Table 3.

Summary of protocol-specified efficacy end points.

End point	Dose cohort
End point	1.5 mg (N = 14^a)	2.0 mg (N = 15)	2.5 mg (N = 15)	Total (N = 44)
Mortality from Day 1 to
Day 7	—	—	—	—
Day 15	—	—	—	—
Day 31^b	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 to^c	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 load^c	Days
Mean time from baseline until undetectable viral load^c	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).