A Multicenter Randomized Safety and Efficacy Study of Putative Investigational Therapeutics in the Treatment of Patients with Known Ebola Infection

ational Institute of Allergy and Infectious Diseases0 个研究点目标入组 1,000 人开始时间: 2015年3月10日最近更新: 2023年5月29日

试验速览

暂无简介。

•Males or females with documented positive PCR for Ebola virus infection within 10 days of enrollment
•-Willingness of study participant to accept randomization to any assigned treatment arm
•-Access to oSOC
•-All males and females of childbearing potential, must be willing to use highly effective [e.g. absolute abstinence from potentially reproductive sexual activity, hormonal, surgical or multiple barrier/combined] methods of contraception, from time of enrollment through at least 90 days after viral clearance
•-Must agree not to enroll in another study of an investigational agent prior to completion of last required protocol visit
•-Ability to provide informed consent personally, or by a legally-authorized [per applicable local laws and regulations] representative [LAR] if the patient is unable to do so.

•-Any medical condition that, in the opinion of the site investigator, would place the patient at an unreasonably increased risk through participation in this study, including any past or concurrent conditions that would preclude randomization to one or more of the assigned treatment arms (e.g., severe nausea and vomiting precluding use of oral therapies).
•-Prior treatment with any investigational antiviral drug therapy against Ebola infection or investigational anti-Ebola vaccine within 5 half lives or 30 days, whichever is longer, prior to enrollment.
•-Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol

发起方

ational Institute of Allergy and Infectious Diseases