IFN Beta-1b and Ribavirin for Covid-19
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|ClinicalTrials.gov Identifier: NCT04494399|
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : July 31, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Interferon beta-1b Drug: Ribavirin||Phase 2|
The novel coronavirus (SARS-CoV-2), is a single-stranded RNA coronavirus. The virus was first isolated from patients presented with pneumonia in Wuhan in December 2019. It is believed that the virus first emerged from patients working in the Wuhan Seafood Market which also sold contaminated wild animals, consumed as a local delicacy. Sequences of the Wuhan betacoronavirus show similarities to betacoronaviruses found in bats, sharing a common ancestor with the 2003 SARS coronavirus (SARS-CoV).
The SARS-CoV-2 has since spread from China to the rest of the world. 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.
Previously, the investigators have demonstrated that interferon beta-1b, commonly used in the treatment of multiple sclerosis and lopinavir/ ritonavir, also demonstrated to improve the outcome of MERS-CoV infection in a non-human primate model of common marmoset. More recently, the investigators have demonstrated that the triple combination of interferon β-1b, lopinavir/ ritonavir and ribavirin was significantly more effective in alleviating symptoms and respiratory SARS-CoV-2 viral load than lopinavir/ ritonavir with ribavirin or lopinavir/ ritonavir alone, suggesting that interferon β-1b might be the most potent antiviral among the three and lopinavir/ ritonavir is associated with relatively more side effects including diarrhoea and cardiac arrhythmia.
Therefore, the investigators 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.
Patients will be randomly assigned to one of the two groups: the Treatment group: a 5-day course of subcutaneous injection of interferon β-1b 2mL (16 million IU) consecutively and oral ribavirin 400mg twice daily, or the Control group: supportive care alone (1:1).
For patients randomized to the Control group, if the nasopharyngeal swab (NPS) or throat saliva (TS) viral load is still detectable on day 3, the patients will receive the same treatment as in the Treatment group from day 4 to day 8.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||open label randomised controlled trial|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Randomised Controlled Trial on IFN Beta-1b and Ribavirin Combination, as Treatment for Covid-19 Infection|
|Actual Study Start Date :||July 29, 2020|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||August 1, 2022|
Active Comparator: Treatment group
5-day course of daily subcutaneous injection of interferon β-1b 2mL (16 million IU) consecutively and oral ribavirin 400mg twice daily plus standard care
Drug: Interferon beta-1b
5-day course of daily subcutaneous injection of interferon β-1b 16 million IU
5-day course of oral ribavirin 400mg twice daily
No Intervention: Control group
Standard care alone
- Clinical symptoms alleviation [ Time Frame: 7 days ]Time to complete alleviation of symptoms as defined by NEWS2 of 0 maintained for 24 hours
- Hospitalisation [ Time Frame: 14 days ]Length of hospitalisation
- Time to negative viral load [ Time Frame: 7 days ]Time to negative nasopharyngeal swab and throat saliva viral load by RT-PCR
- Inflammatory changes [ Time Frame: 7 days ]Cytokine/ chemokine changes
- Mortality [ Time Frame: 30 days ]One month mortality rate
- Adverse events and serious adverse events [ Time Frame: 30 days ]Adverse events and serious adverse events within 30 days of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04494399
|Contact: Ivan FN Hung, MD FRCPemail@example.com|
|Contact: Kelvin KW To, MD FRCPathfirstname.lastname@example.org|
|The University of Hong Kong, Queen Mary Hospital||Recruiting|
|Hong Kong, Hong Kong, 852|
|Contact: Ivan FN Hung, MD FRCP 22554049 email@example.com|
|Contact: Kelvin KW To, MD FRCPath firstname.lastname@example.org|
|Principal Investigator: Ivan FN Hung, MD FRCP|
|Sub-Investigator: Kelvin To, MD MRCP|
|Principal Investigator:||Ivan FN Hung, MD FRCP||The University of Hong Kong|