Table 1.
Country or countries | Study design | Number of patients randomly assigned | Mean age, years |
Sex |
Pregnancy test positive in female patient | Mean Ct value at baseline | Proportion with Ct value ≤22 at baseline | Mean duration of symptoms at baseline, days | Overall mortality | Treatment doses and schedules | Outcomes | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Male | Female | ||||||||||||
PREVAIL II; Davey et al (2016)5 | Guinea, Liberia, Sierra Leone, and the USA | Two treatment arms (ZMapp vs standard care) | 72 | 26·1 (17·4) | 32/72 (44%) | 40/72 (56%) | 0/40 | 23·9 (5·3) | 30/72 (42%) | 4·2 (2·7) | 21/71 (30%) | ZMapp (50 mg/kg of bodyweight every third day for a total of three doses) and standard care | Mortality; serious adverse events; time to viral clearance; andduration of admission |
PALM; Mulangu et al (2019)6 | Democratic Republic of the Congo | Four treatment arms (ZMapp vs remdesivir vs mAb114 vs REGN-EB3) | 681 | 28·8 (17·6) | 299/673 (44%) | 374/673 (56%) | 17/374 (5%) | 24·0 (5·6) | 282/670 (42%) | 5·5 (3·5) | 290/673 (43%) | ZMapp (50 mg/kg of bodyweight every third day beginning on day 1 for a total of three doses); remdesivir (loading dose on day 1 [200 mg in adults and adjusted for bodyweight in children], followed by a daily maintenance dose [100 mg in adults and adjusted for bodyweight in children] starting on day 2 and continuing for 9–13 days, depending on viral load); mAb114 (single infusion of 50 mg/kg on day 1); and REGN-EB3 (single infusion of 150 mg/kg on day 1) | Mortality; serious adverse events; andtime to viral clearance |
Data are mean (SD) or n/N (%). Ct=cycle threshold.