<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04465695</url>
  </required_header>
  <id_info>
    <org_study_id>UW 20-463</org_study_id>
    <nct_id>NCT04465695</nct_id>
  </id_info>
  <brief_title>Dual Therapy With Interferon Beta-1b and Clofazimine for COVID-19</brief_title>
  <official_title>An Open-label Randomised Controlled Trial on Dual Therapy With Interferon Beta-1b and Clofazimine Combination, as Treatment for COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To conduct an open-label randomized controlled trial on a short course of interferon β-1b and&#xD;
      clofazimine combination treatment for patients hospitalized for COVID-19 infection. To assess&#xD;
      its safety and clinical efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The novel coronavirus (SARS-CoV-2), is a single-stranded RNA coronavirus. The virus was first&#xD;
      isolated from patients presented with pneumonia in Wuhan in December 2019.Sequences of the&#xD;
      Wuhan betacoronavirus show similarities to betacoronaviruses found in bats, sharing a common&#xD;
      ancestor with the 2003 SARS coronavirus (SARS-CoV) and the bat coronavirus HKU9-1, a virus&#xD;
      found in fruit bats. Similar to SARS-CoV, it is a member of Beta-CoV lineage B. Five genomes&#xD;
      of the novel coronavirus have been initially isolated and reported including&#xD;
      BetaCoV/Wuhan/IVDC-HB-01/2019, BetaCoV/Wuhan/IVDC-HB-04/2020, BetaCoV/Wuhan/IVDC-HB-05/2019,&#xD;
      BetaCoV/Wuhan/WIV04/2019, and BetaCoV/Wuhan/IPBCAMS-WH-01/2019 from the China CDC.&#xD;
&#xD;
      The SARS-CoV-2 has since spread from China to the rest of the world. As of 1 July 2020, more&#xD;
      than 10 million people been confirmed to have infected by SARS-CoV-2, resulting in more than&#xD;
      500,000 deaths. No specific antiviral treatment for the SARS-CoV-2 is currently available,&#xD;
      but existing medication could be repurposed.&#xD;
&#xD;
      Genetic sequencing demonstrated similarity of the SARS-CoV-2 to the SARS-CoV and MERS CoV.2&#xD;
      We expect patients infected with the SARS-CoV-2 will also present similarly with initial&#xD;
      upper respiratory tract symptoms including fever, cough, sputum, myalgia and shortness or&#xD;
      breath. More severe cases might complicate with pneumonia and required ventilatory or ECMO&#xD;
      support. According to our previous studies in 2003 on patients hospitalized for severe&#xD;
      SARS-CoV, the viral load peaked between day 7 from symptoms onset and coincided with clinical&#xD;
      deterioration of pneumonia and respiratory failure, with majority of the patients required&#xD;
      intensive care support. Higher viral load isolated from different human system also&#xD;
      correlated with worsened SARS manifestation and complications.&#xD;
&#xD;
      Previously, the investigators have demonstrated that interferon β-1b, commonly used in the&#xD;
      treatment of multiple sclerosis and lopinavir/ ritonavir, also demonstrated to improve the&#xD;
      outcome of MERS-CoV infection in a non-human primate model of common marmoset.7&#xD;
&#xD;
      More recently, the investigators have demonstrated that the triple combination of interferon&#xD;
      β-1b, lopinavir/ ritonavir and ribavirin was significantly more effective in alleviating&#xD;
      symptoms and respiratory SARS-CoV-2 viral load than lopinavir/ ritonavir with ribavirin or&#xD;
      lopinavir/ ritonavir alone, suggesting that interferon β-1b might be the most potent&#xD;
      antiviral among the three.&#xD;
&#xD;
      Another in-vitro study on an oral antimicrobial clofazimine for treatment of non-tuberculous&#xD;
      mycobacterium infection has been proven to reduce SARS-CoV-2 viral load.&#xD;
&#xD;
      Therefore, the investigators propose to perform a prospective open-label randomised&#xD;
      controlled trial among adult patients hospitalised after July 2020 for virologically&#xD;
      confirmed SARS-CoV-2 infection. Patients will be randomly assigned to one of the three&#xD;
      groups: group A: a 3-day course of 3 doses of subcutaneous injection of interferon β-1b 1mL&#xD;
      (0.5mg; 16 million IU) consecutively on day 1 to day 3 and oral clofazimine 100mg twice daily&#xD;
      on day 1, then 100mg daily for 2 days plus standard care, or group B: oral clofazimine 100mg&#xD;
      twice daily on day 1, then 100mg daily for 2 days plus standard care, or group C: standard&#xD;
      care alone (1:1:1).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Open-label randomised controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical alleviation of symptoms</measure>
    <time_frame>7 days</time_frame>
    <description>Time to complete alleviation of symptoms as defined by NEWS of 0 maintained for 24 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalisation</measure>
    <time_frame>14 days</time_frame>
    <description>Length of hospitalisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to negative viral load</measure>
    <time_frame>7 days</time_frame>
    <description>Time to negative nasopharyngeal swab, throat saliva and sputum viral load by RT-PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory changes</measure>
    <time_frame>7 days</time_frame>
    <description>Cytokine/ chemokine changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>One month mortality rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>30 days</time_frame>
