7 |
Clinical Trial to Evaluate the Efficacy and Safety of Convalescent Plasma for Ebola Treatment [34] |
Brown J et al. |
Completed |
No |
Non-randomised, safety/efficacy study, open label, single group assignment, phase 1/2 pilot treatment trial |
6 in total (4 in intervention arm, 2 in control arm). Target in protocol was 70. |
Persons with PCR-confirmed Ebola virus, >18 years old, excluding pregnant women |
Convalescent Plasma |
Optimised standard of care alone |
Change in viral load and Ebola Virus antibody levels |
Liberia |
8 |
A Prospective, Open Label, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus Disease [35] |
Winkler A et al. |
Enrolling by invitation |
No but publication plan is in development |
Non-randomised, safety/efficacy study, single group assignment, open label, phase I treatment trial |
Enrolling by invitation (target in protocol was 12). Ebola survivors have consented to donate but no one enrolled to receive INTERCEPT plasma transfusion. |
Persons with PCR- confirmed Ebola virus |
INTERCEPT plasma |
None |
Proportion of subjects who survive Ebola (through hospital discharge up to one year) |
United States |
9 |
Treating the Host Response to Ebola Virus Disease with Generic Statins and Angiotensin Receptor Blockers [36] |
Fedson D et al. |
Completed |
No (authors state that health officials in Sierra Leone have not released reports of treatment results) |
Treating patients consecutively. |
Approximately 100 patients were treated consecutively |
Persons with confirmed Ebola virus |
Atorvastatin and irbesartan |
Historical controls receiving standard care alone |
Mortality |
Sierra Leone |
10 |
Efficacy of Favipiravir (T-705) in patients infected with Ebola virus in Sierra Leone: a preliminary clinical trial [37] |
Jiafu J et al. |
Completed |
No |
Non-randomised, double-blind trial. No trial phase stated. |
According to protocol: 85 in control group, 39 in intervention group |
Persons with PCR- confirmed Ebola virus, aged >9 and <66 years old. Excluding pregnant women. |
Favipiravir |
WHO-recommended therapies |
Death and survival |
Sierra Leone |
11 |
Convalescent plasma for early Ebola virus disease in Sierra Leone [38] |
Semple C et al. |
Completed |
No |
Emergency, non-randomized safety/efficacy study, phase 2/3, open-label clinical trial, control receives Ringer's lactate infusion. |
4 patients (3 in intervention arm). Completed but results not yet published (target in protocol was 300) |
Persons with PCR- confirmed Ebola virus, all ages. |
Convalescent Plasma |
Single intravenous bolus of Ringer's Lactate |
All-cause mortality at day 14 post intervention |
Sierra Leone |