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Filovirus DiseaseTEMBONCT07821580

Study of Filovirus Disease Morbi-mortality

An observational study of Filovirus Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Filoviruses, including Ebola and Marburg, cause hemorrhagic fevers associated with high mortality and still limited scientific literature, in particular for some rare species such as the Bundibugyo virus. Read more about this study

Who is it for?
Any age
Conditions the study is for
Filovirus Disease
How many people
10 participants
Where
1 siteFrance
Study dates
Sep 2026to Sep 2032
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: Any individual, including adults, children, minors under 18, and pregnant women, with a filovirus infection: * Either repatriated to the national territory with a virologically confirmed diagnosis * Or virologically diagnosed within the national territory

Who may be able to join

  • Confirmed filovirus disease
  • Hospitalized in a Referenced Healthcare Facility in France
  • Non inclusion criteria :
  • Refusal by the patient or their legal representative to sign the consent form for the study
  • Patient deprived of their liberty or subject to a legal protection measure

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site
  • Hôpital Saint Antoine

    Paris, 75012

    Marie JASPARD, MD, 06 58 80 90 12, marie.jaspard@aphp.fr

    Mathieu REVEST, MD, +33299289564, Matthieu.REVEST@chu-rennes.fr

Other trials in France

About this study

Official title: Prospective Observational Study of the Mortality of Patients With Filovirus Disease

Filoviruses, including Ebola and Marburg, cause hemorrhagic fevers associated with high mortality and still limited scientific literature, in particular for some rare species such as the Bundibugyo virus. The current epidemic of Bundibugyo virus disease in the Democratic Republic of the Congo (DRC) and Uganda, which has been declared a public health emergency of international concern by the World Health Organization (WHO), illustrates the importance of better characterizing this infection, whose genetic specificities complicate the transposition of diagnostic, therapeutic and vaccine tools developed for Ebola Zaire.

Given the incubation time of filoviruses and international mobility, cases can be diagnosed and managed outside of epidemic areas, including in exposed caregivers. However, clinical, biological and therapeutic knowledge available in this context remain very limited.

Read more

This situation justifies the implementation of an observational cohort of patients with a confirmed filovirus disease, who have arrived or were diagnosed in France.

This cohort will describe the clinical evolution of the disease, its prognosis and its pathophysiology, as well as identify new diagnostic, therapeutic or preventive leads.

Read the detailed description

Filoviruses, including Ebola Zaire, Sudan, Bundibugyo, Tai Forest and Marburg virus, are responsible for haemorrhagic fevers with high overall mortality: a recent meta-analysis reports an average case fatality rate of 59%, with extremes of 20 to 90% depending on the epidemic. Between 1976 and 2014, about twenty epidemics of filoviruses diseases (FVD) occurred in Central Africa, without much scientific documentation. The largest ever is an outbreak of Ebola virus disease (EVD) declared in West Africa between 2014 and 2016 (in Guinea, Liberia, and Sierra Leone) and recorded 11,310 deaths for 28,616 cases. Currently, an outbreak of Bundibugyo virus disease (BVD) is active in the Democratic Republic of Congo (DRC) (Ituri and North Kivu provinces) and Uganda.

It was declared a "public health emergency of international concern" by the World Health Organization (WHO) on May 17, 2026. It currently has 399 deaths out of 1333 cases reported as of June 29, 2026, reflecting the scale of the outbreak. Bundibugyo virus (BDBV) was first identified in 2007 in Uganda. The epidemic is only the third documented emergence of BVD, following those observed in Uganda in 2007 and in the DRC in 2012. The lethality of BVD is estimated to be approximately 25%. Genetically, BDBV is different from the most common species, the Zaire Ebola virus (EBOV), in a proportion of about 40%. This genetic distance explains the difficulties in adapting diagnostic approaches (molecular biology) and therapeutic approaches (monoclonal antibodies, direct-acting antivirals, and vaccines) developed for EBOV.

