6/28/23, 12:01 AM ACTT-1 Pathway Feedback Search Clinical Topics Home Studies ACTT 1 ACTT 1 Disease COVID 19 infection 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 N = 1062 64.0% male 1062 patients (378 female, 684 male) Inclusion criteria: adults 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) https://web.pathway.md/studies/recN0EVi46N7Aw4g5 1/2 6/28/23, 12:01 AM ACTT-1 Pathway Primary outcome Time to recovery 15.0 days 15 11.3 days 10 7.5 days 3.8 days Significant increase 0.0 days Remdesivir Placebo 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 adults 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. Open reference URL https://web.pathway.md/studies/recN0EVi46N7Aw4g5 2/2