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

JRCT ID: jRCTs031220480

Registered date:29/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ebola virus disease
• Date of first enrollment: 01/12/2022
• Target sample size: 5
• Study type: Interventional

Intervention(s)

Remdesivir will be administered as follows:
First day: Initial dose 150 mg once daily by intravenous infusion
Days 2 to 10: 100 mg once daily by intravenous infusion

Outcome(s)

Primary Outcome

The percentage of the study participants who developed Ebola Virus Disease (EVD) during the study period.

The diagnosis of EVD shall be made by one of the following methods in accordance with the "Law Concerning Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases" in Japan.

Detection of pathogens by separation and identification (blood, throat swab, and urine)
Detection of pathogen antigens by ELISA (blood, throat swab, and urine)
Detection of genes of pathogens by PCR (blood, pharyngeal swab, and urine)
Detection of IgM or IgG antibodies by fluorescent antibody or ELISA (serum) Detection of IgM or IgG antibodies by fluorescent antibody or ELISA (serum)

Secondary Outcome

1) Viral load using various types of samples (blood, pharyngeal swab fluid, and urine) from study participants
2) Detection of cytokines/chemokines, etc. in serum (monitoring by SIRS, etc.)
3) Measurement of D-dimer, aPTT, PT, activated-Protein C, etc. (monitoring of DIC)
4) Adverse events of Remdesivir

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

(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.

Related Information

• Primary Sponsor: Shinichiro Morioka
• Secondary Sponsor: Norio Ohmagari,Japan Agency for Medical Research and Development (AMED)