Acute ebola virus disease Infections and Infestations Acute ebola virus disease
Conditions
Interventions
All participants receive subcutaneous injection of 30µg (6 x 10v6 IU) IFN ß-1a daily for up to 10 days, until two consecutive PCR CT values for ebola viremia in blood were >40 (ie virus undetectable),
Sponsors
Sustainable health Foundation (FOSAD) & Center of Excellence for Training on Research and Priority Diseases (CEFORPAG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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 | — |
Countries
Guinea
Outcome results
None listed