Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201602001355272 Date of Approval: 20/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ebola_CP
Official scientific title Convalescent Plasma for Early Ebola Virus Disease in Sierra Leone
Brief summary describing the background and objectives of the trial West Africa experienced the worst outbreak of Ebola viral disease(EVD)ever witnessed.A key factor contributing to the high mortality is the lack of any proven effective EVD specific treatment. Convalescent whole blood(CWB)and plasma(CP)were prioritized as an EVD treatment option by WHO.CP is a medical intervention successfully applied for other serious infectious diseases and generally considered safe. Nevertheless, better evidence needs to be generated as a treatment option for EVD. As to the administration of CWB and CP,human clinical data is limited. The most important study dates from 1999,reporting on eight individuals treated with CWB during the Kikwit epidemic in 1995, with seven surviving(Mupapa,JID1999).This was an uncontrolled small study with patients enrolled relatively late after symptom onset and improved hydration and other components in blood like clotting factors may have improved survival. Consequently, the effectiveness of this treatment is stilldebated and it has not been implemented as a routine EVD treatment intervention. This is an emergency phase2/3,open-label,non-­randomized, controlled clinical trial comparing outcome for standardized supportive care(SC)+CP with SC+ equivalent volume of Ringer¿s Lactate(or 0.9%Saline or crystalloid of choice for standard care in that ETU)in patients with confirmed EVD. The primary objective of the study is to assess if SC+CP improves the survival of patients, compared to SC+RL at 14 days after intervention(due to the presence of other blood components in CP,this study will not provide definite evidence that any increased survival associated with CP is(only) due to the transfer of EV antibodies. Other objectives include tocompare30day all cause survival on CP+SCto SC+RL/0.9%Saline,assess the relationship between EVantibodylevels in donatedCP and survival, assess the relationship between EVantibodylevels in donated CP and changes in the levels of viral RNA in the blood of patients over time
Type of trial CCT
Acronym (If the trial has an acronym then please provide) CCT
Disease(s) or condition(s) being studied ,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/02/2015
Actual trial start date 19/03/2015
Anticipated date of last follow up 07/11/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants) 4
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
MOHS-­¿CST001 Ministry of Health, Sierra Leone
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Non-randomised Not applicable Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Convalescent Plasma Transfusion of approximately  450ml  (+/-­¿  25ml)  CP  where  available   per  in/exclusion  criteria  or  if  child  or  small  adult  <  45kg  then  1 over 30 minutes Vitals are monitored 15 minutes before, during and up to one hour post inntervention. Bllod draws are also taken before and after transfusion for viral load and serology. 4
Experimental Group Convalescent Plasma Transfusion of approximately  450ml  (+/-­¿  25ml)  CP  where  available   per  in/exclusion  criteria  or  if  child  or  small  adult  <  45kg  then  1 over 30 minutes Vitals are monitored 15 minutes before, during and up to one hour post intervention. Blood draws are also taken before and after transfusion for viral load and serology. 4
Control Group Ringers Lactate/Normal Saline Infusion  of  Ringer¿s  Lactate  solution  or  0.9%  Saline  approximately   450ml  (+/-­¿  25ml)  or  if  child  or  small  adult  <  45kg  then  10  ml/kg over 30 minutes Where compatible Plasma is unavailble or if a patient refuses the intervention Ringers Lactate/0.9% Saline is transfused as per crystalloid of choice for standard care in the ETU. Vitals are monitored 15 minutes before, during and up to one hour post intervention. Blood draws are also taken before and after the infusion for viral load and serology. 1 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any  age     - Pregnant  women  are  permitted  to  enter  the  study   - PCR-­¿confirmed,  symptomatic  infection  with  EV   -­¿   Ability  for  informed  consent  to  participate  in  the  study  to  be  obtained:    -­¿     For  adults  (as  defined  by  local  regulations):  written  (signature  or  thumb  print)  by  patient  or   culturally  acceptable  guardian  if  patient  considered  unable  to  fully  comprehend  and  provide   informed  consent   -­¿     For  younger  ages  (<18  yrs  old):  consent  by  parent  or  culturally  acceptable  guardian      History  of  allergic  reaction  to  blood  or  plasma  products  (as  judged  by  the  investigator  or   treating  doctor)   -­¿            Medical  conditions  in  which  receipt  of  450-­¿500ml  volume  or  10ml/kg  (for  those  weight  <45kg)   may  be  detrimental  to  the  patient  (e.g.  decompensated  congestive  heart  failure)   -­¿   Unresponsive  on  AVPU  score  (Alert,  Voice  Responsive,  Pain  Responsive,  Unresponsive)  just  prior   to  intervention    Futility:  those  patients  with  late  presentation  of  EVD  in  whom  treatment  is  considered  too   late  to  be  effective,  e.g.  shock  not  responding  to  fluid  challenge  or  severe  haemorrhage    Inability  to  cannulate  a  vein  for  any  reason   0 Year(s) 0 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/02/2015 Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Connaught Hospital Freetown Sierra Leone
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome All-­¿cause  mortality  at  day  14  after  the  intervention     Day 14 after intervention
Secondary Outcome 30  day  all-­¿cause  mortality  after  the  intervention   30 days after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
34 Military Hospital Wilberforce Freetown Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome  Trust London United Kingdom
Bill and Melinda Gates Foundation United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University  of  Liverpool   765 Brownlow Hill Liverpool L69 8ZX United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Ministry  of  Health  and  Sanitation,  Government  of  Sierra  Leone   Freetown Sierra Leone
Institute  of  Translational  Medicine, University of Liverpool Liverpool United Kingdom
College  of  Medicine  and  Health  Science  (COMAHS) University of Sierra Leone Freetown Sierra Leone
Institute  of  Tropical  Medicine, Antwerp Brussels Belgium
Institute  of  Tropical  Medicine  (Charité) Berlin Germany
National  Blood  Service, Freetown Sierra Leone
Liverpool  School  of  Tropical  Medicine Liverpool United Kingdom
Nuffield  Department  of  Medicine University of Oxford United Kingdom
MRC  Tropical  Epidemiology  Group  London  School  of  Hygiene  and  Tropical   Medicine  (LSHTM) London United Kingdom
NHS  Blood  and  Transplant  Service United Kingdom
Rare  and  Imported  Pathogens  Laboratory  (RIPL)  &  Blood  Borne  Viruses  Unit   (BBVU),  Public  Health  England   United Kingdom
World  Health  Organization  (WHO) Geneva Switzerland
International  Severe  Acute  Respiratory  and  Emerging  Infection  Consortium   (ISARIC)  
Roslin  Institute University of Edinburgh United Kingdom
ClinicalRM Hinckley Ohio United States of America
University  of  North  Carolina Chapel Hill United States of America
ClinicalRM Hinckley Ohio United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sahr Moses Gevao gevaosm@yahoo.com +232 76 601613 Ministry of Health and Sanitation, Sierra Leone
City Postal code Country Position/Affiliation
Sierra Leone Consultant Haematologist
Role Name Email Phone Street address
Public Enquiries Christine Cole cpcole2003@yahoo.co.uk +232 76 927013 Connaught Hospital
City Postal code Country Position/Affiliation
Freetown Sierra Leone Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Malcolm Semple M.G.Semple@liverpool.ac.uk +44 (0) 151 252 5456 University of Liverpool
City Postal code Country Position/Affiliation
Waterhouse  Buildings L69  3GL United Kingdom Consortium Lead and Coordinating Investigator
REPORTING
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