Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT04409405
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT04409405
Study Brief:
Protocol Section:
NCT04409405