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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
Sponsor:
Collaborator:
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
The University of Hong Kong

Brief 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 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

Detailed 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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open label randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Drug: Ribavirin
5-day course of oral ribavirin 400mg twice daily

No Intervention: Control group
Standard care alone



Primary Outcome Measures :
  1. Clinical symptoms alleviation [ Time Frame: 7 days ]
    Time to complete alleviation of symptoms as defined by NEWS2 of 0 maintained for 24 hours


Secondary Outcome Measures :
  1. Hospitalisation [ Time Frame: 14 days ]
    Length of hospitalisation

  2. Time to negative viral load [ Time Frame: 7 days ]
    Time to negative nasopharyngeal swab and throat saliva viral load by RT-PCR

  3. Inflammatory changes [ Time Frame: 7 days ]
    Cytokine/ chemokine changes

  4. Mortality [ Time Frame: 30 days ]
    One month mortality rate

  5. Adverse events and serious adverse events [ Time Frame: 30 days ]
    Adverse events and serious adverse events within 30 days of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Recruited subjects include all adult patients ≥18 years hospitalized for virologic confirmed SARS-CoV-2 infection.
  2. 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.
  3. 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:

  1. Inability to comprehend and to follow all required study procedures.
  2. Allergy or severe reactions to the study drugs
  3. Patients taking medication that will potentially interact with l interferon beta-1b or ribavirin
  4. Pregnant or lactation women
  5. Patients with known history of severe depression
  6. 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.
  7. 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.
  8. Have a history of alcohol or drug abuse in the last 5 years.
  9. Have any condition that the investigator believes may interfere with successful completion of the study.

Information from the National Library of Medicine

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


Contacts
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Contact: Ivan FN Hung, MD FRCP 22554049 ivanhung@hku.hk
Contact: Kelvin KW To, MD FRCPath 22552584 kelvinto@hku.hk

Locations
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Hong Kong
The University of Hong Kong, Queen Mary Hospital Recruiting
Hong Kong, Hong Kong, 852
Contact: Ivan FN Hung, MD FRCP    22554049    ivanhung@hku.hk   
Contact: Kelvin KW To, MD FRCPath       kelvinto@hku.hk   
Principal Investigator: Ivan FN Hung, MD FRCP         
Sub-Investigator: Kelvin To, MD MRCP         
Sponsors and Collaborators
The University of Hong Kong
Hospital Authority, Hong Kong
Investigators
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Principal Investigator: Ivan FN Hung, MD FRCP The University of Hong Kong
Publications:

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04494399    
Other Study ID Numbers: UW 20-513
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong:
interferon beta-1b
ribavirin
hospitalised
patients
Additional relevant MeSH terms:
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Interferons
Ribavirin
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic