Table 2.

Efficacy of remdesivir in hospitalized patients with moderate or severe COVID-19 in the phase III SIMPLE trials

Endpoints	SIMPLE-severe [30]		SIMPLE-moderate [35]
	5-day REMa (n = 200)	10-day REMa (n = 197)	5-day REMa (n = 191)	10-day REMa (n = 193)	SOC (n = 200)
Clinical status at day 11 [35] or 14 [30]b (% of pts)
1: Death	8	11	0	1	2
2: Hospitalized, requiring IMV or ECMO	8	17	0	1	2
3: Hospitalized, requiring NIV or high-flow O2	4	5	3	0	4
4: Hospitalized, requiring low-flow supplemental O2	10	7	4	6	6
5: Hospitalized, not requiring supplemental O2 but requiring ongoing medical care	6	7	20	23	23
6: Hospitalized, not requiring supplemental O2 or ongoing medical care	4	2	4	5	4
7: Not hospitalized	60	52	70	65	60
Clinical improvementc (% of pts)
Day 5	16	15	32	37	33
Day 7	36	27	56	48	47
Day 11	58	49	70	65	61
Day 14	64	54	76	77	68
Day 28	NR	NR	90	90	83
Recoveryd (% of pts)
Day 5	16	14	35	38	36
Day 7	36	26	60	49	51
Day 11	58	49	74	68	64
Day 14	64	54	80	79	73
Day 28	NR	NR	92	92	85

Efficacy was assessed in randomized pts who received ≥ 1 dose of REM (or for the SOC group, had the day-1 visit)

BL baseline, ECMO extracorporeal membrane oxygenation, IMV invasive mechanical ventilation, NIV non-invasive ventilation, NR not reported, O₂ oxygen, pts patients, REM remdesivir, SOC standard of care

^aIntravenous infusion of 200 mg on day 1 and 100 mg on subsequent days

^bPrimary endpoint, measured on a 7-point ordinal scale

^cDefined as improvement of ≥ 2 points from BL on a 7-point ordinal scale

^dDefined as improvement from a BL score of 2–5 to a score of 6–7 [30, 35] or from a BL score of 6 to a score of 7 [35]