ACTT-1
Trial question
What is the role of remdesivir in patients hospitalized with COVID-19 who have evidence of lower respiratory tract infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 1062
1062 patients (378 female, 684 male)
Inclusion criteria: adult patients who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection
Key exclusion criteria: alanine transaminase or aspartate transaminase > 5 times the ULN, eGFR < 30 ml/min, pregnancy or breastfeeding, allergy to any study medication
Interventions
N=541 remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days)
N=521 placebo (matching placebo or normal saline for up to 10 days)
Primary outcome
Time to recovery
10
15
15.0 days
11.3 days
7.5 days
3.8 days
0.0 days
Remdesivir
Placebo
Significant increase ▲
Significant increase in time to recovery (10 days vs. 15 days; RR 1.29, 95% CI 1.12 to 1.49)
Secondary outcomes
Borderline significant increase in clinical improvement at day 15 (with an ordinal score of 1) (29% vs. 22.1%; OR 1.5, 95% CI 1.2 to 1.9)
No significant difference in the rate of death by day 29 (11.4% vs. 15.2%; HR 0.73, 95% CI 0.52 to 1.03)
Borderline significant increase in median time to discharge (8 days vs. 12 days; HR 1.27, 95% CI 1.1 to 1.46)
Safety outcomes
No significant difference in grade 3 or 4 adverse events and nonserious adverse events.
Significant differences in serious adverse events (24.6% vs. 31.6%), serious respiratory failure adverse events (8.8% vs. 15.5%).
Conclusion
In adult patients who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection, remdesivir was superior to placebo with respect to time to recovery.
Reference
John H Beigel, Kay M Tomashek, Lori E Dodd et al. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826.
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