Double Therapy With IFN-beta 1b and Hydroxychloroquine
Status:
Completed
Trial end date:
2020-07-07
Target enrollment:
Participant gender:
Summary
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. Sequences of the
Wuhan betacoronavirus show similarities to betacoronaviruses found in bats, sharing a common
ancestor with the 2003 SARS coronavirus (SARS-CoV) and the bat coronavirus HKU9, a virus
found in fruit bats. Similar to SARS-CoV, it is a member of Beta-CoV lineage B. Five genomes
of the novel coronavirus have been initially isolated and reported including
BetaCoV/Wuhan/IVDC-HB-01/2019, BetaCoV/Wuhan/IVDC-HB-04/2020, BetaCoV/Wuhan/IVDC-HB-05/2019,
BetaCoV/Wuhan/WIV04/2019, and BetaCoV/Wuhan/IPBCAMS-WH-01/2019 from the China CDC.
The SARS-CoV-2 has since spread from China to the rest of the world. As of 5 April 2020, more
than 1.05 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.
Genetic sequencing demonstrated similarity of the SARS-CoV-2 to the SARS-CoV and MERS CoV.2
We expect patients infected with the SARS-CoV-2 will also present similarly with initial
upper respiratory tract symptoms including fever, cough, sputum, myalgia and shortness or
breath. More severe cases might complicate with pneumonia and required ventilatory or ECMO
support. According to our previous studies in 2003 on patients hospitalized for severe
SARS-CoV, the viral load peaked between day 7 from symptoms onset and coincided with clinical
deterioration of pneumonia and respiratory failure, with majority of the patients required
intensive care support. Higher viral load isolated from different human system also
correlated with worsened SARS manifestation and complications.
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.
A non-randomized trial has also suggested that a combination of hydroxychloroquine and
azithromycin might be effective in suppressing SARS-CoV-2 viral load in patients, despite
in-vitro activity was only found in hydroxychloroquine.
Therefore, the investigators propose to conduct an open-label randomized controlled trial on
a short course of interferon β-1b and hydroxychloroquine combination treatment for patients
hospitalized for COVID-19 infection.