Phase 3
N=606
Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea
Hemorrhagic Fever, Ebola
Bottom Line
View on ClinicalTrials.gov: NCT02342171 ↗Enrolled (actual)
606
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Survival at Day 14 After Start of Intervention — 58; 260 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Convalescent Plasma (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Institute of Tropical Medicine, Belgium
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival at Day 14 After Start of Intervention |
58; 260 | — |
| SECONDARY Number of Participants With 30 Days Survival |
57 | — |
| SECONDARY Titer of Ebola Viral RNA |
1; 0.30; -0.46 | — |
| SECONDARY Titer of Ebola Viral RNA |
1; 0.30; -0.46 | — |
| SECONDARY Number of Participants Who Died Corresponding to EV Antibody Levels (Anti-EBOV IgG) |
5; 11; 8 | — |
| SECONDARY Number of Participants Who Died Corresponding to EV Antibody Levels (Neutralizing Antibodies) |
6; 8; 10 | — |
| SECONDARY Number of Transfusion-related Serious Adverse Reactions (SARs) |
— | — |
| SECONDARY Number of Professional Safety Incidents |
— | — |
| SECONDARY Mortality Risk Factor: Ct |
11; 90; 11; 56; 4; 12 | — |
| SECONDARY Mortality Risk Factor: Age |
1; 15; 1; 10; 16; 90 | — |
Summary
This is an emergency, phase 2/3, open-label, non-randomized, clinical trial that will evaluate Convalescent Plasma (CP) added to standardized supportive care (SC) in patients with confirmed Ebola Virus Disease (EVD). No patient will be refused CP when compatible products are available and all efforts will be made to maximize CP availability during the study. EVD patients recruited during the period before CP becomes available or for whom no compatible CP is available will be given SC and will be followed for study outcomes. Data from these SC patients will be the used as comparator in the analysis of the study. The primary objective of the study is to assess if CP + SC improves the 14 day survival of patients, compared to SC alone.
The Investigators aim to enroll a total number of 130 - 200 patients who will be treated treated with CP assuming equal numbers of patients treated with SC alone. If there would be insufficient patients treated with SC, patients treated at the research site prior to study start may be included in the comparison group.
Patients will be recruited in the Ebola Treatment centre managed by Medecins Sans Frontieres (MSF) in Conakry, Guinea. All patients and/or relatives presenting at the centre will be informed about the study, and will be invited to provide consent at the time of admission inside the treatment centre. Only patients for whom ebola infection is confirmed with polymerase chain reaction (PCR) will be enrolled in the study. After inclusion, eligibility to the intervention will be reassessed on regular intervals. If the eligibility criteria are not met by 48 hours after inclusion, only SC will be continued.
In line with the guidance of the World Health Organization (WHO), two units of CP will be given. EVD patients will be transfused with ABO-compatible CP using standard procedures. Details on the modalities of transfusion can be found in the WHO guidance document and the MSF guidelines on blood transfusion. All patients will be under close observation for transfusion-related adverse reactions during and up to 4 hours after transfusion. 24 hours after the start of transfusion, a blood sample will be collected for viral load assessment. All other aspects of patient management will be according to MSF clinical guidelines. The decision to discharge a patient should be taken on clinical grounds, but can be supported by the laboratory results. After discharge, the patient will be followed up by the study team until day 30.
Eligibility Criteria
Inclusion Criteria
- PCR-confirmed, symptomatic infection with Ebola virus
- Patient's, guardian's or representatives' willingness to provide written informed consent
Exclusion Criteria
A patient is not eligible to receive CP if they meet one of the following criteria:
- History of allergic reaction to blood or plasma products (as judged by the investigator or treating physician);
- Medical conditions in which receipt of additional fluid related to the transfusion (250-500 ml or in the case of children 10 ml/kg) may be detrimental to the patient (e.g. decompensated congestive heart failure or renal failure).
- Patients in shock unresponsive to fluid challenge
- Patients in shock with signs of multi-organ failure, defined as oliguria/anuria AND impaired consciousness AND/OR jaundice
- Condition of patient where the procedure of plasma administration carries a risk for the staff
Data sourced from ClinicalTrials.gov (NCT02342171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.