Table 2.
Human clinical data
Compound/drug | EBOV clinical trial phase | Results/status | Other clinical data |
---|---|---|---|
BCX4430 | Phase I (NCT02319772) | Phase I complete; results not available yet | N/A |
Brincidofovir | Phase II (NCT02271347) | Terminated due to low enrollment; not currently under further development as EBOV therapeutic [73] | Administered to 5 patients during the outbreak, often in combination with other therapies [52, 74] |
GS-5734 | Phase I | Phase I complete; Phase II for efficacy in survivors with viral persistence in semen (NCT02818582) | Administered to a newborn in combination with ZMapp and buffy coat transfusion; patient survived [75] |
TKM-100802 | Phase I (NCT02041715) | Terminated | 100802 administered to two patients in combination with convalescent plasma; both survived [76] |
TKM-130803 | Phase II (PACTR201501000997429) | Terminated early; did not demonstrate efficacy [77]; development has been suspended | |
Favipiravir (T-705) | Phase II (NCT02329054: JIKI; NCT02662855: Sierra Leone) | Efficacy in patients with low to moderate levels of virus (Ct values >20) [78] | Administered with ZMab to a patient who recovered [79]; administered to a patient with convalescent plasma who recovered [80]; retrospective study indicated increased survival and lower viral loads [81] |
ZMapp | Phase II (NCT02363322) | Inconclusive efficacy due to insufficient statistical power [82••] | Administered to patients during the outbreak, often in combination with other therapies |
AVI-6002/ AVI-7537 | Phase I (AVI-6002: NCT01353027; AVI-7537: NCT01593072) | 6002: Favorable safety and tolerability 7537: Terminated prior to enrollment; further development has been suspended | N/A |
IFN-β | Phase I/II (ISRCTN17414946) | Results not yet released | N/A |
Amiodarone | Phase II (NCT02307591) | Terminated early; reduction in case-fatality rate; not statistically significant | – |
Convalescent plasma/blood | Phase I/II: NCT02333578 Phase II/III (NCT02342171; ISRCTN13990511) |
Completed; results from one study found no improvement in efficacy in treated group [83] | Whole blood: 1995 Kikwit outbreak—7 out of 8 survivors [84]; administered to patients during the outbreak, often in combination with other therapies |
FX-06 | N/A | Not under current investigation for EBOV indication | 2014: 3-day treatment course (400 mg/kg loading dose +200 mg/kg maintenance dose) was administered to a patient in combination with self-administration of amiodarone and intermittent treatment with favipiravir; patient survived [27] |