Ebola Virus DiseaseNCT04409405
Evaluation and Support to EVD Cured Patients and Their Contacts (Les Vainqueurs d'Ebola)
An observational study of Ebola Virus Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in Democratic Republic of the Congo.
Trial summary
Ebola virus is one of the most dangerous human pathogens and is an emerging public health problem in sub-Saharan Africa. Ebola virus disease (EVD) first appeared in 1976. The current epidemic in the Democratic Republic of the Congo (DRC) is one of the largest and most complex ever recorded, and is not yet under… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- How many people
- 787 participants
- Where
- 4 sitesDemocratic Republic of the Congo
- Study dates
- 16 Apr 2020to 18 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cured patients: study team will approach every declared-cured EBOV-infection patients discharged of a Ebola treatment center (Beni, Butembo, Mambassa or Mangina), older than 5 year old Contact participants: Cured participants will identify contact with who they were in contact when ill.
Who may be able to join
- In cured population
- Age ≥ 5 years
- Adults and children after an acute episode declared cured of biologically confirmed Ebola virus disease (two negative PCRs are required at least 24 hours apart so that a patient without clinical symptoms can leave the Ebola treatment center),
- Informed consent signed by at least one of the two parents or the legal guardian authorizing the child's participation in the study,
- Volunteer participant who signed the informed consent for adults.
- In CONTACT population
Show all 16Show fewer
- Age ≥ 5 years,
- Be a contact person of a cured patient (ie patient with a proven EVD, and with two negative PCRs at least 24 hours apart) included in the cohort of Ebola Winners. Based on WHO recommendations and the Centers for Disease Control and Prevention for the identification and traceability of contact subjects: a contact person is defined as a person who encountered the index case during his EVD in his residence, ie having the same place of life as him,
- Have not been diagnosed with EVD,
- Participation agreement:
- For adult participants (≥ 18 years old, emancipated or married): informed consent intended for the adult participant signed,
- For minors ≥ 5 years old: informed consent intended for the parent(s)/legal guardian signed by at least one of the two parents or the legal guardian and assent form intended for the minor participant completed.
- In cellular immunological sub-study:
- Adult participants in the parent study ≥ 18 years old,
- Accept to participate in this sub-study
- Negative blood EBOV PCR
Who cannot join
- Absence of possible follow-up over 12 months from a logistical or geographical point of view (only for cured patients);
- Non-residents in the DRC;
- Impossibility of complying with the requirements and procedures of the study in the opinion of the investigator;
- Inability to consent.
Trial locations and contacts
4 sites in 1 country.
Democratic Republic of the Congo4 sites
Beni Hospital
Beni
Mangina Hospital
Beni
Butembo Hospital
Butembo
Mambasa Hospital
Mambasa
About this study
Official title: Evaluation and Support to Ebola Virus Disease Cured Patients and Their Contacts in the Democratic Republic of the Congo
Ebola virus is one of the most dangerous human pathogens and is an emerging public health problem in sub-Saharan Africa. Ebola virus disease (EVD) first appeared in 1976. The current epidemic in the Democratic Republic of the Congo (DRC) is one of the largest and most complex ever recorded, and is not yet under control: a new death has been reported on April 10th, 2020. The epidemic was declared a public health emergency of international scope by the World Health Organization (WHO) on July 17th, 2019.
Two studies are the "standard" in the assessment of the consequences of infection in survivors, in Liberia (PREVAIL) and Guinea (PostEbogui), especially in:
Read more
- The observation of comparable mortality rates, even if over time there was an improvement in survival, probably linked to the improvement in the quality of care and symptomatic treatment;
- And the study of the contacts of the survivors, between 4 to 10% of them had done seroconversion with regard to Ebola virus (EBOV) in an asymptomatic or pauci-symptomatic way and that this rate varied according to the degree of exposure to the risk.
