Table 1.
Randomized trial and non-randomized studies of anti-Ebola therapies
| Agent Citation |
Setting (n centres) | Intervention group (n included in analysis) | Control group (n included in analysis) |
|---|---|---|---|
| Randomized clinical trial | |||
| ZMapp PREVAIL II Writing group, 2016 [24] |
Liberia, Sierra Leone, Guinea, USA (11 centres) | ZMapp 50 mg/kg IV every 3 days (n = 36) | Standard carea (n = 35) |
| Non-randomized single-arm intervention study with concurrent controls | |||
| TKM-130803 Dunning et al., 2016 [25] |
Port Loko, Sierra Leone (1 centre) | TKM-130803 infusion 0.3 mg/kg IV daily for up to 7 days (n = 12) | Standard carea (n = 3) |
| Convalescent whole blood Sahr et al., 2017 [26] |
Wilberforce and Hastings, Freetown, Sierra Leone (2 centres) | Convalescent whole blood 450 ml (n = 43) | Standard carea (n = 25) |
| Interferon β-1a Konde et al., 2017 [27]b |
Coyah, Guinea (1 centre for intervention and the majority of control patients) | Interferon-β-1a 30 μg subcutaneously (n = 9) | Standard carea (n = 38) |
| Non-randomized single-arm intervention study with historical controls | |||
| Convalescent plasma van Griensven et al., 2016 [28] |
Conakry, Guinea (1 centre) | Convalescent plasma 200–250 ml (or 10 ml/kg if < 45 kg); two consecutive transfusions with each unit obtained from a separate convalescent donor (n = 84) | Standard carea (n = 418) |
| Favipiravir Sissoko et al., 2016 [29] |
Guinea (Conakry, Gueokedou, Macenta, Nzerekore) (4 centres for intervention patients; control patients from Guinea) | Favipiravir (oral) 6000 mg on day 0, then 2400 mg daily on days 1 to 9 (n = 111) | Standard carea (n = 540) c |
| Favipiravir Bai et al., 2016 [30] |
Jui Town, Sierra Leone (1 centre) | Favipiravir T-705 (oral) 800 mg twice on day 0 and two doses of 600 mg on subsequent days, ranging from 3 to 11 days, until discharge, transfer, or death (n = 39) | Standard care (IV fluids limited)a (n = 85) |
| Non-randomized single-arm intervention study without controls | |||
| Brincidofovir Dunning et al., 2016 [31] |
Monrovia, Liberia (1 centre) | Brincidofovir (oral) on day 0, 3, 7, 10, and 14 + standard carea (n = 4) | None |
| Retrospective cohort study | |||
| Artesunate-amodiaquine Gignoux et al., 2016 [32] |
Foya, Lofa County, Liberia (1 centre) | Artesunate-amodiaquine (n = 71) | Artemether-lumefantrine (n = 194); no anti-malarial drugs (n = 63) |
Abbreviations: USA United States of America
aStandard care and supportive care include any of intravenous fluids, antimicrobial and anti-malarial treatment, electrolyte replacement, medications for symptomatic management, nutritional support, laboratory tests, and hemodynamic monitoring. Medications, laboratory tests, and frequency of hemodynamic monitoring varied among each respective treatment centre
bThis study uses the term ‘historical controls’, but reports that 21 of the 38 controls were recruited at the same time and in the same centre as patients in the intervention arm [27]. The remaining 17 controls were treated in other centres in Guinea. We therefore classified the study as using concurrent controls
cThis study presents data on mortality in historical controls in an appendix and used these data to calculate the sample size