IFN Beta-1b and Ribavirin for Covid-19

  • STATUS
    Recruiting
  • End date
    Aug 1, 2022
  • participants needed
    96
  • sponsor
    The University of Hong Kong
Updated on 24 January 2021
interferon
critical illness
SARS
antiviral drugs

Summary

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 -1b and ribavirin combination treatment for patients hospitalized for COVID-19 infection.

Description

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 -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 -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 -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 -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.

Details
Condition COVID19
Treatment Ribavirin, interferon beta-1b
Clinical Study IdentifierNCT04494399
SponsorThe University of Hong Kong
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Recruited subjects include all adult patients 18 years hospitalized for virologic confirmed SARS-CoV-2 infection
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
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

Inability to comprehend and to follow all required study procedures
Allergy or severe reactions to the study drugs
Patients taking medication that will potentially interact with l interferon beta-1b or ribavirin
Pregnant or lactation women
Patients with known history of severe depression
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
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
Have a history of alcohol or drug abuse in the last 5 years
Have any condition that the investigator believes may interfere with successful completion of the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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