Table 1.
Description of registered clinical trials that enrol participants with acute Ebola virus disease to assess efficacy or safety, or both, of new therapies by registration number
| Ebola virus disease diagnosis | Location | Recruitment status | Sponsor | Main outcome | Size (design)* | Intervention model | Patent | First received | Anticipated completion date | |
|---|---|---|---|---|---|---|---|---|---|---|
| Randomised | ||||||||||
| NCT02307591; PACTR201501001014425 | Laboratory confirmed | Sierra Leone | Not recruiting | Emergency Onlus | Safety, efficacy | Up to 132 in two groups (parallel assignment)† | Amiodarone + sSC vs sSC alone | Expired | Nov 21, 2014 | August, 2015 |
| NCT02363322 | Laboratory confirmed | USA | On invitation | NIAID, USA | Safety, efficacy | Up to 1000 in two groups (parallel assignment)† | ZMapp + sSC vs sSC alone | Mapp Bio | Feb 13, 2015 | December, 2016 |
| Non-randomised | ||||||||||
| PACTR201411000939962 | Laboratory confirmed | Liberia | Withdrawn | University of Oxford | Safety, efficacy | 140 (single arm) | 140 brincidofovir vs HCC | Chimerix‡ | Nov 14, 2014 | June, 2015 |
| NCT02342171 | Laboratory confirmed | Guinea | Not recruiting | ITM, Belgium | Safety, efficacy | Up to 400 in two groups (convenient allocation)§ | ECP + sSC vs sSC in HCC | NA | Jan 12, 2015 | October, 2015 |
| ChiCTR-OON-14005558 | Clinical | Sierra Leone | Recruiting | China Army | Efficacy | Up to 60 in two groups (convenient allocation)¶ | QBD + XBJ + ST vs western drugs‖ | NA | Nov 29, 2014 | .. |
| NCT02333578 | Laboratory confirmed | Liberia | Recruiting | Clinical RM | Safety, efficacy | 70 (single arm) | ECP vs HCC | NA | Jan 5, 2015 | June, 2015 |
| NCT02329054 | Laboratory confirmed | Guinea | Recruiting | INSERM, France | Safety, efficacy | 225 (single arm)†** | Favipriravir + sSC vs HCC | Toyama Chemical | Dec 16, 2014 | June, 2015 |
| NCT02295501 | Laboratory confirmed | USA | Recruiting | Cerus Corporation | Safety, efficacy | 12 (single arm) | INTERCEPT†† ECP | Cerus Corporation | Nov 4, 2015 | January, 2016 |
| NCT02271347; EUDRA-2014–004450–33 | Laboratory confirmed | Europe, North America | Withdrawn | Chimerix UK Limited | Safety, efficacy | 50 (single arm) | Brincidofovir | Chimerix‡ | Oct 7, 2014 | .. |
| PACTR201501000997429 | Laboratory confirmed | Sierra Leone | Not recruiting | University of Oxford | Safety, efficacy | 100 (single arm) | TKM-Ebola | Tekmira | Jan 16, 2015 | June, 2015 |
| JPRN-UMIN000016101 | Laboratory confirmed | Japan | Not recruiting | NCGHM, Japan | Safety, efficacy | 5 (single arm) | Favipriravir | Toyama Chemical | Jan 2, 2015 | .. |
sSC=standardised supportive care (ie, in comparative studies when standardised control treatment is reported). HCC=historical or concurrent controls (non-random). ECP=Ebola convalescent plasma. NA=not applicable. QBD=Qingwenbaidu decoction (herbal product). XBJ=Xuebijing injection (herbal product). ST=symptomatic therapy.
No study uses allocation concealment (masking).
Adaptive design (ie, any deign that uses interim analyses to modify study design).
On Feb 1, 2015, Chimerix said it would stop participation in clinical studies because of a substantial decrease in the number of new cases of Ebola virus disease.
No patient will be refused ECP; control will be patients with Ebola virus disease recruited during the period before ECP becomes available or for whom no compatible convalescent plasma is available.
Allocation on voluntary base.
If western drug (ie, not traditional Chinese medicine) and ST are unspecified the study is reported as observational.
Final analysis will be done according to three different groups: (A1) adults with time between first symptoms and first dose of favipiravir (<72 h); (A2) adults with time between first symptoms and first dose of favipiravir ≤72 h; and (C) all children.
INTERCEPT is a US Food and Drug Administration approved system for ex-vivo preparation of plasma to reduce the risk of transfusion-transmitted infection during treatment of patients needing therapeutic plasma transfusion.