The DRC's experience in this area and the enormous progress made in the fight against Viral hemorrhagic fevers (VHFs), therapeutically and preventively (where much of which patients have benefited from antiviral treatment or monoclonal antibodies), the technological responses (real-time sequencing of Ebola strains in new cases, vaccination or the use of individual isolation units), show the limits of their effectiveness. A large number of questions therefore remain unanswered:
- The antibody profile of the survivors, in particular the repertoire of immunoglobulin G (IgG) specific to these individuals and its correlation with survival and its evolution over time;
- The impact of treatments initiated during the acute phase on these immune abnormalities;
- Finally, genetic factors linked to the host could play an important role in the response to the Ebola virus.
The aim of this study is to provide a better overall understanding of Ebola virus infection and its clinical, virological, and immunological consequences, of cured people and their contacts; strengthen multidisciplinary monitoring of patients after an acute phase of EVD. The results will therefore have a direct impact on the clinical management of this population and on the prevention of possible secondary contamination in the Democratic Republic of the Congo.
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola, Democratic Republic of the Congo, DRC, Ituri, North Kivu
- Medical subject headings
- Hemorrhagic Fever, Ebola
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 |
|---|---|---|
| Cured population | • Age ≥ 5 year old | |
| Contact population | * Age ≥ 5 year old * Contact of a participant included in cured-population cohort * Not diagnosed with EVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cured-participant population co-infections
Frequencies of co-infections (human immunodeficiency virus, hepatitis B virus, hepatitis C virus)
Measured: Baseline (BL)
Cured-participant population co-morbidities at any time in the study
Frequencies of co-morbidities including severity
Measured: Baseline (BL), month 3, month 6, month 9, month 12, month 18
Evolution over time of clinical consequences in cured participants
Sequelae of EVD in cured participants and their evolution according to clinical characteristics and received treatment during hospitalisation.
Measured: Baseline (BL), month 3, month 6, month 9, month 12, month 18
Evolution over time of immunological consequences in cured participants
Proportion and evolution of IgG subclasses against nucleoprotein, VP40 and glycoprotein from isolates Mayinga1976 and Kissidougou-Makona2014.
Measured: Baseline (BL), month 6, month 12
Evolution over time of virological consequences in cured participants
Evolution of EBOV virus identified by polymerase chain reaction (PCR) in biological samples (blood, urine, feces, saliva, tears, breast milk (breastfeeding women), genital secretions (women aged 15 and over) and sperm (men aged 15 and over)).
Measured: Baseline (BL), month 3, month 6, month 9, month 12, month 18
Description of contact-participants Ebola-virus-exposure risk
Description of exposure to the confirmed index case (duration and repetition of exposure, possible protection used, state of contagiousness of the confirmed index case including clinical condition and viremia), prevalence of EVD (living or deceased, with whom the subject was in contact), vaccination status against EVD.
Measured: Baseline (BL)
Asymptomatic or pauci-symptomatic Ebola infections in contact participants (clinical assessment)
Clinical assessment for EBOV infection since contact exposure to EVD patient.
Measured: Baseline (BL)
Asymptomatic or pauci-symptomatic Ebola infections in contact participants (immunological assessment)
Titration of IgG subclasses against nucleoprotein, VP40 and glycoprotein.
Measured: Baseline (BL)
Asymptomatic or pauci-symptomatic Ebola infections in contact participants (virological assessment)
Presence of Ebola virus identified by PCR in biological samples (blood, urine, feces, saliva, tears, breast milk (breastfeeding women), genital secretions and sperm (men aged 15 and over)).
