Table 3.
Summary of protocol-specified efficacy end points.
| End point | Dose cohort | |||
|---|---|---|---|---|
| 1.5 mg (N = 14a) | 2.0 mg (N = 15) | 2.5 mg (N = 15) | Total (N = 44) | |
| Mortality from Day 1 to | ||||
| Day 7 | — | — | — | — |
| Day 15 | — | — | — | — |
| Day 31b | 1 (7.1) | — | 1 (6.7) | 2 (4.5) |
| Patients requiring invasive mechanical ventilation and/or intensive care unit admission | ||||
| Day 1 to Day 7 | 2 (14.3) | 1 (6.7) | 2 (13.3) | 5 (11.4) |
| Day 8 to Day 15 | 1 (7.1) | 1 (6.7) | 1 (6.7) | 3 (6.8) |
| Day 16 to Day 31 | 1 (7.1) | 1 (6.7) | 1 (6.7) | 3 (6.8) |
| Day 1 to Day 31 | 2 (14.3) | 1 (6.7) | 3 (20.0) | 6 (13.6) |
| Patients requiring noninvasive mechanical ventilation | ||||
| Day 1 to Day 7 | 4 (28.6) | 0 | 1 (6.7) | 5 (11.4) |
| Day 8 to Day 15 | 3 (21.4) | 0 | 2 (13.3) | 5 (11.4) |
| Day 16 to Day 31 | 1 (7.1) | 1 (6.7) | 1 (6.7) | 3 (6.8) |
| Day 1 to Day 31 | 5 (35.7) | 1 (6.7) | 2 (13.3) | 8 (18.2) |
| Patients requiring oxygen therapy at | ||||
| Day 7 | 12 (85.7) | 12 (80.0) | 11 (73.3) | 35 (79.5) |
| Day 15 | 4 (28.6) | 1 (6.7) | 4 (26.7) | 9 (20.5) |
| Day 31 | 0 | 2 (13.3) | 1 (6.7) | 3 (6.8) |
| Day 1 to Day 31 | 12 (85.7) | 12 (80.0) | 11 (73.3) | 35 (79.5) |
| Mean change in viral load from baseline toc | log10 copies/ml | |||
| Day 4 | −1.23 | −1.49 | −1.32 | −1.35 |
| Day 7 | −2.55 | −2.26 | −2.25 | −2.35 |
| Day 15 | −4.22 | −2.70 | −2.92 | −3.25 |
| Day 31 | −4.70 | −3.53 | −3.49 | −3.85 |
| Mean time from baseline until undetectable viral loadc | Days | |||
| 11 | 14 | 14 | 13 | |
a
One patient who experienced an anaphylactic reaction during the first plitidepsin infusion had treatment discontinued and was not considered evaluable for efficacy.
b
One additional patient treated at 2.5 mg/day died on Day 57, because of COVID-19 complications.
c
Results based on 42 patients at Day 4 (13 at 1.5 mg, 14 at 2.0 mg, 15 at 2.5 mg), 40 patients at Day 7 (13 at 1.5 mg, 14 at 2.0 mg, 13 at 2.5 mg), 38 patients at Day 15 (12 at 1.5 mg, 13 at 2.0 mg, 13 at 2.5 mg), and 39 patients at Day 31 (11 at 1.5 mg, 14 at 2.0 mg, 14 at 2.5 mg).