Table 3 Summary of clinical studies: remdesivir

Wang et al. [65]

Randomised, double-blind, placebo-controlled (n = 237)

1. Remdesivir single daily infusions 200 mg on the first day, followed by 100 mg on days 2 to 10 (n = 158)

2. Placebo (n = 79)

Primary:

Time to clinical improvement within 28 days

Secondary:

Proportions of patients

in each category on a six-point ordinal scale at day 7, 14, and 28; all-cause mortality at day 28; frequency of invasive mechanical ventilation; duration of oxygen therapy; duration of hospital admission; proportion of patients with nosocomial infection

Similar results in clinical improvement (median, 21 days in remdesivir vs 23 days in the placebo group)

Patients receiving remdesivir within 10 days of symptom onset had a faster time to clinical improvement than those receiving placebo, without statistical significance (median, 18 days vs 23 days)

Similar 28-day mortality between remdesivir and placebo (14% vs 13%)

Beigel et al. ACTT-1 [66]

Randomized, double-blind, placebo-controlled trial (n = 1062)

1. Remdesivir 200 mg loading dose on the first day, followed by 100 mg daily for up to 9 additional days (n = 541)

2. Placebo (n = 521)

Primary:

Time to recovery

Secondary:

Clinical status at day 15; time to improvement of one and of two categories from the baseline ordinal score; clinical status and mean change in status on the ordinal scale at days 3, 5, 8, 11, 15, 22, and 29; time to discharge; number of days up to day 29 with and incidence and new onset of supplemental oxygen, with non-invasive ventilation or high-flow oxygen, with invasive ventilation or ECMO; number of days of hospitalization up to day 29; mortality at days 14 and 28

Shorter time to recovery with remdesivir than with placebo (median, 10 days vs 15 days)

Odds of improvement in the ordinal scale score were higher in the remdesivir than in the placebo group

Mortality by day 15 were lower in the remdesivir group than in the placebo group (6.7% vs 11.9%)

Shorter time to clinical improvement with remdesivir than placebo (one-category improvement: median, 7 vs 9 days; two-category improvement: median, 11 vs 14 days)

Shorter time to hospital discharge with remdesivir (median, 8 days vs 12 days)

Fewer days of oxygen supplementation with remdesivir from baseline (median, 13 days vs 21 days)

Lower new incidences of oxygen supplementation in remdesivir group (36% vs 44%)

Equal median duration of non-invasive ventilation or high-flow oxygen from baseline in both groups (6 days vs 6 days)

Lower new incidences of non-invasive ventilation or high-flow oxygen use with remdesivir (17% vs 24%)

Fewer days of mechanical ventilation or ECMO from baseline with remdesivir (median, 17 days vs 20 days)

Lower new incidences of mechanical ventilation or ECMO with remdesivir than with placebo (13% vs 23%)

Serious adverse events in 24.6% in remdesivir and 31.6% in placebo group

Goldman et al. [67]

Randomised, open-label, controlled trial (n = 397)

1. 5 days of remdesivir, 200 mg on the first day, followed by 100 mg once daily for 4 days (n = 200)

2. 10 days of remdesivir, 200 mg on the first day, followed by 100 mg once daily for 9 days (n = 197)

Primary:

Clinical status on day 14

Secondary:

Proportion of adverse events occurring on or after the first dose for up to 30 days after the last dose

Clinical improvement after 14 days in 65% of the 5-day course vs 54% of the 10-day course group

Similar results in time to clinical improvement, recovery, and death between the groups after adjustment of baseline differences

Mortality by day 14 in patients receiving mechanical ventilation or ECMO at day 5 was 40% in the 5-day group vs 17% in the 10-day group

Adverse events in 70% of 5-day vs 74% in 10-day group

Spinner et al. [68]

Randomised, open-label, controlled trial (n = 584)

1. 10-day course of remdesivir, 200 mg on first day, followed by 100 mg daily (n = 197)

2. 5-day course of remdesivir, 200 mg on first day, followed by 100 mg daily (n = 199)

3. Standard of care (n = 200)

Primary:

Distribution of clinical status on day 11

Secondary:

Proportion of patients

with adverse events throughout the time of the study

Higher odds of better clinical status distribution on day 11 in 5-day group in comparison to standard of care

No statistically significant difference in clinical status distribution between 10-day and standard of care group

Adverse events were 51% in the 5-day, 59% in the 10-day, and 47% in the standard of care group

WHO Solidarity Trial [69]

Randomised, open-label, controlled trial (n = 11,330), including treatment with remdesivir, hydroxychloroquine, lopinavir, interferon vs pairwise control

1. Remdesivir 200 mg on the first day and 100 mg on the following nice days (n = 2743)

2. Standard of care (n = 2708)

Primary:

Effects on in-hospital mortality

Secondary:

Initiation of mechanical ventilation; duration of hospitalization

In-hospital mortality was 12.5% with remdesivir vs 12.7% receiving standard of care

No reduction of initiation of ventilation among patients not already on ventilation with remdesivir