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.
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.
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