Plain English Summary
Background and study aims
Ebola virus disease is a serious illness caused by the Ebola virus. The virus originated in Africa and is particularly common in West Africa, where there is currently a serious outbreak. A person infected with Ebola will usually develop a fever, headache and muscle pain/weakness, but if left untreated, it could lead to serious gastrointestinal (gut) symptoms, impaired kidney and live function, internal bleeding and even death. To date, there are no approved drugs for the treatment of Ebola virus disease. Interferon-β (interferon-beta) is a broad spectrum (general) antiviral medication that has shown limited activity against the Ebola virus in laboratory experiments on cells and animals. Given the severity of the Ebola outbreak in West Africa, a study has been designed to test Interferon-β on people with Ebola virus disease in Guinea (West Africa). The aim of this study is to evaluate the safety and effectiveness of Interferon-β in the treatment of patients with Ebola virus disease.
Who can participate?
Adults with Ebola virus disease, who are being treated in the Coyah Ebola Treatment Unit (Guinea).
What does the study involve?
After agreeing to take part, participants receive an injection of Interferon-β under the skin every day for up to 10 days. During this time, patients also receive standard treatment including receiving fluids, pain and fever medication, vitamins, anti-sickness tablets and antibiotics. Participants have a sample of blood taken at the start of the study and then after 2, 4, 6, 9, 11, 13 and 15 days to test the level of the virus present in the body. Participants are also monitored in order to record any negative side effects they get from the medication.
What are the possible benefits and risks of participating?
There is a chance than participants may benefit from a better recovery form Ebola virus disease because of the Interferon-β treatment. The risks associated with this treatment are not known in the treatment of Ebola virus disease but patients will be closely monitored for side effects. There is also a risk of pain or bruising from the blood testing.
Where is the study run from?
Coyah Ebola Treatment Unit (Guinea)
When is the study starting and how long is it expected to run for?
March 2015 to December 2016
Who is funding the study?
Canadian Institutes of Health Research (Canada)
Who is the main contact?
Dr Eleanor Fish
en.fish@utoronto.ca
Study website
Contact information
Type
Scientific
Contact name
Dr Eleanor Fish
ORCID ID
Contact details
Toronto General Research Institute
67 College Street
Toronto
M5G 2M1
Canada
+1 416 340 5380
en.fish@utoronto.ca
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
2014-EBOV
Study information
Scientific title
A pilot study to evaluate the safety and efficacy of interferon beta-1a (IFN β-1a) in the treatment of patients presenting with Ebola virus illness
Acronym
Study hypothesis
IFN β-1a treatment is an effective treatment for Ebola virus disease.
Ethics approval(s)
Guinean Comite National D'Ethique pour la Recherche en Sante (CNERS), ref: 016/CNERS/15
Study design
Single-centre single-arm phase I/II non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute ebola virus disease
Intervention
All participants receive subcutaneous injection of 30µg (6 x 10v6 IU) IFN β-1a daily for up to 10 days, until two consecutive PCR CT values for ebola viremia in blood were >40 (ie virus undetectable), 48 hours apart. Patients that are PCR negative for blood viremia are discharged from the Coyah Treatment Unit after the second negative PCR value, having resolved all clinical symptoms of Ebola virus disease.
Patients also recieve standardized supportive care throughout, including rehydration solution, pain and fever medication (Novalgin, Paracetamol), Plumpy'Nut therapeutic diet, vitamin B complex, multivitamins, oral Omerprazole or intravenous Metoclopramide, cephalosporin antibiotics Cefixme (oral) and Ceftriaxone (intravenous), antibiotic Metronidazole, and the anti-malarial, Coartem.
Participants are followed up at 2, 4 , 6, 9, 11, 13 and 15 days.
Intervention type
Biological/Vaccine
Pharmaceutical study type(s)
Phase
Phase I/II
Drug/device/biological/vaccine name(s)
Primary outcome measure
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
1. Safety of IFN β-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
Overall study start date
22/09/2014
Overall study end date
19/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
30-50
Participant exclusion criteria
1. Known hypersensitivity to IFN β 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
Recruitment start date
26/03/2015
Recruitment end date
12/06/2015
Locations
Countries of recruitment
Guinea
Study participating centre
Coyah Ebola Treatment Unit
Coyah
-
Guinea
Funders
Funder type
Government
Funder name
Canadian Institutes of Health Research
Alternative name(s)
Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Results and Publications
Publication and dissemination plan
Planned publication of data acquired in a peer-reviewed scientific journal.
Intention to publish date
01/07/2016
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/02/2017 | 01/03/2019 | Yes | No |