Interferon-ß treatment for Ebola virus disease

• Register: ISRCTN
• Last refreshed on: 25 March 2019
• Main ID: ISRCTN17414946
• Date of registration: 19/07/2016
• Prospective Registration: No
• Primary sponsor: Sustainable health Foundation (FOSAD) & Center of Excellence for Training on Research and Priority Diseases (CEFORPAG)
• Public title: Interferon-ß treatment for Ebola virus disease
• 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
• Date of first enrolment: 26/03/2015
• Target sample size: 50
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN17414946
• Study type: Interventional
• Study design: Single-centre single-arm phase I/II non-randomised study (Treatment)
• Phase: Phase I/II

Countries of recruitment

Guinea

Contacts

• Name: Eleanor Fish

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Acute ebola virus disease
Infections and Infestations
Acute ebola virus disease

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

2014-EBOV

Source(s) of Monetary Support

Canadian Institutes of Health Research

Ethics review

Status:
Approval date:
Contact:

Guinean Comite National D'Ethique pour la Recherche en Sante (CNERS), ref: 016/CNERS/15

Results

• Results available: Yes
• Date Completed: 19/04/2016