Acute Ebola Virus Disease Clinical Trial
Official title:
A Prospective, Open Label Observational, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus Disease
| Verified date | March 2021 |
| Source | Cerus Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this Phase 1 safety study is to provide access to the potential therapeutic benefit of EBOV convalescent plasma containing antibodies to EBOV. The risk of exposure to plasma from donors who may be infected with other transfusion-transmitted pathogens, not detectable by current licensed donor testing procedures, will be mitigated by using pathogen inactivation to minimize the risk of the TTI from these donors, who would otherwise be deferred and ineligible for blood donation.
| Status | Terminated |
| Enrollment | 6 |
| Est. completion date | December 2020 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: EBOV Convalescent Donor Inclusion Criteria: - Recovered from Ebola Virus Disease (EVD) by clinical criteria and declared clinically asymptomatic of active EVD. - Twenty-eight (28) days from hospital discharge. - Two negative test results for EBOV nucleic acid by a sensitive nucleic acid test method with blood samples drawn at least 48 hours apart. - Plasma/serum tested for HIV, HTLV, HCV, HBV, syphilis, and other pathogens (per institutional practice) using licensed test methods. Inclusion of donors with positive test results for these pathogens will be at the discretion of treating physicians, with respect to the relative benefit of donor subject convalescent plasma treated with INTERCEPT pathogen inactivation, compared to the risk to recipients of not receiving EBOV convalescent plasma transfusion therapy. - ABO blood group and RhD typing performed and donor anti-A and anti-B titers performed. - Plasma/serum tested for human leukocyte antigen (HLA) antibodies for female donors with history of pregnancy and for donors with a history of transfusions (per institutional practice) using licensed test methods for transfusion-related acute lung injury (TRALI) risk mitigation. Inclusion of donors with positive test results will be at the discretion of treating physicians, with respect to the relative benefit of donor subject convalescent plasma compared to the risk to recipients of not receiving EBOV convalescent plasma transfusion therapy. - Measurement of antibodies to EBOV, when feasible and ultimately measurement of neutralizing antibodies to EBOV, when available. - Conformity to age and weight standards for blood donors for plasma donation. Variance from standards may be acceptable with evaluation by treating physician(s) and with donor or legal guardian consent for non-conforming donors when collection of reduced volumes of plasma may be of therapeutic value. - Cleared by treating physician for apheresis plasma donation. - Written signed informed consent to donate 650-1300 mL plasma by apheresis at frequencies of twice per week, at the discretion of the treating physician. Recipient Subject Inclusion Criteria: - Acute EVD diagnosed by nucleic acid testing and meeting established case definitions (World Health Organization 2014). - Subject or legal guardian provides written informed consent to receive INTERCEPT plasma. Exclusion Criteria: EBOV Convalescent Donor Exclusion Criteria: • Active EVD Recipient Subject Exclusion Criteria: • Documented food allergy to psoralens |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University | Atlanta | Georgia |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| Lead Sponsor | Collaborator |
|---|---|
| Cerus Corporation |
United States,
Dean CL, Hooper JW, Dye JM, Zak SE, Koepsell SA, Corash L, Benjamin RJ, Kwilas S, Bonds S, Winkler AM, Kraft CS. Characterization of Ebola convalescent plasma donor immune response and psoralen treated plasma in the United States. Transfusion. 2020 May;60 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects who survive EVD | through hospital discharge up to 1 year | ||
| Primary | Proportion of subjects with adverse events | Up to 24 hours post transfusion | ||
| Primary | Proportion of subjects with Serious Adverse Events | Up to 7 days post-transfusion | ||
| Secondary | Time from diagnosis of acute EVD to death due to acute EVD | censored at hospital discharge up to 1 year | ||
| Secondary | Proportion of subjects with clinical remission, where clinical remission is defined as absence of clinical symptoms indicative of EVD and at least two negative EBOV nucleic acid tests at least 48 hours apart prior to hospital discharge. | through hospital discharge up to 1 year | ||
| Secondary | Time from diagnosis of acute EVD to clinical remission. | through hospital discharge up to 1 year | ||
| Secondary | Reduction of EBOV viral load titers by nucleic acid testing prior to hospital discharge. | through hospital discharge up to 1 year | ||
| Secondary | Subject hemostatic function pre INTERCEPT plasma and post last INTERCEPT plasma transfusion (prior to discharge), as available: o Prothrombin time o International Normalized Ratio (INR) o Activated partial thromboplastin time o Fibrinogen activity | pre and post transfusion up to 1 year |