Ebola Virus Disease Clinical Trial
— EVD001Official title:
A Phase I/II Pilot Clinical Trial to Evaluate the Efficacy and Safety of Ebola Virus Disease (EVD) Convalescent Plasma (ECP) for Treatment of EVD
A Phase I/II Pilot Clinical Trial to Evaluate the Efficacy and Safety of Ebola Virus Disease (EVD) Convalescent Plasma (ECP) for treatment of EVD.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | June 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult male or female 18 years of age or older - Confirmed case of EVD (CDC case definitions 14 SEP 2014) - Admission to the hospital no more than 48 hours prior to availability of investigational product - Able and willing to provide informed consent or family member who is willing and able to provide informed consent if potential subject is unable to consent - Venous access adequate for administration of plasma - Females only: negative qualitative urine Beta-HCG test Exclusion Criteria: - Prior history of severe transfusion reaction - Fluid overload or other condition that would contraindicate administration of plasma at the protocol- specified doses - History of blood product transfusion within 30 days prior to enrollment - Prior treatment with any other specific experimental anti-EVD product or expectation to receive another experimental anti-EVD product during the course of the study (does not include general supportive care or nutritional supplements routinely administered to all hospitalized patients with EVD) - Unresponsive on AVPU (Alert, Voice Responsive, Pain Responsive, Unresponsive) testing |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Liberia | ELWA-2 Ebola Treatment Unit | Monrovia |
Lead Sponsor | Collaborator |
---|---|
Clinical Research Management, Inc. |
Liberia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EBOV viral load in blood of ECP Group as measured by quantitative FDA-authorized DoD EZ1 Real-time RT-PCR using USAMRIID research protocol | 12 Weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00374309 -
Experimental Vaccine for Prevention of Ebola Virus Infection
|
Phase 1 | |
Completed |
NCT03098862 -
PREVAIL VI: Identification of Host Genetic Factors Underlying Ebola Virus Disease Risk, Mortality, Long-term Sequelae, Viral RNA Persistence, Humoral Immunity, and Ebola Vaccine Response
|
||
Completed |
NCT02509494 -
Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
|
Phase 3 | |
Recruiting |
NCT06093646 -
Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda
|
N/A | |
Completed |
NCT02495246 -
A Study to Assess Ebola Vaccines ChAd3-EBO-Z and Ad26.ZEBOV
|
Phase 1 | |
Completed |
NCT04906629 -
INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees
|
Phase 1 | |
Completed |
NCT05064956 -
Ad26.ZEBOV Booster in HIV+ Adults Previously Vaccinated With Ad26.ZEBOV/MVA-BN-Filo (EBOVAC HIV+ Booster Study)
|
Phase 2 | |
Not yet recruiting |
NCT06126822 -
Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination With the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC
|
Phase 3 | |
Completed |
NCT02267109 -
Phase 1 Trial of Ebola Vaccine in Mali
|
Phase 1 | |
Withdrawn |
NCT04268966 -
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
|
Phase 2 | |
Not yet recruiting |
NCT04822376 -
Prophylaxis Vaccine Antibodies Ebola
|
Phase 2 | |
Completed |
NCT02662855 -
Efficacy of Favipiravir Against Severe Ebola Virus Disease
|
Phase 2 | |
Active, not recruiting |
NCT04152486 -
Effectiveness and Safety of a Heterologous, Two-dose Ebola Vaccine in the DRC
|
Phase 3 | |
Terminated |
NCT04250168 -
Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response
|
||
Completed |
NCT03161366 -
Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine
|
Phase 3 | |
Completed |
NCT03140774 -
Persistence of the Immune Response After Immunisation With Ebola Virus Vaccines
|
||
Suspended |
NCT03462004 -
Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein
|
Phase 1 | |
Active, not recruiting |
NCT02876328 -
Partnership for Research on Ebola VACcinations
|
Phase 2 | |
Not yet recruiting |
NCT05202288 -
Pilot Study Evaluating the Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers
|
Phase 2 | |
Completed |
NCT02401373 -
A Phase I Trial to Evaluate Ad5-EBOV in Healthy Adult Africans in China.
|
Phase 1 |