Evaluation of a post-exposure prophylaxis using Remdesivir against Ebola virus disease, a single-arm interventional trial - RemEP

Shinichiro Morioka0 个研究点目标入组 5 人开始时间: 2022年11月29日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Have given written consent to participate in the study
•2) 18 years of age or older at the time consent is given
•3) Meet any of the following selection criteria 3-1) to 3-4)
•3-1) Have touched a sample (including body fluids) contaminated with Ebola virus (EV) on the mucous membranes of the eyes, nose, mouth, etc. (infection risk: high)
•3-2) Have a skin injury from an instrument contaminated with EV (infection risk: high)
•3-3) Have possibly touched a sample (including body fluids) contaminated with EV directly on their uninjured skin (infection risk: moderate)
•3-4) Have a risk of infection similar to 3-1 to 3-3 above, and the benefit of post-exposure prophylaxis is judged to outweigh the risk of medication by the principal investigator or a sub-investigator
•4) Within 21 days of last exposure to EV

•(1) Have a severe allergy to Remdesivir
•(2) Judged illegible to participate in the study by the principal investigator or sub-investigator (Note 1)
•(Note 1) Use of Remdesivir for pregnant and lactating women:
•Since no apparent adverse events in pregnant women or fetuses have been reported in a few observational studies of COVID-19, the use of Remdesivir in pregnant women is considered well tolerated. In addition, using Remdesivir in lactating women is considered acceptable because neonates are unlikely to absorb clinically significant amounts of Remdesivir from breast milk, and no serious adverse events in infants have been reported in a small number of studies of Ebola Virus Disease or COVID-19. Therefore, its use is considered acceptable. When administering the drug, the principal investigator or a sub-investigator will consult with the study participant to determine whether the participant is eligible to participate.

发起方

Shinichiro Morioka