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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
Sponsor:
Collaborators:
National Blood Transfusion Centre (NBTC), Conakry, Guinea
Gamal Abdel Nasser University of Conakry
National Center for Training and Research of Maferinyah, Guinea
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
University of Oxford
University of Liverpool
London School of Hygiene and Tropical Medicine
Aix Marseille Université
UBIVE, Institut Pasteur, Paris, France
Institut National de la Santé Et de la Recherche Médicale, France
Etablissement Français du Sang
Belgian Red Cross
Institut Pasteur, Dakar, Sénégal
Médecins Sans Frontières, Belgium
World Health Organization
International Severe Acute Respiratory and Emerging Infection Consortium
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

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 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Survival time [ Time Frame: 30 days ]
    Effect of convalescent plasma in improving patients survival at day 30

  2. 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

  3. EV antibody levels [ Time Frame: 14 days ]
    To assess the relationship between EVD antibody levels and survival in patients who received CP

  4. 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

  5. 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

  6. 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.).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Guinea
Ebola Treatment Center
Donka, Guinea
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
National Blood Transfusion Centre (NBTC), Conakry, Guinea
Gamal Abdel Nasser University of Conakry
National Center for Training and Research of Maferinyah, Guinea
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
University of Oxford
University of Liverpool
London School of Hygiene and Tropical Medicine
Aix Marseille Université
UBIVE, Institut Pasteur, Paris, France
Institut National de la Santé Et de la Recherche Médicale, France
Etablissement Français du Sang
Belgian Red Cross
Institut Pasteur, Dakar, Sénégal
Médecins Sans Frontières, Belgium
World Health Organization
International Severe Acute Respiratory and Emerging Infection Consortium
Investigators
Study Chair: Johan van Griensven, MD ITM
Principal Investigator: Niankoye Haba, MD National Blood Transfusion Centre (NBTC), Conakry, Guinea

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT02342171     History of Changes
Other Study ID Numbers: ITM0614
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Keywords provided by Institute of Tropical Medicine, Belgium:
Ebola Viral Disease
Convalescent Plasma
Developing Countries

Additional relevant MeSH terms:
Emergencies
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
Virus Diseases
Disease Attributes
Pathologic Processes
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections