Hantavirus InfectionsHantaRegNCT04323904
Hantavirus Registry - HantaReg
An observational study of Hantavirus Infections and Hemorrhagic Fever With Renal Syndrome, run by University of Cologne at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hantavirus Infections, Hemorrhagic Fever With Renal Syndrome, Nephropathia Epidemica
- What is being tested?
- Retrospective data collection
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 4 Mar 2020to Dec 2030
- 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: Patients with serological or molecular evidence of hantavirus infection and clinical evidence of nephropathia epidemica or hemorrhagic fever with renal syndrome (HFRS), or serological or molecular evidence of hantavirus infection and clinical evidence of hantavirus cardiopulmonary syndrome (HCPS). Particularly, controls will be identified retrospectively at the same hospitals that based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital).
Who may be able to join
- 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)
Who cannot join
- Serological or molecular evidence of hantavirus infection without clinical signs of nephropathia epidemica, HFRS or HCPS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Felix Köhler, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, North-Rhine Westfalia, 50937
Felix Köhler, MD, felix.koehler@uk-koeln.de
Felix Köhler, MD, kidneyinfection@uk-koeln.de
About this study
Official title: Hantavirus Registry Gathers Knowledge on Epidemiology, Clinical Course, Prognostic Factors and Molecular Characteristics for Hantavirus Infections and Their Complications (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.
Read the detailed description
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.
- Conditions
- Hantavirus Infections, Hemorrhagic Fever With Renal Syndrome, Nephropathia Epidemica, Hantavirus Cardiopulmonary Syndrome
- Being tested
- Retrospective data collection
- Medical subject headings
- Hantavirus Infections, Hemorrhagic Fever with Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective data collectionOther
Retrospective data collection from patients with hantavirus infection and matching control group patients.
| Study group | Role | What they receive |
|---|---|---|
| Hantavirus Group | Patients with cultural, serological, molecular evidence of hantavirus infection Receives: Other: Retrospective data collection | |
| Control group | Controls will be included at the same hospitals that conduced cases based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital) Receives: Other: Retrospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
To describe the global incidence of hantavirus infections
Measured: up to 100 weeks
Mortality
To describe the global mortality due to hantavirus infections
Measured: up to 100 weeks
Secondary outcomes (4)
Complications
To describe complications of hantavirus infections
Measured: at 90 days from diagnosis
Therapeutic approaches
To describe therapeutic approaches of hantavirus infections
Measured: at 90 days from diagnosis
First-line and salvage treatment approaches
To describe first-line and salvage treatment approaches and their efficacy and impact on patients' outcome
Measured: at 90 days from diagnosis
Recommendations for diagnosis and treatment
To develop clinical screening and diagnostic approaches
Measured: at 90 days from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start4 Mar 2020
- Primary completionMar 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hantavirus InfectionsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323904
- Sponsor's protocol ID
- HantaReg
- Acronym
- HantaReg
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2020
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hantavirus Registry Gathers Knowledge on Epidemiology, Clinical Course, Prognostic Factors and Molecular Characteristics for Hantavirus Infections and Their Complications (HantaReg)
- ClinicalTrials.gov ID
- NCT04323904
- Acronym / sponsor ID
- HantaReg / HantaReg
- Conditions
- Hantavirus Infections, Hemorrhagic Fever With Renal Syndrome, Nephropathia Epidemica, Hantavirus Cardiopulmonary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Mar 2020 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hantavirus Group | – | Other: Retrospective data collectionPatients with cultural, serological, molecular evidence of hantavirus infection |
| Control group | – | Other: Retrospective data collectionControls will be included at the same hospitals that conduced cases based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with serological or molecular evidence of hantavirus infection and clinical evidence of nephropathia epidemica or hemorrhagic fever with renal syndrome (HFRS), or serological or molecular evidence of hantavirus infection and clinical evidence of hantavirus cardiopulmonary syndrome (HCPS). Particularly, controls will be identified retrospectively at the same hospitals that based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital).
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Serological or molecular evidence of hantavirus infection without clinical signs of nephropathia epidemica, HFRS or HCPS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective data collectionRetrospective data collection from patients with hantavirus infection and matching control group patients. | Other | Control group, Hantavirus Group |
Primary outcome
Incidence
Time frame: up to 100 weeks
To describe the global incidence of hantavirus infections
Mortality
Time frame: up to 100 weeks
To describe the global mortality due to hantavirus infections
4 secondary outcomes
Complications
Time frame: at 90 days from diagnosis
Therapeutic approaches
Time frame: at 90 days from diagnosis
First-line and salvage treatment approaches
Time frame: at 90 days from diagnosis
Recommendations for diagnosis and treatment
Time frame: at 90 days from diagnosis
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 17 Dec 2025.
- Related informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Felix Köhler, MD contact
Volker Burst, MD principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hantavirus Infections and Hemorrhagic Fever With Renal Syndrome, run by University of Cologne at 1 site in Germany.
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 2 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Contact Felix Köhler, MD (+4922147897222, felix.koehler@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: up to 100 weeks). The study lists 2 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 17 Dec 2025.