Prevention of the onset of Ebola virus and Ebola hemorrhagic fever in persons exposed to Ebola patie Ebora Virus
Conditions
Interventions
First day of treatment Initial dose 150 mg once daily by intravenous infusion
Dose Days 2 to 10 100 mg once daily by intravenous infusion
Sponsors
Morioka Shinichiro
Ohmagari Norio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. those who have given written consent to participate in the research 2. be at least 18 years of age at the time of enrollment 3. who have suffered skin injuries due to sharp instruments contaminated (or potentially contaminated) with Ebola viruses 4. a person whose mucous membranes or skin with a wound has been contaminated by a sample or specimen that is (or may be) contaminated with a Ebola virus 5. a person who has been in contact with a confirmed (or suspected) patient with Ebola virus for more than 1 hour in an enclosed space without wearing appropriate infection protective equipment 6. a person who performed emergency procedures such as cardiopulmonary resuscitation on a confirmed (or suspected) patient with Ebola virus without wearing appropriate infection protective equipment 7. Persons for whom post-exposure prophylaxis is deemed desirable by the Principal Investigator(s) as a situation equivalent to 3 to 6 above.
Exclusion criteria
Exclusion criteria: 1. persons with known severe allergy to Remdecivir 2. Persons who already have Ebola 3. Persons deemed by the principal investigator or subinvestigator to be ineligible to participate in this study 4. Those who have been exposed for more than 22 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral hemorrhagic fever at the end of the study or at the time of discontinuation, and the percentage of participants in the study who developed Ebola during the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. positive PCR test (blood) by the end of the study or at the time of discontinuation 2. positive viral antibody test by the end of the study or at the time of discontinuation 3. death at the end of the study or at the time of discontinuation 4. change over time of the following symptoms specific to viral hemorrhagic fever High fever (39 to 41 degrees C), general malaise, major arthralgia, sore throat, cough, myalgia, epigastric pain, retrosternal pain, vomiting, nausea, diarrhea, abdominal pain, edema of the face and neck, hemorrhage of the conjunctiva of the eye | — |
Contacts
Public ContactSho Saito
Japan Institute for Health Security(JIHS)
Outcome results
None listed