6/28/23, 11:10 PM Hung Pathway Feedback Search Clinical Topics Home Studies Hung Hung Disease COVID 19 infection Trial question What is the effect of the triple combination of interferon -1b, lopinavir-ritonavir, and ribavirin in the treatment of patients hospitalized with COVID-19? Study design Multi-center Open label RCT Population Characteristics of study participants 46.0% female N = 127 54.0% male 127 patients (59 female, 68 male) Inclusion criteria: adult hospitalized patients with COVID-19 Key exclusion criteria: inability to comprehend and to follow all required study procedures, allergy or severe reactions to the study drugs, known prolonged QT or PR interval, second- or third-degree heart block, or ventricular cardiac arrhythmias, known history of severe depression, pregnant or lactating women Interventions N=86 combination (lopinavir 400 mg and ritonavir 100 mg every 12 hours, ribavirin 400 mg every 12 hours, and three doses of 8 million IUs of interferon -1b on alternate days for a total of 14 days) N=41 control (lopinavir 400 mg and ritonavir 100 mg every 12 hours for 14 days) Primary outcome https://web.pathway.md/studies/rec6YWTsCLGFZ4iR5 1/2 6/28/23, 11:10 PM Hung Pathway Time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 12.0 days, 12 9.0 days, 7 6.0 days, 3.0 days, Significant decrease 0.0 days, Combination Control Significant decrease in time to providing a nasopharyngeal swab negative for SARS-CoV-2 (7 days, vs. 12 days,; HR 0.22, 95% CI 0.09 to 0.53) Secondary outcomes Significant decrease in time to complete alleviation of symptoms (4 days vs. 8 days; HR 0.255, 95% CI 0.1 to 0.6) Significant decrease in time to Sequential Organ Failure Assessment score of 0 (3 days vs. 8 days; HR 0.52, 95% CI 0.28 to 0.97) Significant decrease in median hospital stay (9 days vs. 14.5 days; HR 0.36, 95% CI 0.16 to 0.83) Safety outcomes No significant differences in adverse events, self-limiting nausea and diarrhea. Conclusion In adult hospitalized patients with COVID-19, combination was superior to control with respect to time to providing a nasopharyngeal swab negative for SARS-CoV-2. Reference Ivan Fan-Ngai Hung, Kwok-Cheung Lung, Eugene Yuk-Keung Tso et al. Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial. Lancet. 2020 May 30;395(10238):1695-1704. Open reference URL https://web.pathway.md/studies/rec6YWTsCLGFZ4iR5 2/2