Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647695
Status:
UNKNOWN
Last Update Posted:
2020-12-10
First Post:
2020-11-27
Brief Title:
IFN-beta 1b and Remdesivir for COVID19
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
An Open-label Randomized Controlled Trial on Interferon β-1b and Remdesivir Combination Versus Remdesivir as Treatment for COVID-19 Infection
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 5-day combination of interferon β-1b and remdesivir will expedite the recovery suppress the viral load and shorten hospitalisation in patients with SARS-CoV-2 infection compare to the control arm
Detailed Description:
Introduction 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 and the bat coronavirus HKU 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 BetaCoVWuhanIVDC-HB-012019 BetaCoVWuhanIVDC-HB-042020 BetaCoVWuhanIVDC-HB-052019 BetaCoVWuhanWIV042019 and BetaCoVWuhanIPBCAMS-WH-012019 from the China CDC
The SARS-CoV-2 has since spread from China to the rest of the world As of 20 November 2020 more than 50 million people been confirmed to have infected by SARS-CoV-2 resulting in more than 1000000 deaths Remdesivir has been shown to clinically effective in severe Covid-19 patients but virological data is lacking FDA has approved the use of remdesivir for the treatment of severe Covid-19 infection Apart from remdesivir 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 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-beta1b 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 more recent open-label randomized controlled trial by our team has proven that interferon beta-1b in combination with lopinavir ritonavir and ribavirin reduced the SARS-CoV-2 viral load in the respiratory tract and resulted in faster alleviation of clinical symptoms when compared to lopinavir ritonavir alone or with ribavirin suggesting that interferon beta-1b was likely to be the backbone of this triple therapy
Therefore the investigators propose to conduct an open-label randomized controlled trial on interferon beta-1b and remdesivir combination versus remdesivir as treatment for patients hospitalized for COVID-19 infection
Patients will be randomly assigned to one of the two groups Group A a 5-day course of subcutaneous injection of interferon β-1b 2mL 16 million IU consecutively and IV remdesivir 200mg loading on day 1 followed by remdesivir 100mg daily on day 2 to day 5 or Group B a 5-day course of IV remdesivir 200mg loading on day 1 followed by remdesivir 100mg daily on day 2 to day 5 11
The SARS-CoV-2 has since spread from China to the rest of the world As of 20 November 2020 more than 50 million people been confirmed to have infected by SARS-CoV-2 resulting in more than 1000000 deaths Remdesivir has been shown to clinically effective in severe Covid-19 patients but virological data is lacking FDA has approved the use of remdesivir for the treatment of severe Covid-19 infection Apart from remdesivir 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 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-beta1b 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 more recent open-label randomized controlled trial by our team has proven that interferon beta-1b in combination with lopinavir ritonavir and ribavirin reduced the SARS-CoV-2 viral load in the respiratory tract and resulted in faster alleviation of clinical symptoms when compared to lopinavir ritonavir alone or with ribavirin suggesting that interferon beta-1b was likely to be the backbone of this triple therapy
Therefore the investigators propose to conduct an open-label randomized controlled trial on interferon beta-1b and remdesivir combination versus remdesivir as treatment for patients hospitalized for COVID-19 infection
Patients will be randomly assigned to one of the two groups Group A a 5-day course of subcutaneous injection of interferon β-1b 2mL 16 million IU consecutively and IV remdesivir 200mg loading on day 1 followed by remdesivir 100mg daily on day 2 to day 5 or Group B a 5-day course of IV remdesivir 200mg loading on day 1 followed by remdesivir 100mg daily on day 2 to day 5 11
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None