By the incubation period, in the order of 2 to 21 days, and the ease of air travel in the 21st century, we can expect that cases of FVD are diagnosed and treated outside of epidemic areas (in particular the healthcare staff working in epidemic areas and contaminated in a nosocomial way). During previous filovirus epidemics, a very small number of infected people were treated outside the epidemic areas. Therefore, little is known to date about the clinical and biological characteristics and the treatment history of filovirus diseases in patients managed outside the African context.

In this context, it is necessary to set up an observational cohort study of any case of disease with proven filovirus that arrived or was diagnosed in the national territory in order to describe the disease, its clinical course, prognosis, as well as to study its pathophysiology to identify new targets for the diagnosis and curative and preventive treatment.

Knowledge on filovirus diseases acquired during the care of patients with EVD outside of epidemic areas are very fragmented and the absence of biological collections taken from the few patients with EVD in previous epidemics and hospitalized in Europe or the United States did not allow us to describe interactions between the host and the pathogenic species, this being particularly true for rare strains such as the BDBV. Given the genetic distance between species, and that this is the largest epidemic to date caused by the Bundibugyo species, BVD may have clinical, biological, and prognostic features different from other filoviruses.

Keywords
filovirus, Bundibugyo virus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07821580
Study groupRoleWhat they receive
Patients with a confirmed filovirus diseaseAny individual, adult or minor, including pregnant women, suffering from a filovirus disease and responding to one of the following situations: * person repatriated to the national territory with a confirmed virological diagnosis * person who has received a virologically confirmed diagnosis in France

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vital status on day 28.

    The objective is to describe mortality at day 28 in patients with confirmed filovirus diseases.

    Day 1 is the day of the first documented positive PCR, regardless of the location of the PCR.

    Measured: 28 days

Secondary outcomes (10)
  1. Symptoms collected daily until discharge from hospitalization

    The aim is to describe the natural history of the disease

    Measured: 12 months

  2. All-cause mortality at day 90

    The objective is to describe mortality on day 90

    Measured: 90 days

  3. Failure of at least one organ requiring intensive care between D1 and D90 or death

    The objective is to identify the factors associated with a severe form of the disease (failure of at least one organ requiring management in intensive care) and death.

    Measured: 90 days

  4. Dosage of supportive care received up to day 28 or hospital discharge

    The objective is to describe the supportive care received by patients as part of the care

    Measured: 28 days

  5. Duration of supportive care administered through Day 28 or hospital discharge

    The objective is to describe the supportive care received by patients as part of the care

    Measured: 28 days

  6. Drug administered through Day 28 or hospital discharge

    The objective is to describe the supportive care received by patients as part of the care

    Measured: 28 days

  7. Vital status on day 28 by subgroups: patients who have received or have not received antiviral and/or immunomodulatory tests

    The objective is to describe the response in terms of mortality according to the specific treatments received (antiviral and/or immunomodulator).

    Measured: 28 days

  8. Quantitative viral load at each assessment time point : blood, urine, saliva, vaginal fluid, semen

    The objective is to study the viral kinetics in blood and other biological samples

    Measured: 12 months

  9. Assessment of innate and adaptive immune responses at each available time point, including M6 and M12.

    The objective is to characterize host responses to understand its pathogenesis, including innate immune responses and acquired, circulating levels of immune signaling molecules in peripheral blood to identify new diagnostic and prognostic biomarkers as well as potential therapeutic avenues.

    Measured: 12 months

  10. Assessment of circulating levels of immune signaling molecules in peripheral blood, at each available time point, particularly at M6 and M12.

    The objective is to characterize host responses to understand its pathogenesis, including innate immune responses and acquired, circulating levels of immune signaling molecules in peripheral blood to identify new diagnostic and prognostic biomarkers as well as potential therapeutic avenues.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2031 (estimated)
  4. Study completionSep 2032 (estimated)

Resources

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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07821580
Sponsor's protocol ID
APHP260973
Other IDs
2026-A01690-51
Acronym
TEMBO
Status last verified
Aug 2026
First submitted
28 Aug 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Filovirus Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 5 inclusion and 0 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: opening soon, as of the sponsor's last update on 16 Sep 2026. 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 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?

Contact Marie JASPARD, MD (06 58 80 90 12, marie.jaspard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vital status on day 28. (time frame: 28 days). 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 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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