Covid19 Clinical Trial
Official title:
An Open-label Randomised Controlled Trial on IFN Beta-1b and Ribavirin Combination, as Treatment for Covid-19 Infection
As of 1 July 2020, more than 10 million people been confirmed to have infected by SARS-CoV-2,
resulting in more than 500,000 deaths. No specific antiviral treatment for the SARS-CoV-2 is
currently available, but existing medication could be repurposed.
The investigators therefore propose to conduct an open-label randomized controlled trial on a
short course of interferon β-1b and ribavirin combination treatment for patients hospitalized
for COVID-19 infection.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | August 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Recruited subjects include all adult patients =18 years hospitalized for virologic confirmed SARS-CoV-2 infection. 2. All subjects give written informed consent. For patients who are critically ill, requiring ICU, ventilation or confused, informed consent will be obtained from spouse, next-of-kin or legal guardians. 3. Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response. Exclusion Criteria: 1. Inability to comprehend and to follow all required study procedures. 2. Allergy or severe reactions to the study drugs 3. Patients taking medication that will potentially interact with l interferon beta-1b or ribavirin 4. Pregnant or lactation women 5. Patients with known history of severe depression 6. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to recruitment in this study or expect to receive an experimental agent during this study. 7. To participate in an unrelated trial during the current clinical trial. Nevertheless, the patients have the right to withdraw from the current clinical trial to join another clinical trial. 8. Have a history of alcohol or drug abuse in the last 5 years. 9. Have any condition that the investigator believes may interfere with successful completion of the study. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong, Queen Mary Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Hospital Authority, Hong Kong |
Hong Kong,
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Chan JF, Yao Y, Yeung ML, Deng W, Bao L, Jia L, Li F, Xiao C, Gao H, Yu P, Cai JP, Chu H, Zhou J, Chen H, Qin C, Yuen KY. Treatment With Lopinavir/Ritonavir or Interferon-ß1b Improves Outcome of MERS-CoV Infection in a Nonhuman Primate Model of Common Marmoset. J Infect Dis. 2015 Dec 15;212(12):1904-13. doi: 10.1093/infdis/jiv392. Epub 2015 Jul 21. — View Citation
Chu H, Chan JF, Wang Y, Yuen TT, Chai Y, Hou Y, Shuai H, Yang D, Hu B, Huang X, Zhang X, Cai JP, Zhou J, Yuan S, Kok KH, To KK, Chan IH, Zhang AJ, Sit KY, Au WK, Yuen KY. Comparative replication and immune activation profiles of SARS-CoV-2 and SARS-CoV in human lungs: an ex vivo study with implications for the pathogenesis of COVID-19. Clin Infect Dis. 2020 Apr 9. pii: ciaa410. doi: 10.1093/cid/ciaa410. [Epub ahead of print] — View Citation
Hung IF, Lung KC, Tso EY, Liu R, Chung TW, Chu MY, Ng YY, Lo J, Chan J, Tam AR, Shum HP, Chan V, Wu AK, Sin KM, Leung WS, Law WL, Lung DC, Sin S, Yeung P, Yip CC, Zhang RR, Fung AY, Yan EY, Leung KH, Ip JD, Chu AW, Chan WM, Ng AC, Lee R, Fung K, Yeung A, Wu TC, Chan JW, Yan WW, Chan WM, Chan JF, Lie AK, Tsang OT, Cheng VC, Que TL, Lau CS, Chan KH, To KK, Yuen KY. 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. doi: 10.1016/S0140-6736(20)31042-4. Epub 2020 May 10. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical symptoms alleviation | Time to complete alleviation of symptoms as defined by NEWS2 of 0 maintained for 24 hours | 7 days | |
Secondary | Hospitalisation | Length of hospitalisation | 14 days | |
Secondary | Time to negative viral load | Time to negative nasopharyngeal swab and throat saliva viral load by RT-PCR | 7 days | |
Secondary | Inflammatory changes | Cytokine/ chemokine changes | 7 days | |
Secondary | Mortality | One month mortality rate | 30 days | |
Secondary | Adverse events and serious adverse events | Adverse events and serious adverse events within 30 days of treatment | 30 days |
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