Measured: Baseline (BL)
Evolution over time of peripheral blood mononuclear cells (PBMC) in cured and contact participants (cellular immunological sub-study)
Phenotypic characterization and activation status of the different cell populations within PBMC (T cells, B cells, natural killer cells, dendritic cells, etc.) by flow cytometry
Measured: Baseline (BL), month 6, month 12
Evolution over time of concentration of immune response analytes in cured and contact participants (cellular immunological sub-study)
Titration of analytes involved in immune responses (using Luminex technology)
Measured: Baseline (BL), month 6, month 12
Evolution over time of EBOV-specific T responses in cured and contact participants (cellular immunological sub-study)
EBOV-specific T responses after stimulation of cells by flow cytometry
Measured: Baseline (BL), month 6, month 12
Evolution over time of gene-expression profile in cured and contact participants (cellular immunological sub-study)
Analysis of gene-expression profile in whole blood using Ilumina technology
Measured: Baseline (BL), month 6, month 12
Evolution over time of genetic heterogeneity in cured and contact participants (cellular immunological sub-study)
Single-cell analysis to evaluate cellular genetic heterogeneity in cell population.
Measured: Baseline (BL), month 6, month 12
Genetic sub-study in cured and contact participants
Research of genetic variants implied in EBOV-infection response.
Measured: Baseline (BL)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start16 Apr 2020
- Primary completion18 Oct 2021
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- 787 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Institut de Recherche pour le Developpement
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409405
- Sponsor's protocol ID
- C19-59
- Other IDs
- ESP/CE/287/2019
- Status last verified
- Feb 2022
- First submitted
- 14 Apr 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dilu-Keti A, Tovar-Sanchez T, Cuer B, Nkuba-Ndaye A, Mukadi-Bamuleka D, Panzi-Kalunda E, Kitenge-Omasumbu R, Bulabula-Penge J, Mambu-Mbika F, Mbala-Kingebeni P, Ayouba A, Muyembe-Tamfum JJ, Etard JF, Chenge F, Delaporte E, Ahuka-Mundeke S; 'Les Vainqueurs d'Ebola' study group. Long-term Sequelae in Ebola Virus Disease Survivors Receiving Anti-Ebola Virus Therapies in the Democratic Republic of the Congo: A Prospective Cohort Study. Open Forum Infect Dis. 2025 Jul 31;12(8):ofaf436. doi: 10.1093/ofid/ofaf436. eCollection 2025 Aug.
PubMed 40809394Nkuba-Ndaye A, Dilu-Keti A, Tovar-Sanchez T, Diallo MSK, Mukadi-Bamuleka D, Kitenge R, Formenty P, Legand A, Edidi-Atani F, Thaurignac G, Pelloquin R, Mbala-Kingebeni P, Toure A, Ayouba A, Muyembe-Tamfum JJ, Delaporte E, Peeters M, Ahuka-Mundeke S; Les Vainqueurs d'Ebola Study Group. Effect of anti-Ebola virus monoclonal antibodies on endogenous antibody production in survivors of Ebola virus disease in the Democratic Republic of the Congo: an observational cohort study. Lancet Infect Dis. 2024 Mar;24(3):266-274. doi: 10.1016/S1473-3099(23)00552-2. Epub 2023 Nov 30.
PubMed 38043556
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Support to Ebola Virus Disease Cured Patients and Their Contacts in the Democratic Republic of the Congo
- ClinicalTrials.gov ID
- NCT04409405
- Acronym / sponsor ID
- C19-59
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola, Democratic Republic of the Congo, DRC, Ituri, North Kivu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 787 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Institut de Recherche pour le Developpement
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 1 Jun 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.
Ebola virus is one of the most dangerous human pathogens and is an emerging public health problem in sub-Saharan Africa. Ebola virus disease (EVD) first appeared in 1976. The current epidemic in the Democratic Republic of the Congo (DRC) is one of the largest and most complex ever recorded, and is not yet under control: a new death has been reported on April 10th, 2020. The epidemic was declared a public health emergency of international scope by the World Health Organization (WHO) on July 17th, 2019.
Two studies are the "standard" in the assessment of the consequences of infection in survivors, in Liberia (PREVAIL) and Guinea (PostEbogui), especially in:
- The observation of comparable mortality rates, even if over time there was an improvement in survival, probably linked to the improvement in the quality of care and symptomatic treatment;
- And the study of the contacts of the survivors, between 4 to 10% of them had done seroconversion with regard to Ebola virus (EBOV) in an asymptomatic or pauci-symptomatic way and that this rate varied according to the degree of exposure to the risk.
