Convalescent plasma for early Ebola virus disease in Sierra Leone

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13990511

Enrollment

230

Registered

2015-04-27

Start date

2015-03-19

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Ebola virus disease Infections and Infestations Early Ebola virus disease

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
All cause mortality at day 14 post intervention	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Sierra Leone

Contacts

Public ContactV Winters

vwinter1@liverpool.ac.uk+44151 252 5606

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026