFRS) and hantavirus cardiopulmonary syndrome (HCPS) caused by Old World and New World hantaviruses, respectively. Depending on the causative Old World hantavirus species, clinical course of HFRS can vary from mild to moderate to severe. HRFS caused by Hantaan virus, Amur virus and Dobrava-Belgrade virus lead to severe clinical course of the disease, with mortality ranging from 10-15%, whereas Seoul virus and Puumula virus result in mild to moderate from of disease with a mortality below <1%, also referred to as nephropathia epidemica. New World hantaviruses cause HCPS leading to acute respiratory distress syndrome (ARDS) and heart rhythm disorders with attributable mortality ranging high from 30-50%. However, there are hints that HRFS and HCPS overlap with a combined clinical course with cardiopulmonary, renal and hemorrhagic symptoms being present simultaneously. Due to climate changes and globalization, outbreak situations of hantavirus disease throughout Europe are increasing and there are worrisome trends regarding changing of species distributions in Europe.

At present, there is no specific therapy available for hantavirus disease. Treatment approaches are primarily supportive with admission of patients to the intensive care unit (ICU) and maintenance of fluid and electrolyte balance. Patients with severe renal insufficiency and fluid retention, pulmonary edema or hyperkalemia may require dialysis. In case of extensive thrombocytopenia and present bleeding, platelet transfusion may be needed. In HCPS, treatment approaches consist of the supplementation of oxygen, mechanical ventilation and in case of extended acute respiratory distress syndrome (ARDS) extracorporeal membrane oxygenation (ECMO).

Due to increasingly frequent outbreak situations and globally chances in species distributions, a worldwide surveillance in epidemiology and species attribution is needed. As the clinical course of hantavirus disease is dependent on the causing viral pathogen and as there worrisome hints that clinical course HFRS and HCPS overlap, further studies with regard to the disease course are mandatory. Furthermore, the examination of attributable mortality and costs of hantavirus disease will need to be studied on a multinational basis and therefore HantaReg will particularly use a matched case control design.

The objective of the Hantavirus Registry - HantaReg is to overcome the lack of knowledge on epidemiology, clinical course and prognostic factors for hantavirus infections and their complications, as well as to serve as a platform for future studies and outbreak situations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Serological or molecular evidence of hantavirus infection and clinical evidence of nephropathia epidemica or hemorrhagic fever with renal syndrome (HFRS)
  • Serological or molecular evidence of hantavirus infection and clinical evidence of hantavirus cardiopulmonary syndrome (HCPS)

Exclusion criteria

  • Serological or molecular evidence of hantavirus infection without clinical signs of nephropathia epidemica, HFRS or HCPS

Treatment and study plan

Retrospective data collection

Other

Retrospective data collection from patients with hantavirus infection and matching control group patients.

Primary outcomes

  1. Incidence

    Time frame: up to 100 weeks

    To describe the global incidence of hantavirus infections

  2. Mortality

    Time frame: up to 100 weeks

    To describe the global mortality due to hantavirus infections

Secondary outcomes

  1. Complications

    Time frame: at 90 days from diagnosis

    To describe complications of hantavirus infections

  2. Therapeutic approaches

    Time frame: at 90 days from diagnosis

    To describe therapeutic approaches of hantavirus infections

  3. First-line and salvage treatment approaches

    Time frame: at 90 days from diagnosis

    To describe first-line and salvage treatment approaches and their efficacy and impact on patients' outcome

  4. Recommendations for diagnosis and treatment

    Time frame: at 90 days from diagnosis

    To develop clinical screening and diagnostic approaches

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Köhler, MD

CONTACT

[email protected]

+4922147897222

Felix Köhler, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

Hantavirus Registry Gathers Knowledge on Epidemiology, Clinical Course, Prognostic Factors and Molecular Characteristics for Hantavirus Infections and Their Complications (HantaReg)

Acronym: HantaReg

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Mar 27, 2020
Registry last updated
Dec 17, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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