Investigational Therapeutics for the Treatment of People With Ebola Virus Disease
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|ClinicalTrials.gov Identifier: NCT03719586|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : December 17, 2018
Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give. They need to test the drugs and compare them in a controlled way. Researchers want to test 3 drugs with people who have Ebola and are in treatment centers.
To study the safety and effectiveness of 3 drugs for people with Ebola virus.
People of any age with Ebola infection who are in treatment centers
Participants will be screened with questions, medical history, and blood tests.
Participants will be randomly assigned to get 1 of 3 study drugs:
- ZMapp by IV over about 4 hours. It will be given 3 times, 3 days apart.
- Remdesivir by IV over about 1 hour. It will be given once a day for 10 days.
- Mab114 by IV for 30-60 minutes. It will be given 1 time.
For at least a week, participants will stay in isolation in a clinic. They will:
- Get supportive care and be monitored
- Have a small plastic tube (IV) put in an arm vein for several days to give fluids and collect blood.
- Get their study drug.
- Be monitored for disease signs and drug side effects. They may get medicines for side effects.
- Have blood and urine tests.
Participants will stay in the clinic until they finish the study drug and are well enough to leave.
Participants will have 2 follow-up visits over 2 months. They will answer questions and give blood and semen samples.
|Condition or disease||Intervention/treatment||Phase|
|Ebola Virus||Drug: ZMapp Drug: Remdesivir Drug: MAb114||Phase 2|
Species Zaire ebolaviruses (EBOV) are members of the Filoviridae and are known primarily as the underlying cause of severe viral hemorrhagic fevers with disturbingly high case fatality rates. Between 1994 and the present, there have been many filovirus outbreaks affecting mostly central Africa, with 2 large outbreaks in 1995 in Kikwit, Democratic Republic of Congo (DRC), and in Gulu, Uganda in 2000-2001. The 2013-2016 West African outbreak significantly exceeded all previous outbreaks in geographic range, number of patients affected, and in disruption of typical activities of civil society. In 2018 there have been two additional outbreaks of EBOV infection, both in the Democratic Republic of the Congo and constituting the 9th and 10th recorded outbreaks of this infection in that country. The 10th outbreak is currently ongoing in the DRC as of September 2018 and has raised great concern because of the potential to expand greatly in scope and to spread to surrounding regions.
It has been suggested that one of the most important elements necessary to improve survival from Ebola virus infection is the provision of supportive care inclusive of hemodynamic support in the form of aggressive fluid replacement, ability to diagnose and correct severe metabolic derangements, early treatment of sepsis, and other standards of modern medical care. A small number of investigational therapeutics have been developed as putative antiviral strategies for treating this infection. Unfortunately, phase 1/2 data supporting the safety and efficacy of these agents are often scant, and thus there remains some degree of equipoise as to which of these interventions should be prioritized in the treatment of severe infection. The triple monoclonal antibody product ZMapp was studied through a randomized controlled trial (RCT) in the 2014-2016 West African outbreak and remains perhaps the best characterized of the available investigational products, but the end of that outbreak forced the RCT to close prior to crossing pre-specified evidentiary boundaries.
A WHO Research and Development Ebola Therapeutics Committee agreed that, given the lethality of Ebola virus and the combination of human and non-human primate (NHP) efficacy data for ZMapp, there should be two options for the control arm: either ZMapp+oSOC or oSOC alone. The decision about the appropriate control arm will be at the discretion of the host country. The DRC has chosen to use ZMapp + oSOC.
This multicenter, multi-outbreak, randomized controlled trial will study the comparative safety and efficacy of two additional investigational therapeutics compared to ZMapp in patients with known EBOV disease. The primary endpoint of this trial will be mortality by Day 28, with a number of secondary endpoints that will generate knowledge about the safety, ease of administration, and antiviral activity of these adjunctive interventions.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients With Ebola Virus Disease|
|Estimated Study Start Date :||December 20, 2018|
|Estimated Primary Completion Date :||November 30, 2023|
|Estimated Study Completion Date :||November 30, 2024|
Zmapp plus optimized Standard of Care (oSOC)
Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1.
Remdesivir plus optimized Standard of Care (oSOC)
Loading Dose on Day 1 followed by 9 days of maintenance dosing on Days 2 to 10,administered intravenously.
MAb114 plus optimized Standard of Care (oSOC)
50 mg/kg of body weight administered intravenously on Day 1 as a single infusion.
- Mortality [ Time Frame: Through 28 days ]
- Time to first negative Ebola virus RT-PCR [ Time Frame: Throughout ]
- Viremia [ Time Frame: Days 1, 2, 3, 4, 6, 8, 10, 14, and 28. ]
- Incidence of AE/SAEs [ Time Frame: Throughout ]
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): NCT03719586
|Contact: Richard T Davey, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Congo, The Democratic Republic of the|
|Ebola Treatment Centers throughout the DRC||Recruiting|
|Kinshasa Gombe, Congo, The Democratic Republic of the|
|Contact: Jean-Jacques Muyembe-Tamfum, MD, PhD 243898949289 email@example.com|
|Principal Investigator:||Richard T Davey, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|