Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea

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.

Conditions

• Hemorrhagic Fever, Ebola

Interventions

OTHER

Convalescent Plasma

Patients will be treated with plasma from recovered EVD patients.

Sponsors & Collaborators

• National Blood Transfusion Centre (NBTC), Conakry, Guinea

  collaborator UNKNOWN

• Gamal Abdel Nasser University of Conakry

  collaborator OTHER

• National Center for Training and Research of Maferinyah, Guinea

  collaborator UNKNOWN

• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Aix Marseille Université

  collaborator OTHER

• UBIVE, Institut Pasteur, Paris, France

  collaborator UNKNOWN

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Etablissement Français du Sang

  collaborator OTHER

• Belgian Red Cross

  collaborator OTHER

• Institut Pasteur, Dakar, Sénégal

  collaborator UNKNOWN

• Médecins Sans Frontières, Belgium

  collaborator OTHER

• World Health Organization

  collaborator OTHER

• International Severe Acute Respiratory and Emerging Infection Consortium

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  lead OTHER

Principal Investigators

• Johan van Griensven, MD · ITM

• Niankoye Haba, MD · National Blood Transfusion Centre (NBTC), Conakry, Guinea

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2015-07-31

Completion

2015-07-31

Countries

• Guinea

Study Locations