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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

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 hos... Full description

Comment in: Lancet. 2020 May 30;395(10238):1670-1671. - PMID 32401712
Year of Publication: 2020
Contained in: Lancet (London, England) Vol. 395, No. 10238 (2020), p. 1695-1704
All journal articles: Search for all articles in this journal
Language: English
Contributors: Hung, Ivan Fan-Ngai | Author
Lung, Kwok-Cheung
Tso, Eugene Yuk-Keung
Liu, Raymond
Chung, Tom Wai-Hin
Chu, Man-Yee
Ng, Yuk-Yung
Lo, Jenny
Chan, Jacky
Tam, Anthony Raymond
Shum, Hoi-Ping
Chan, Veronica
Wu, Alan Ka-Lun
Sin, Kit-Man
Leung, Wai-Shing
Law, Wai-Lam
Lung, David Christopher
Sin, Simon
Yeung, Pauline
Yip, Cyril Chik-Yan
Zhang, Ricky Ruiqi
Fung, Agnes Yim-Fong
Yan, Erica Yuen-Wing
Leung, Kit-Hang
Ip, Jonathan Daniel
Chu, Allen Wing-Ho
Chan, Wan-Mui
Ng, Anthony Chin-Ki
Lee, Rodney
Fung, Kitty
Yeung, Alwin
Wu, Tak-Chiu
Chan, Johnny Wai-Man
Yan, Wing-Wah
Chan, Wai-Ming
Chan, Jasper Fuk-Woo
Lie, Albert Kwok-Wai
Tsang, Owen Tak-Yin
Cheng, Vincent Chi-Chung
Que, Tak-Lun
Lau, Chak-Sing
Chan, Kwok-Hung
To, Kelvin Kai-Wang
Yuen, Kwok-Yung
Full text access:
Electronic availability is being checked...
Links: Full Text (dx.doi.org)
Keywords: 145155-23-3
2494G1JF75
49717AWG6K
Clinical Trial, Phase II
Journal Article
Multicenter Study
O3J8G9O825
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
lopinavir-ritonavir drug combination
Additional Keywords: Adult
Betacoronavirus
Coronavirus Infections
Drug Combinations
Drug Therapy, Combination
Female
Hong Kong
Hospitalization
Humans
Interferon beta-1b
Lopinavir
Male
Middle Aged
Pandemics
Pneumonia, Viral
Ribavirin
Ritonavir
ISSN: 1474-547X
Note: Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Notes: Date Completed 02.06.2020
Date Revised 16.06.2020
published: Print-Electronic
CommentIn: Lancet. 2020 May 30;395(10238):1670-1671. - PMID 32401712
Citation Status MEDLINE
Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
PMID:
    32401715
Physical Description: Online-Ressource
ID (e.g. DOI, URN): 10.1016/S0140-6736(20)31042-4
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520 |a 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 
520 |a 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 
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700 1 |a Chan, Wan-Mui 
700 1 |a Ng, Anthony Chin-Ki 
700 1 |a Lee, Rodney 
700 1 |a Fung, Kitty 
700 1 |a Yeung, Alwin 
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700 1 |a Chan, Johnny Wai-Man 
700 1 |a Yan, Wing-Wah 
700 1 |a Chan, Wai-Ming 
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700 1 |a Lie, Albert Kwok-Wai 
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700 1 |a Cheng, Vincent Chi-Chung 
700 1 |a Que, Tak-Lun 
700 1 |a Lau, Chak-Sing 
700 1 |a Chan, Kwok-Hung 
700 1 |a To, Kelvin Kai-Wang 
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