Interferon-ß treatment for Ebola virus disease
- Conditions
- Acute ebola virus diseaseInfections and Infestations
- Registration Number
- ISRCTN17414946
- Lead Sponsor
- Sustainable health Foundation (FOSAD) & Center of Excellence for Training on Research and Priority Diseases (CEFORPAG)
- Brief Summary
2017 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5321269/ (added 01/03/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1. Able to provide informed consent (ubstitute decision maker may provide informed consent in cases where the patient is ill and unable to provide informed consent)
2. Aged between 18 and 70 years on the day of inclusion
3. In the treatment centre
4. Confirmed ebola virus infection by RT-PCR
5. Symptom onset < 6 days
6. Able to comply with trial procedures
1. Known hypersensitivity to IFN ß preparations
2. Pregnancy
3. Chronic liver disease with synthetic dysfunction and/or decompensation, history of bleeding
4. Moderate to severe congestive heart failure - grade III or IV left ventricular function
5. Previous history of serious psychiatric illness
6. History of sever or active autoimmune disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Viral load reduction/clearance from the blood is determine using a semi-quantitative RT-PCR assay at baseline, 2, 4 , 6, 9, 11, 13 and 15 days.
- Secondary Outcome Measures
Name Time Method <br> 1. Safety of IFN ß-1a treatment is determined by monitoring for any adverse events daily for the time period each patient is in the treatment unit<br> 2. Occurrence, nature and severity of adverse events events are determined by the clinical team and attending MD at the Coyah Treatment Unit daily for the time period each patient is in the treatment unit<br>