Hemorrhagic Fever, Ebola Clinical Trial
— Ebola-TxOfficial title:
Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea
Verified date | July 2019 |
Source | Institute of Tropical Medicine, Belgium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 606 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Guinea | Ebola Treatment Center | Donka |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium | Aix Marseille Université, Belgian Red Cross, Etablissement Français du Sang, Gamal Abdel Nasser University of Conakry, Institut National de la Santé Et de la Recherche Médicale, France, Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, Institut Pasteur, Dakar, Sénégal, International Severe Acute Respiratory and Emerging Infection Consortium, London School of Hygiene and Tropical Medicine, Médecins Sans Frontières, Belgium, National Blood Transfusion Centre (NBTC), Conakry, Guinea, National Center for Training and Research of Maferinyah, Guinea, UBIVE, Institut Pasteur, Paris, France, University of Liverpool, University of Oxford, World Health Organization |
Guinea,
van Griensven J, Edwards T, Baize S; Ebola-Tx Consortium. Efficacy of Convalescent Plasma in Relation to Dose of Ebola Virus Antibodies. N Engl J Med. 2016 Dec 8;375(23):2307-2309. doi: 10.1056/NEJMc1609116. Epub 2016 Nov 14. — View Citation
van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival at Day 14 After Start of Intervention | 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 | 14 days | |
Secondary | Number of Participants With 30 Days Survival | Effect of convalescent plasma in improving patients survival at day 30 | 30 days | |
Secondary | Titer of Ebola Viral RNA | To assess the relationship between EVD antibody levels (EBOV IgG) in donated plasma and the changes in levels of viral RNA in patients who received Convalescent Plasma. The outcome shows the overall association between antibody dose category and change in Cycle threshold (Ct) value pre and post transfusion (Ct is the number of cycles that have to be run before reaching a threshold value of a positive result). |
30 days | |
Secondary | Titer of Ebola Viral RNA | To assess the relationship between EVD antibody levels (neutralizing antibodies) in donated plasma and the changes in levels of viral RNA in patients who received Convalescent Plasma. The outcome shows the overall association between antibody dose category and change in Cycle threshold (Ct) value pre and post transfusion (Ct is the number of cycles that have to be run before reaching a threshold value of a positive result). |
30 days | |
Secondary | Number of Participants Who Died Corresponding to EV Antibody Levels (Anti-EBOV IgG) | To assess the relationship between EVD antibody levels (anti-EBOV IgG) and death in patients who received Convalescent Plasma | 14 days | |
Secondary | Number of Participants Who Died Corresponding to EV Antibody Levels (Neutralizing Antibodies) | To assess the relationship between EVD antibody levels (neutralizing antibodies) and death in patients who received CP | 14 days | |
Secondary | Number of Transfusion-related Serious Adverse Reactions (SARs) | To assess the occurrence of serious adverse reactions (SARs) related to CP transfusion in Ebola patients | 30 days | |
Secondary | Number of Professional Safety Incidents | To assess the occurrence of safety risks related to CP transfusion in health workers administering the treatments. This will be observed throughout the study | 9 months | |
Secondary | Mortality Risk Factor: Ct | To determine Ct as risk factor for mortality despite administration of CP. | 30 days | |
Secondary | Mortality Risk Factor: Age | To determine age as risk factor for mortality despite administration of CP. | 30 days |
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