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
Date
2020Author
Fan-Ngai Hung, Ivan
Lung, Kwok-Cheung
Yuk-Keung Tso, Eugene
Liu, Raymond
Wai-Hin Chung, Tom
Chu, Man-Yee
Ng, Yuk-Yung
Lo, Jenny
Chan, Jacky
Raymond Tam, Anthony
Shum, Hoi-Ping
Chan, Veronica
Ka-Lun Wu, Alan
Sin, Kit-Man
Leung, Wai-Shing
Law, Wai-Lam
Lung, David Christopher
Yeung, Pauline
Chik-Yan Yip, Cyril
Ruiqi Zhang, Ricky
Yim-Fong Fung, Agnes
Yuen-Wing Yan, Erica
Leung, Kit-Hang
Ip, Jonathan Daniel
Wing-Ho Chu, Allen
Chan, Wan-Mui
Chin-Ki Ng, Anthony
Lee, Rodney
Fung, Kitty
Yeung, Alwin
Wu, Tak-Chiu
Wai-Man Chan, Johnny
Yan, Wing-Wah
Chan, Wai-Ming
Fuk-Woo Chan, Jasper
Kwok-Wai Lie, Albert
Tak-Yin Tsang, Owen
Chi-Chung Cheng, Vincent
Que, Tak-Lun
Lau, Chak-Sing
Chan, Kwok-Hung
Kai-Wang To, Kelvin
Yuen, Kwok-Yung
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Abstract
Background Effective antiviral therapy is important for tackling the coronavirus disease 2019 (COVID-19) pandemic.
We assessed the efficacy and safety of combined interferon beta-1b, lopinavir–ritonavir, and ribavirin for treating
patients with COVID-19.
Methods This was a multicentre, prospective, open-label, randomised, phase 2 trial in adults with COVID-19 who
were admitted to six hospitals in Hong Kong. Patients were randomly assigned (2:1) to a 14-day combination of
lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin 400 mg every 12 h, and three doses of 8 million international
units of interferon beta-1b on alternate days (combination group) or to 14 days of lopinavir 400 mg and ritonavir
100 mg every 12 h (control group). The primary endpoint was the time to providing a nasopharyngeal swab negative
for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population. The
study is registered with ClinicalTrials.gov, NCT04276688.
Findings Between Feb 10 and March 20, 2020, 127 patients were recruited; 86 were randomly assigned to the
combination group and 41 were assigned to the control group. The median number of days from symptom onset to
start of study treatment was 5 days (IQR 3–7). The combination group had a significantly shorter median time from
start of study treatment to negative nasopharyngeal swab (7 days [IQR 5–11]) than the control group (12 days [8–15];
hazard ratio 4·37 [95% CI 1·86–10·24], p=0·0010). Adverse events included self-limited nausea and diarrhoea with no
difference between the two groups. One patient in the control group discontinued lopinavir–ritonavir because of
biochemical hepatitis. No patients died during the study.
Interpretation Early triple antiviral therapy was safe and superior to lopinavir–ritonavir alone in alleviating symptoms
and shortening the duration of viral shedding and hospital stay in patients with mild to moderate COVID-19. Future
clinical study of a double antiviral therapy with interferon beta-1b as a backbone is warranted.
Link to resource
https://doi.org/10.1016/Collections
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