Last Verified: | October/10/2019 |
First Submitted: | October/23/2018 |
Estimated Enrollment Submitted: | October/23/2018 |
First Posted: | October/24/2018 |
Last Update Submitted: | October/17/2019 |
Last Update Posted: | October/20/2019 |
Actual Study Start Date: | November/20/2018 |
Estimated Primary Completion Date: | September/8/2019 |
Estimated Study Completion Date: | November/29/2023 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Experimental: A Remdesivir plus optimized Standard of Care (oSOC) | Drug: A Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg remdesivir 2.5 mg/kg) |
Experimental: B MAb114 plus optimized Standard of Care (oSOC) | Drug: B 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion |
Experimental: C REGN-EB3 plus optimized Standard of Care (oSOC) | Drug: C 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion |
Experimental: Control Zmapp plus optimized Standard of Care (oSOC) | Drug: Control Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1 |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | - INCLUSION CRITERIA: - Males or females of any age with documented positive RT-PCR in blood for acute Ebola virus infection within 3 days prior to enrollment and who have symptoms of any duration. - Willingness of study participant to accept randomization to any assigned treatment arm. - All males and females of childbearing potential must be willing to use effective methods of contraception, from time of enrollment until Day 58 of study. - Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study. - Ability to provide informed consent personally, or by a legally acceptable representative if the patient is unable to do so. EXCLUSION CRITIERA: - Patients who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through Day 28. - Prior treatment with any investigational antiviral drug therapy against Ebola virus infection within 5 half-lives or 30 days, whichever is longer, prior to enrollment. (Patients who have received an experimental (or, in future, potentially a licensed) immunization against Ebola virus remain eligible.) |