Clinical Trial: Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea
Brief 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 A
Detailed Summary:
West-Africa is being ravaged by the worst outbreak of Ebola Viral Disease (EVD) ever witnessed. Nine months after its onset, the outbreak has spiraled and currently appears to be out of control. One of the key factors contributing to the high mortality is the lack of any proven effective EVD specific treatment. The identification of effective therapies is a medical and public health priority. Convalescent whole blood (CWB) and convalescent plasma (CP) have been prioritized by the World Health Organization (WHO) to be evaluated within a short time span, so that widespread use for therapy could be implemented rapidly if proven effective. Both CWB and CP contain EBV antibodies and either could potentially be of value as EVD therapy, however their efficacy in Ebola must still be demonstrated. .
This is an emergency, phase 2/3, open-label, non-randomized, clinical trial that will evaluate CP added to standardized supportive care (SC) in patients with confirmed 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. Secondary objectives are;
- to assess 30 day survival on CP + SC
- to assess the relationship between EV antibody levels in donated CP and survival in patients receiving CP
- to assess the relationship betwee
Sponsor: Institute of Tropical Medicine, Belgium
Current Primary Outcome: 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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.).
Original Secondary Outcome:
- 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: 14 days ]To assess the occurrence of serious adverse reactions (SARs) related to CP transfusion in Ebola patients
- Number of professional safety incidents [ Time Frame: whole study ]To assess the occurrence of safety risks related to CP transfusion in health workers administering the treatments
- Mortality risk factors [ Time Frame: whole study ]To determine risk factors for mortality despite administration of CP (for identification of patients most likely to benefit)
Information By: Institute of Tropical Medicine, Belgium
Dates:
Date Received: January 12, 2015
Date Started: February 2015
Date Completion:
Last Updated: February 7, 2017
Last Verified: February 2017
- Survival time [ Time Frame: 30 days ]