The DRC's experience in this area and the enormous progress made in the fight against Viral hemorrhagic fevers (VHFs), therapeutically and preventively (where much of which patients have benefited from antiviral treatment or monoclonal antibodies), the technological responses (real-time sequencing of Ebola strains in new cases, vaccination or the use of individual isolation units), show the limits of their effectiveness. A large number of questions therefore remain unanswered:
- The antibody profile of the survivors, in particular the repertoire of immunoglobulin G (IgG) specific to these individuals and its correlation with survival and its evolution over time;
- The impact of treatments initiated during the acute phase on these immune abnormalities;
- Finally, genetic factors linked to the host could play an important role in the response to the Ebola virus.
The aim of this study is to provide a better overall understanding of Ebola virus infection and its clinical, virological, and immunological consequences, of cured people and their contacts; strengthen multidisciplinary monitoring of patients after an acute phase of EVD. The results will therefore have a direct impact on the clinical management of this population and on the prevention of possible secondary contamination in the Democratic Republic of the Congo.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cured population | – | –• Age ≥ 5 year old |
| Contact population | – | –* Age ≥ 5 year old * Contact of a participant included in cured-population cohort * Not diagnosed with EVD |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cured patients: study team will approach every declared-cured EBOV-infection patients discharged of a Ebola treatment center (Beni, Butembo, Mambassa or Mangina), older than 5 year old Contact participants: Cured participants will identify contact with who they were in contact when ill.
Key inclusion criteria (16 listed)
- In cured population
- Age ≥ 5 years
- Adults and children after an acute episode declared cured of biologically confirmed Ebola virus disease (two negative PCRs are required at least 24 hours apart so that a patient without clinical symptoms can leave the Ebola treatment center),
- Informed consent signed by at least one of the two parents or the legal guardian authorizing the child's participation in the study,
- Volunteer participant who signed the informed consent for adults.
Key exclusion criteria (4 listed)
- Absence of possible follow-up over 12 months from a logistical or geographical point of view (only for cured patients);
- Non-residents in the DRC;
- Impossibility of complying with the requirements and procedures of the study in the opinion of the investigator;
- Inability to consent.
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
Cured-participant population co-infections
Time frame: Baseline (BL)
Frequencies of co-infections (human immunodeficiency virus, hepatitis B virus, hepatitis C virus)
Cured-participant population co-morbidities at any time in the study
Time frame: Baseline (BL), month 3, month 6, month 9, month 12, month 18
Frequencies of co-morbidities including severity
Evolution over time of clinical consequences in cured participants
Time frame: Baseline (BL), month 3, month 6, month 9, month 12, month 18
Sequelae of EVD in cured participants and their evolution according to clinical characteristics and received treatment during hospitalisation.
Evolution over time of immunological consequences in cured participants
Time frame: Baseline (BL), month 6, month 12
Proportion and evolution of IgG subclasses against nucleoprotein, VP40 and glycoprotein from isolates Mayinga1976 and Kissidougou-Makona2014.
Evolution over time of virological consequences in cured participants
Time frame: Baseline (BL), month 3, month 6, month 9, month 12, month 18
Evolution of EBOV virus identified by polymerase chain reaction (PCR) in biological samples (blood, urine, feces, saliva, tears, breast milk (breastfeeding women), genital secretions (women aged 15 and over) and sperm (men aged 15 and over)).
Description of contact-participants Ebola-virus-exposure risk
Time frame: Baseline (BL)
Description of exposure to the confirmed index case (duration and repetition of exposure, possible protection used, state of contagiousness of the confirmed index case including clinical condition and viremia), prevalence of EVD (living or deceased, with whom the subject was in contact), vaccination status against EVD.
