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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02342171 |
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Date of registration:
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12/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea
Ebola-Tx |
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Scientific title:
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Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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606 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02342171 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Guinea
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Contacts
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Name:
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Johan van Griensven, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ITM |
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Name:
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Niankoye Haba, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Blood Transfusion Centre (NBTC), Conakry, Guinea |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hemorrhagic Fever, Ebola
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Intervention(s)
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Other: Convalescent Plasma
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Primary Outcome(s)
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Survival at Day 14 After Start of Intervention
[Time Frame: 14 days]
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Secondary Outcome(s)
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Mortality Risk Factor: Age
[Time Frame: 30 days]
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Number of Participants With 30 Days Survival
[Time Frame: 30 days]
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Mortality Risk Factor: Ct
[Time Frame: 30 days]
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Number of Professional Safety Incidents
[Time Frame: 9 months]
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Titer of Ebola Viral RNA
[Time Frame: 30 days]
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Number of Participants Who Died Corresponding to EV Antibody Levels (Anti-EBOV IgG)
[Time Frame: 14 days]
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Number of Participants Who Died Corresponding to EV Antibody Levels (Neutralizing Antibodies)
[Time Frame: 14 days]
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Number of Transfusion-related Serious Adverse Reactions (SARs)
[Time Frame: 30 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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