Table 2 Drug and vaccines trials proposed, initiated, or completed during the 2013–2016 Ebola virus disease epidemic in Guinea, Liberia, and Sierra Leone
From: Protected to death: systematic exclusion of pregnant women from Ebola virus disease trials
Clinical trial registry ID | Study type (Phase)a | Intervention | Scientific title [References to publications] | Country | Status | WHO-ERC Review (WHO-supported) | Pregnant women excluded (test)a,b |
|---|---|---|---|---|---|---|---|
ISRCTN17414946 | Treatment (NS) | IFN ß-1a | A pilot study to evaluate the safety and efficacy of interferon beta-1a (IFN ß-1a) in the treatment of patients presenting with Ebola virus illness | Guinea | <10 patients enrolled, results pending [73] | No (No) | Yes (NS) |
PACTR201411000939962 | Treatment (NS) | Brincidofovir | Open-label, non-randomised single arm trial to investigate the efficacy of brincidofovir compared to historic controls for Ebola virus disease in an outbreak setting in West Africa (RAPIDE-BCV) [32] | Liberia | Completed | Yes (No) | Yes (Yes) |
NCT02329054 | Treatment (2) | Favipiravir | Efficacy of favipiravir in reducing mortality in individuals with Ebola Virus Disease in Guinea (JIKI) [38] [74] | Guinea | Completed | Yes (No) | Yes (Yes) |
NCT02662855 | Treatment (2) | Favipiravir | Efficacy of favipiravir against severe Ebola virus disease | Sierra Leone | Completed | No (No) | Yes (NS) |
ChiCTR-OCN-15007272 | Treatment (NS) | Favipiravir | Clinical and virological characteristics of Ebola Virus Disease patients treated with favipiravir (T-705) - Sierra Leone, 2014 [75] | Sierra Leone | Completed | No (No) | NS (NS) |
PACTR201501000997429 | Treatment (NS) | TKM-130803 | Open-label, single arm trial to investigate the efficacy of TKM-130803 with a concurrent observational study of Ebola virus Disease in an outbreak setting in West Africa (RAPIDE TKM) [40] [76] | Sierra Leone | Completed | No (No) | Yes (Yes) |
NCT02363322 | Treatment (1/2) | ZMapp | A multicenter randomized safety and efficacy study of putative investigational therapeutics in the treatment of patients with known Ebola infection [77] | Guinea, Liberia, Sierra Leone | Ongoing, not recruiting | No (No) | Yes (Yes) |
NCT02333578 | Treatment (NS) | Convalescent plasma | A phase I/II pilot clinical trial to evaluate the efficacy and safety of Ebola virus disease (EVD) convalescent plasma (ECP) for treatment of EVD | Liberia | Recruiting | No (No) | Yes (Yes) |
NCT02342171 | Treatment (2/3) | Convalescent plasma | Emergency evaluation of convalescent plasma for ebola viral Disease (EVD) in Guinea [39] [30] [78] | Guinea (MSF ETC Conakry) | Completed | Yes (Yes) | No |
ISRCTN13990511 | Treatment (2/3) | Convalescent Plasma | Convalescent plasma for early Ebola virus disease in Sierra Leone: an open-label, non-randomized, controlled clinical trial | Sierra Leone | Completed | No (No) | No |
NCT02509494, PACTR201506001147964 | Vaccine (3) | Ad26.ZEBOV MVA-BN-Filo | A staged Phase 3 study, including a double-blinded controlled stage to evaluate the safety and immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as candidate prophylactic vaccines for Ebola | Sierra Leone | Recruiting | No (No) | Yes (Yes) |
NCT02575456 | Vaccine (2) | Ad5-EBOV | A single-center, randomized, blind, Phase II clinical trial to evaluate the safety and immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in healthy adults in Sierra Leone | Sierra Leone | Completed | No (No) | Yes (Yes) |
NCT02876328 | Vaccine (2) | Ad26.ZEBOV, rVSVΔG/ ZEBOV-GP MVA-BN-Filo | Partnership for research on Ebola vaccinations (PREVAC) | Guinea, Liberia | Recruiting | No (No) | Yes (Yes) |
PACTR201503001057193 | Vaccine (3) | rVSVΔG/ ZEBOV-GP | A randomized trial to evaluate Ebola vaccine efficacy and safety in Guinea, West Africa. Part A: A randomized trial of ring vaccination to evaluate Ebola vaccine efficacy and safety in Guinea, West Africa. Part B: Safety and immunogenicity of rVSVΔG/ ZEBOV-GP among frontline workers [43] [72] | Guinea, Sierra Leone | Completed | Yes (Yes) | Yes (self-reported, non-obligatory test offered) |
NCT02378753, PACTR201502001037220 | Vaccine (2/3) | rVSVΔG/Z EBOV-GP | rVSVΔG-ZEBOV Ebola prevention vaccine evaluation in Sierra Leone (STRIVE) | Sierra Leone | Completed | No (No) | Yes (Yes) |
NCT02344407 | Vaccine (2) | rVSVΔG/ ZEBOV-GP, ChAd3-EBOZ | Partnership for research on Ebola vaccines in Liberia (PREVAIL) | Liberia | Active, not recruiting | No (No) | Yes (Yes) |