Condition category
Infections and Infestations
Date applied
20/04/2015
Date assigned
27/04/2015
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Mrs V Winters

ORCID ID

Contact details

Institute of Child Health
University of Liverpool
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44151 252 5606
vwinter1@liverpool.ac.uk

Type

Scientific

Additional contact

Dr Calum Semple

ORCID ID

http://orcid.org/0000-0001-9700-0418

Contact details

Institute of Child Health
University of Liverpool
Alder Hey Children's Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom
+441512525250
m.g.semple@liverpool.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol number: MOHS-CST001; Pan African Clinical Trials Registry number: PACTR201602001355272

Study information

Scientific title

Convalescent plasma for early Ebola virus disease in Sierra Leone: an open-label, non-randomized, controlled clinical trial

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

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

Study design

Emergency pragmatic phase 2/3 open-label non-randomized, controlled clinical trial

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 contact details to request a participant information sheet

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

Phase

Phase II/III

Drug names

Ebola Convalescent Donor Plasma (un-fractionated)

Primary outcome measures

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 trial start date

06/11/2014

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

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 type

Mixed

Age group

All

Gender

Both

Target number of participants

130 in active arm and 100 in control arm

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

Trial participating centre

Ebola Treatment Unit
34th Regiment Military Hospital Wilberforce Barracks
Freetown
-
Sierra Leone

Trial participating centre

Blood Service
Connaught Hospital Tower Hill
Freetown
-
Sierra Leone

Sponsor information

Organisation

University of Liverpool

Sponsor details

Waterhouse Buildings
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44151 794 8347
kwilding@liverpool.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Wellcome Trust (grant number: 106491/Z/14/Z0)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.