Hung
Trial question
What is the effect of the triple combination of interferon β-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
54.0% male
N = 127
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 β-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
Time to negativization of nasopharyngeal swab for severe acute respiratory syndrome coronavirus 2
7 days,
12 days,
12.0 days,
9.0 days,
6.0 days,
3.0 days,
0.0 days,
Combination
Control
Significant
decrease ▼
Significantly shorter time to negativization of nasopharyngeal swab for SARS-CoV-2 (7 days, vs. 12 days,; HR 0.22, 95% CI 0.09 to 0.53).
Secondary outcomes
Significantly shorter time to complete alleviation of symptoms (4 days vs. 8 days; HR 0.255, 95% CI 0.1 to 0.6).
Significantly shorter time to SOFA 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 negativization of nasopharyngeal swab 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.
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