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.
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
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.
- Conditions
- Filovirus Disease
- Keywords
- filovirus, Bundibugyo virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a confirmed filovirus disease | Any 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.
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)
Symptoms collected daily until discharge from hospitalization
The aim is to describe the natural history of the disease
Measured: 12 months
All-cause mortality at day 90
The objective is to describe mortality on day 90
Measured: 90 days
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
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
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
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
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
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
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
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.
- First posted16 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Filovirus DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of the Mortality of Patients With Filovirus Disease
- ClinicalTrials.gov ID
- NCT07821580
- Acronym / sponsor ID
- TEMBO / APHP260973
- Conditions
- Filovirus Disease
- Keywords
- filovirus, Bundibugyo virus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 16 Sep 2026 (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.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a confirmed filovirus disease | – | –Any 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (5 listed)
- Confirmed filovirus disease
- Hospitalized in a Referenced Healthcare Facility in France
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vital status on day 28.
Time frame: 28 days
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.
10 secondary outcomes
Symptoms collected daily until discharge from hospitalization
Time frame: 12 months
All-cause mortality at day 90
Time frame: 90 days
Failure of at least one organ requiring intensive care between D1 and D90 or death
Time frame: 90 days
Dosage of supportive care received up to day 28 or hospital discharge
Time frame: 28 days
Duration of supportive care administered through Day 28 or hospital discharge
Time frame: 28 days
Drug administered through Day 28 or hospital discharge
Time frame: 28 days
Vital status on day 28 by subgroups: patients who have received or have not received antiviral and/or immunomodulatory tests
Time frame: 28 days
Quantitative viral load at each assessment time point : blood, urine, saliva, vaginal fluid, semen
Time frame: 12 months
Assessment of innate and adaptive immune responses at each available time point, including M6 and M12.
Time frame: 12 months
Assessment of circulating levels of immune signaling molecules in peripheral blood, at each available time point, particularly at M6 and M12.
Time frame: 12 months
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 16 Sep 2026.
- Individual participant dataSharing planned: No
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.
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 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.