Convalescent plasma for early Ebola virus disease in Sierra Leone
| ISRCTN | ISRCTN13990511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13990511 |
| Secondary identifying numbers | Protocol number: MOHS-CST001; Pan African Clinical Trials Registry number: PACTR201602001355272 |
- Submission date
- 20/04/2015
- Registration date
- 27/04/2015
- Last edited
- 17/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Ebola virus disease is a severe, often fatal illness which is caught by direct contact with an infected persons blood, secretions, organs or other bodily fluids and from materials (such as bedding) contaminated with these fluids. Early symptoms of infection include flu-like symptoms and fever, headache and intense muscle weakness. Stomach pain, vomiting, diarrhoea then follows and liver and kidney function is also affected. Finally, there is internal bleeding, with blood often seen to bleed from the ears, eyes, nose and mouth. The infection is fatal in between 50-90% of cases. There is not, as present, any licensed treatment or vaccine for Ebola virus disease. However, there are a range of potential treatments including blood products, immune therapies and drug therapies being tested. Here, we want to rapidly assess how well convalescent plasma (CP), that is plasma from survivors of the Ebola virus, works as a treatment for the condition and safe it is to give to patients.
Who can participate?
People of any age admitted to a Ebola treatment unit and diagnosed with the virus and also health care workers who have been placed at risk of being infected. Survivors of Ebola virus are invited to donate their plasma for treatment.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention) are given a single transfusion of CP. Those in group 2 (control) are given the same amount of Ringer’s Lactate solution. Patients in both groups are also given the usual standard of care (SC). All cause mortality (causes of death) is then investigated 14 days after the treatment for both groups.
What are the possible benefits and risks of participating?
Patients who are given the CP may have a better chance of surviving Ebola. However, they do risk having a reaction to the CP. There are no benefit to donors, other than they are given a health care assessment. Risks include bruising from the venepuncture when donating CP. Donors have their plasma replaced with saline so are not as risk of hypovolaemia (low blood volume) which could cause faintness. The greatest risk is to the healthcare workers who administer the treatment as they may become exposed to the Ebola virus.
Where is the study run from?
Ebola Treatment Unit, Freetown (Sierra Leone)
When is the study starting and how long is it expected to run for?
November 2014 to February 2016
Who is funding the study?
Wellcome Trust (grant number 106491/Z/14/Z0)
Who is the main contact?
1. Mrs V Winters (public)
vwinter1@liverpool.ac.uk
2. Dr Calum Semple (scientific)
m.g.semple@liverpool.ac.uk
Contact information
Public
Institute of Child Health
University of Liverpool
Eaton Road
Liverpool
L12 2AP
United Kingdom
| Phone | +44151 252 5606 |
|---|---|
| vwinter1@liverpool.ac.uk |
Scientific
Institute of Child Health
University of Liverpool
Alder Hey Children's Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom
 ORCID ID |
0000-0001-9700-0418 |
|---|---|
| Phone | +441512525250 |
| m.g.semple@liverpool.ac.uk |
Study information
| Study design | Emergency pragmatic phase 2/3 open-label non-randomized, controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Convalescent plasma for early Ebola virus disease in Sierra Leone: an open-label, non-randomized, controlled clinical trial |
| Study acronym | Ebola_CP |
| Study hypothesis | That transfusion of a single unit of convalescent plasma in early Ebola virus disease reduces absolute mortality by 20% |
| Ethics approval(s) | Sierra Leone Ethics and Scientific Review Committee, Ministry of Health and Sanitation, V0.3, 16/12/2014, V0.4, 07/02/2015, V0.5, 19/03/2015, ref: PBSL/CTAN/MOHS-CST001-15-002 |
| Condition | Early Ebola virus disease |
| Intervention | 1. Active Arm: A single transfusion of convalescent plasma from Ebola virus disease survivors 2. Control Arm: A single intravenous bolus of Ringer's Lactate |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Ebola Convalescent Donor Plasma (un-fractionated) |
| Primary outcome measure | All cause mortality at day 14 post intervention |
| Secondary outcome measures | 1. To compare 30 day all cause survival on CP+SC to SC+RL/0.9% saline 2. To assess the relationship between EV antibody levels in donated CP and survival 3. To assess the relationship between EV antibody levels in donated CP and changes in levels of viral RNA in the blood of patients over time 4. To assess the occurrence of serious adverse reactions (SARs) related to CP transfusion or RL/0.9% saline infusion in patients 5. To assess the occurrence of safety risks related to CP transfusion or RL/0.9% saline infusion in health workers administering the treatments 6. To determine risk factors for mortality despite administration of CP (for identification of patients most likely to benefit) 7. To determine risk factor for mortality at day 14 and day 30 |
| Overall study start date | 06/11/2014 |
| Overall study end date | 31/03/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 130 in active arm and 100 in control arm |
| Participant inclusion criteria | 1. Persons of all ages and sex admitted to Ebola treatment units with confirmed Ebola virus disease 2. Health care workers who experience a safety incident as a result of the intervention 3. Survivors of Ebola virus disease who volunteer to donate plasma |
| Participant exclusion criteria | 1. Those for whom the intervention is contraindicated 2. Those who are unresponsive (per AVPU) just prior to intervention 3. Those for whom any intervention is considered futile |
| Recruitment start date | 19/03/2015 |
| Recruitment end date | 29/02/2016 |
Locations
Countries of recruitment
- Sierra Leone
Study participating centres
Wilberforce Barracks
Freetown
-
Sierra Leone
Tower Hill
Freetown
-
Sierra Leone
Sponsor information
University/education
Waterhouse Buildings
3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom
| Phone | +44151 794 8347 |
|---|---|
| kwilding@liverpool.ac.uk | |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Charity
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | article on feasibility of donor recruitment | 01/05/2018 | 01/08/2019 | Yes | No |
| Other publications | 27/01/2021 | 17/05/2023 | Yes | No |
Editorial Notes
17/05/2023: Publication reference added.
01/08/2019: Publication reference added.
05/05/2016: The overall trial end date has been updated from 06/02/2016 to 31/03/2017 and the recruitment end date has been updated from 06/02/2016 to 29/02/2016. In addition, the target number of participants has been changed to 230 from 300 as the number of participants in the active arm has decreased from 200 to 130.
