Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea (Ebola-Tx)
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|ClinicalTrials.gov Identifier: NCT02342171|
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : February 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhagic Fever, Ebola||Other: Convalescent Plasma||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Convalescent Plasma
Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg
Other: Convalescent Plasma
Patients will be treated with plasma from recovered EVD patients.
No Intervention: standard care
The control arm will consist of historical controls having being treated with standard of care
- Survival time [ Time Frame: 14 days ]Effect of convalescent plasma in improving patients survival at day 14; it will be considered clinically significant if there is an absolute decrease in the case fatality rate of 20% or more, compared to SC alone
- Survival time [ Time Frame: 30 days ]Effect of convalescent plasma in improving patients survival at day 30
- Titer of Ebola viral RNA [ Time Frame: 30 days ]To assess the relationship between EVD antibody levels and the changes in levels of viral RNA in patients who received CP
- EV antibody levels [ Time Frame: 14 days ]To assess the relationship between EVD antibody levels and survival in patients who received CP
- Number of transfusion-related serious adverse reactions (SARs) [ Time Frame: 30 days ]To assess the occurrence of serious adverse reactions (SARs) related to CP transfusion in Ebola patients
- Number of professional safety incidents [ Time Frame: 9 months ]To assess the occurrence of safety risks related to CP transfusion in health workers administering the treatments. This will be observed throughout the study
- Mortality risk factors [ Time Frame: 30 days ]To determine risk factors for mortality despite administration of CP. Possible factors will be detailed in the Analysis Plan and will include patient demographics (age, sex...), time elapsed between symptoms onset and start of therapy, duration and severity of symptoms (bleeding, vomiting, diarrhea, fever, consciousness level, etc.).
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): NCT02342171
|Ebola Treatment Center|
|Study Chair:||Johan van Griensven, MD||ITM|
|Principal Investigator:||Niankoye Haba, MD||National Blood Transfusion Centre (NBTC), Conakry, Guinea|