Asymptomatic or pauci-symptomatic Ebola infections in contact participants (clinical assessment)
Time frame: Baseline (BL)
Clinical assessment for EBOV infection since contact exposure to EVD patient.
Asymptomatic or pauci-symptomatic Ebola infections in contact participants (immunological assessment)
Time frame: Baseline (BL)
Titration of IgG subclasses against nucleoprotein, VP40 and glycoprotein.
Asymptomatic or pauci-symptomatic Ebola infections in contact participants (virological assessment)
Time frame: Baseline (BL)
Presence of Ebola virus identified by PCR in biological samples (blood, urine, feces, saliva, tears, breast milk (breastfeeding women), genital secretions and sperm (men aged 15 and over)).
Evolution over time of peripheral blood mononuclear cells (PBMC) in cured and contact participants (cellular immunological sub-study)
Time frame: Baseline (BL), month 6, month 12
Phenotypic characterization and activation status of the different cell populations within PBMC (T cells, B cells, natural killer cells, dendritic cells, etc.) by flow cytometry
Evolution over time of concentration of immune response analytes in cured and contact participants (cellular immunological sub-study)
Time frame: Baseline (BL), month 6, month 12
Titration of analytes involved in immune responses (using Luminex technology)
Evolution over time of EBOV-specific T responses in cured and contact participants (cellular immunological sub-study)
Time frame: Baseline (BL), month 6, month 12
EBOV-specific T responses after stimulation of cells by flow cytometry
Evolution over time of gene-expression profile in cured and contact participants (cellular immunological sub-study)
Time frame: Baseline (BL), month 6, month 12
Analysis of gene-expression profile in whole blood using Ilumina technology
Evolution over time of genetic heterogeneity in cured and contact participants (cellular immunological sub-study)
Time frame: Baseline (BL), month 6, month 12
Single-cell analysis to evaluate cellular genetic heterogeneity in cell population.
Genetic sub-study in cured and contact participants
Time frame: Baseline (BL)
Research of genetic variants implied in EBOV-infection response.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Results publication: PubMed 40809394Dilu-Keti A, Tovar-Sanchez T, Cuer B, Nkuba-Ndaye A, Mukadi-Bamuleka D, Panzi-Kalunda E, Kitenge-Omasumbu R, Bulabula-Penge J, Mambu-Mbika F, Mbala-Kingebeni P, Ayouba A, Muyembe-Tamfum JJ, Etard JF, Chenge F, Delaporte E, Ahuka-Mundeke S; 'Les Vainqueurs d'Ebola' study group. Long-term Sequelae in Ebola Virus Disease Survivors Receiving Anti-Ebola Virus Therapies in the Democratic Republic of the Congo: A Prospective Cohort Study. Open Forum Infect Dis. 2025 Jul 31;12(8):ofaf436. doi: 10.1093/ofid/ofaf436. eCollection 2025 Aug.
- Results publication: PubMed 38043556Nkuba-Ndaye A, Dilu-Keti A, Tovar-Sanchez T, Diallo MSK, Mukadi-Bamuleka D, Kitenge R, Formenty P, Legand A, Edidi-Atani F, Thaurignac G, Pelloquin R, Mbala-Kingebeni P, Toure A, Ayouba A, Muyembe-Tamfum JJ, Delaporte E, Peeters M, Ahuka-Mundeke S; Les Vainqueurs d'Ebola Study Group. Effect of anti-Ebola virus monoclonal antibodies on endogenous antibody production in survivors of Ebola virus disease in the Democratic Republic of the Congo: an observational cohort study. Lancet Infect Dis. 2024 Mar;24(3):266-274. doi: 10.1016/S1473-3099(23)00552-2. Epub 2023 Nov 30.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ebola Virus Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in Democratic Republic of the Congo.
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 16 inclusion and 4 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: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Democratic Republic of the Congo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cured-participant population co-infections (time frame: Baseline (BL)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04409405, which also lists 2 linked publications.
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 1 Oct 2025; AzTrials last refreshed its copy on 2 Nov 2026.