Condition category
Infections and Infestations
Date applied
14/07/2016
Date assigned
19/07/2016
Last edited
20/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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-ß 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 ß on people with Ebola virus disease in Guinea (West Africa). The aim of this study is to evaluate the safety and effectiveness of Interferon-ß 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-ß 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-ß 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

Trial website

Contact information

Type

Scientific

Primary contact

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 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 ß-1a) in the treatment of patients presenting with Ebola virus illness

Acronym

Study hypothesis

IFN ß-1a treatment is an effective treatment for Ebola virus disease.

Ethics approval

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

Trial setting

Other

Trial 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 ß-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

Phase

Drug names

Primary outcome measures

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 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

Overall trial start date

22/09/2014

Overall trial end date

19/04/2016

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

30-50

Participant 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

Recruitment start date

26/03/2015

Recruitment end date

12/06/2015

Locations

Countries of recruitment

Guinea

Trial participating centre

Coyah Ebola Treatment Unit
Coyah
-
Guinea

Sponsor information

Organisation

Sustainable health Foundation (FOSAD) & Center of Excellence for Training on Research and Priority Diseases (CEFORPAG)

Sponsor details

Nongo Commune Ratoma
Conakry
-
Guinea

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes