Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ESP/CE/287/2019 | Other Identifier | EC Kinshasa School of Public Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo | OTHER |
| Institut de Recherche pour le Developpement | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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 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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cured population | • Age ≥ 5 year old | ||
| Contact population |
|
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Cured-participant population co-infections | Frequencies of co-infections (human immunodeficiency virus, hepatitis B virus, hepatitis C virus) | Baseline (BL) |
| Cured-participant population co-morbidities at any time in the study | Frequencies of co-morbidities including severity | 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. | 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. | 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)). | 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. |
Not provided
Not provided
Inclusion Criteria:
In cured population
In CONTACT population
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:
In cellular immunological sub-study:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni Hospital | Beni | Democratic Republic of the Congo | ||||
| Mangina Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40809394 | Result | 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. | |
| 38043556 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood sample Urine Saliva Tear drop Breast milk Stool Vaginal fluid Semen
| Baseline (BL) |
| Asymptomatic or pauci-symptomatic Ebola infections in contact participants (clinical assessment) | Clinical assessment for EBOV infection since contact exposure to EVD patient. | Baseline (BL) |
| Asymptomatic or pauci-symptomatic Ebola infections in contact participants (immunological assessment) | Titration of IgG subclasses against nucleoprotein, VP40 and glycoprotein. | 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)). | 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 | 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) | 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 | 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 | 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. | Baseline (BL), month 6, month 12 |
| Genetic sub-study in cured and contact participants | Research of genetic variants implied in EBOV-infection response. | Baseline (BL) |
| Beni |
| Democratic Republic of the Congo |
| Butembo Hospital | Butembo | Democratic Republic of the Congo |
| Mambasa Hospital | Mambasa | Democratic Republic of the Congo |
| Result |
| Nkuba-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. |
| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018702 | Filoviridae Infections |
| D018701 | Mononegavirales Infections |
Not provided
Not provided