6/29/23, 1:37 AM PINETREE Pathway Feedback Search Clinical Topics Home Studies PINETREE PINETREE Disease COVID 19 infection Trial question What is the effect of remdesivir in nonhospitalized patients who are at high risk for COVID-19 progression? Study design Multi-center Double blinded RCT Population Characteristics of study participants 48.0% female N = 562 52.0% male 562 patients (269 female, 293 male) Inclusion criteria: nonhospitalized patients with COVID-19 who had at least one risk factor for disease progression Key exclusion criteria: receipt of supplemental oxygen or hospital care; previous hospitalization for COVID-19; previous treatment for COVID-19; receipt of SARS-CoV-2 vaccine Interventions N=279 remdesivir (intravenous dose of 200 mg on day 1 and 100 mg on day 2 and 3) N=283 placebo (matching placebo on day 1 to 3) Primary outcome https://web.pathway.md/studies/recDcKtjWoKdN8pR9 1/2 6/29/23, 1:37 AM PINETREE Pathway Hospitalization related to COVID-19 or death from any cause at day 28 5.3 % 5.3 4.0 % 2.6 % Significant decrease 1.3 % NNT = 22 0.7 0.0 % Remdesivir Placebo Significant decrease in hospitalization related to COVID-19 or death from any cause at day 28 (0.7% vs. 5.3%; HR 0.13, 95% CI 0.03 to 0.59) Secondary outcomes Borderline significant decrease in medically attended visit related to COVID-19 or death from any cause at day 28 (1.6% vs. 8.3%; HR 0.19, 95% CI 0.07 to 0.56) Borderline significant decrease in hospitalization for any cause at day 28 (1.8% vs. 6.4%; HR 0.28, 95% CI 0.1 to 0.75) No significant difference in alleviation of symptoms at day 14 (34.8% vs. 25%; RR 1.41, 95% CI 0.73 to 2.69) Safety outcomes No significant differences in adverse events, nasopharyngeal viral load at day 7. Conclusion In nonhospitalized patients with COVID-19 who had at least one risk factor for disease progression, remdesivir was superior to placebo with respect to hospitalization related to COVID-19 or death from any cause at day 28. Reference Robert L Gottlieb, Carlos E Vaca, Roger Paredes et al. Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N Engl J Med. 2022 Jan 27;386(4):305-315. Open reference URL https://web.pathway.md/studies/recDcKtjWoKdN8pR9 2/2