Table 2. Patient-based clinical trials of experimental therapeutics registered on clinical trial databases during the west Africa Ebola virus disease outbreak.
| Trial design | Research question (PICO model) | Registration number (declared status as of November, 2016) | Result | |
|---|---|---|---|---|
| ZMapp | Open label RCT with adaptive trial design | Intervention: 50 mg/kg ZMapp, intravenous, every 3 days, total of three doses; comparison with optimised care alone (including favipiravir in Guinea); outcome measured as day 28 survival | Registered as PACTR201503001065306, NCT02363322 (completed) | No statistically conclusive benefit108 |
| TKM-130803 | Open label, single arm, Component of a multi-stage approach | Intervention: 0⋅3 mg/kg of TKM-130803, intravenous, once daily, total of seven doses; comparison with historical controls; outcome measured as day 14 survival | Registered as PACTR201501000997429 (completed) | No overall survival benefit109 |
| Favipiravir | Open label, single arm | Intervention: 6000 mg (day 0) and 2400 mg (days 1–9), oral, daily of favipiravir, total of ten doses; comparison with historical controls; outcome measured as day 14 survival | Registered as NCT02329054 (completed) | No overall survival benefit50 |
| Convalescent plasma | Open label, single arm | Intervention: 400–500 mL of convalescent plasma from two donors, administered as two consecutive (200–250 mL) transfusions; one treatment cycle in total; comparison with historical controls; outcome measured as day 14 survival | Registered as NCT02342171 (completed) | No overall survival benefit71 |
| Convalescent plasma | Open label, single arm | Intervention: 180–220 mL of convalescent plasma from two donors, administered as two consecutive (90–110 mL) infusions; up to three treatment cycles, at least 48 h apart; no comparison made; outcome measured as Ebola virus load | Registered as NCT02333578 (recruiting) | NA |
| Convalescent plasma | Open label, single arm | Intervention: INTERCEPT plasma; dose not defined; comparison not defined; outcome measured as 1 year survival | Registered as NCT02295501 (open to enrolment) | NA |
| Convalescent plasma | Open label, random allocation | Intervention: single transfusion of convalescent plasma; dose not defined; comparison with Ringer’s Lactate solution; outcome measured as all-cause mortality as 14 days after treatment | Registered as ISRCTN13990511 (ongoing; no longer recruiting) | NA |
| Brincidofovir | Open label, single arm trial, component of a multistage approach | Intervention: 200 mg brincidofovir oral, initial dose, then 100 mg, oral, twice weekly; total of five doses; comparison with historical controls; outcome measured as day 14 survival | Registered as PACTR201411000939962 (recruitment suspended) | No statistical conclusion110 |
| Azithromycin, Sunitinib, Erlonitib, Atorvastatin, Irbesartan | Multi-arm RCT with adaptive trial design | Intervention: azithromycin (1500 mg, oral, daily for 5 days) vs sunitinib (50 mg, oral, daily for 7 days) and erlonitib (150 mg, oral, daily for 7 days) vs atorvastatin (40 mg, oral, daily until discharge) and irbesartan (150 mg, oral, daily until discharge); comparison with intravenous fluids and laboratory testing alone; outcome measured as day 14 survival | Registered as NCT02380625 (not yet open to recruitment) | NA |
| Interferon β | Open label, single arm | Intervention: subcutaneous interferon β once daily for up to 10 days; comparison not defined (safety and effectiveness study); undefined outcome | Registered as ISRCTN17414946 (completed) | NA |
| Amiodarone | Open label, RCT | Intervention: amiodarone (20 mg/kg, intravenous, on days 1–3 then 200 mg, oral, three times daily, on days 4–10); comparison with supportive care alone; outcome measured as day 10 survival | Registered as NCT02307591 and PACTR201501001014425 (withdrawn) | NA |
Where a dose of an intervention has been stated, it refers to the stated adult dose. Refer to trial protocols for weight adjustment. PICO=participant, intervention, comparison, outcome. RCT=randomised controlled trial. NA=not available.