Evaluation and Support to EVD Cured Patients and Their Contacts (Les Vainqueurs d'Ebola)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04409405 |
|
Recruitment Status :
Not yet recruiting
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 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.
| Condition or disease |
|---|
| Ebola Virus Disease |
| Study Type : | Observational |
| Estimated Enrollment : | 2300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation and Support to Ebola Virus Disease Cured Patients and Their Contacts in the Democratic Republic of the Congo |
| Estimated Study Start Date : | June 2020 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | September 2021 |
| Group/Cohort |
|---|
|
Cured population
• Age ≥ 5 year old
|
Contact population
|
- Cured-participant population co-infections [ Time Frame: Baseline (BL) ]Frequencies of co-infections (HIV, HBV, HCV)
- 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 caracteristics 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 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 PBMC cells 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, NK cells, DC, 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.
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409405
| Congo, The Democratic Republic of the | |
| Beni Hospital | |
| Beni, Congo, The Democratic Republic of the | |
| Contact: Eric Delaporte 0033 4 67 41 62 97 eric.delaporte@ird.fr | |
| Principal Investigator: John K Manzombo | |
| Butembo Hospital | |
| Butembo, Congo, The Democratic Republic of the | |
| Contact: Erix Delaporte 0033 4 67 41 62 97 eric.delaporte@ird.fr | |
| Principal Investigator: Skoda M Muyisa | |
| Mambasa Hospital | |
| Mambasa, Congo, The Democratic Republic of the | |
| Contact: Eric Delaporte 0033 4 67 41 62 97 eric.delaporte@ird.fr | |
| Principal Investigator: Béatrice D Osako | |
| Mangina Hospital | |
| Mangina, Congo, The Democratic Republic of the | |
| Contact: Eric Delaporte 0033 4 67 41 62 97 eric.delaporte@ird.fr | |
| Principal Investigator: Serge M Kavalami | |
| Responsible Party: | Institut National de la Santé Et de la Recherche Médicale, France |
| ClinicalTrials.gov Identifier: | NCT04409405 |
| Other Study ID Numbers: |
C19-59 ESP/CE/287/2019 ( Other Identifier: EC Kinshasa School of Public Health ) |
| First Posted: | June 1, 2020 Key Record Dates |
| Last Update Posted: | June 1, 2020 |
| Last Verified: | May 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Ebola Democratic Republic of the Congo DRC Ituri North Kivu |
|
Virus Diseases Hemorrhagic Fever, Ebola Hemorrhagic Fevers, Viral |
RNA Virus Infections Filoviridae Infections Mononegavirales Infections |