Table 3.

Summary of protocol-specified efficacy end points.

End pointDose 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 31b1 (7.1)1 (6.7)2 (4.5)
Patients requiring invasive mechanical ventilation and/or intensive care unit admission
 Day 1 to Day 72 (14.3)1 (6.7)2 (13.3)5 (11.4)
 Day 8 to Day 151 (7.1)1 (6.7)1 (6.7)3 (6.8)
 Day 16 to Day 311 (7.1)1 (6.7)1 (6.7)3 (6.8)
 Day 1 to Day 312 (14.3)1 (6.7)3 (20.0)6 (13.6)
Patients requiring noninvasive mechanical ventilation
 Day 1 to Day 74 (28.6)01 (6.7)5 (11.4)
 Day 8 to Day 153 (21.4)02 (13.3)5 (11.4)
 Day 16 to Day 311 (7.1)1 (6.7)1 (6.7)3 (6.8)
 Day 1 to Day 315 (35.7)1 (6.7)2 (13.3)8 (18.2)
Patients requiring oxygen therapy at
 Day 712 (85.7)12 (80.0)11 (73.3)35 (79.5)
 Day 154 (28.6)1 (6.7)4 (26.7)9 (20.5)
 Day 3102 (13.3)1 (6.7)3 (6.8)
 Day 1 to Day 3112 (85.7)12 (80.0)11 (73.3)35 (79.5)
Mean change in viral load from baseline toclog10 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 loadcDays
11141413
  • 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).