    <description>Adverse events during and shortly after treatment</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">81</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>IFN beta-1b and clofazimine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 3-day course of 3 doses of subcutaneous injection of interferon β-1b 1mL (0.5mg; 16 million IU) consecutively on day 1 to day 3 and oral clofazimine 100mg twice daily on day 1, then 100mg daily for 2 days plus standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clofazimine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 3-day course of oral clofazimine 100mg twice daily on day 1, then 100mg daily for 2 days plus standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Interferon beta-1b</intervention_name>
    <description>Subcutaneous injection of interferon β-1b 1mL (0.5mg; 16 million IU) for 3 days</description>
    <arm_group_label>IFN beta-1b and clofazimine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clofazimine</intervention_name>
    <description>Oral 100mg twice daily on day 1, then 100mg daily for 2 days</description>
    <arm_group_label>Clofazimine</arm_group_label>
    <arm_group_label>IFN beta-1b and clofazimine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Recruited subjects include all adult patients 18 years or above hospitalized for&#xD;
             virologic confirmed SARS-CoV-2 infection.&#xD;
&#xD;
          2. All subjects give written informed consent. For patients who are critically ill,&#xD;
             requiring ICU, ventilation or confused, informed consent will be obtained from spouse,&#xD;
             next-of-kin or legal guardians.&#xD;
&#xD;
          3. Subjects must be available to complete the study and comply with study procedures.&#xD;
             Willingness to allow for serum samples to be stored beyond the study period, for&#xD;
             potential additional future testing to better characterize immune response&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to comprehend and to follow all required study procedures.&#xD;
&#xD;
          2. Allergy or severe reactions to the study drugs&#xD;
&#xD;
          3. Patients taking medication that will potentially interact with l interferon beta-1b or&#xD;
             clofazimine&#xD;
&#xD;
          4. Patients with known history of severe depression&#xD;
&#xD;
          5. Received an experimental agent (vaccine, drug, biologic, device, blood product, or&#xD;
             medication) within 1 month prior to recruitment in this study or expect to receive an&#xD;
             experimental agent during this study.&#xD;
&#xD;
          6. To participate in an unrelated trial during the current clinical trial. Nevertheless,&#xD;
             the patients have the right to withdraw from the current clinical trial to join&#xD;
             another clinical trial.&#xD;
&#xD;
          7. Have a history of alcohol or drug abuse in the last 5 years.&#xD;
&#xD;
          8. Have any condition that the investigator believes may interfere with successful&#xD;
             completion of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ivan FN Hung, MD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>HKU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ivan FN Hung, MD FRCP</last_name>
    <phone>22554049</phone>
    <email>ivanhung@hku.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kelvin KW To, MD FRCPath</last_name>
    <phone>22552584</phone>
    <email>kelvinto@hku.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The University of Hong Kong, Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <zip>852</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivan FN Hung, MD FRCP</last_name>
      <phone>852 22554049</phone>
      <email>ivanfn@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Hung IF, Lung KC, Tso EY, Liu R, Chung TW, Chu MY, Ng YY, Lo J, Chan J, Tam AR, Shum HP, Chan V, Wu AK, Sin KM, Leung WS, Law WL, Lung DC, Sin S, Yeung P, Yip CC, Zhang RR, Fung AY, Yan EY, Leung KH, Ip JD, Chu AW, Chan WM, Ng AC, Lee R, Fung K, Yeung A, Wu TC, Chan JW, Yan WW, Chan WM, Chan JF, Lie AK, Tsang OT, Cheng VC, Que TL, Lau CS, Chan KH, To KK, Yuen KY. Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial. Lancet. 2020 May 30;395(10238):1695-1704. doi: 10.1016/S0140-6736(20)31042-4. Epub 2020 May 10.</citation>
    <PMID>32401715</PMID>
  </reference>
  <reference>
    <citation>Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8.</citation>
    <PMID>32445440</PMID>
  </reference>
  <reference>
    <citation>Chu H, Chan JF, Wang Y, Yuen TT, Chai Y, Hou Y, Shuai H, Yang D, Hu B, Huang X, Zhang X, Cai JP, Zhou J, Yuan S, Kok KH, To KK, Chan IH, Zhang AJ, Sit KY, Au WK, Yuen KY. Comparative Replication and Immune Activation Profiles of SARS-CoV-2 and SARS-CoV in Human Lungs: An Ex Vivo Study With Implications for the Pathogenesis of COVID-19. Clin Infect Dis. 2020 Sep 12;71(6):1400-1409. doi: 10.1093/cid/ciaa410.</citation>
    <PMID>32270184</PMID>
  </reference>
  <reference>
    <citation>Chan JF, Yao Y, Yeung ML, Deng W, Bao L, Jia L, Li F, Xiao C, Gao H, Yu P, Cai JP, Chu H, Zhou J, Chen H, Qin C, Yuen KY. Treatment With Lopinavir/Ritonavir or Interferon-beta1b Improves Outcome of MERS-CoV Infection in a Nonhuman Primate Model of Common Marmoset. J Infect Dis. 2015 Dec 15;212(12):1904-13. doi: 10.1093/infdis/jiv392. Epub 2015 Jul 21.</citation>
    <PMID>26198719</PMID>
  </reference>
  <reference>
    <citation>Yuan S, Chan CC, Chik KK, Tsang JO, Liang R, Cao J, Tang K, Cai JP, Ye ZW, Yin F, To KK, Chu H, Jin DY, Hung IF, Yuen KY, Chan JF. Broad-Spectrum Host-Based Antivirals Targeting the Interferon and Lipogenesis Pathways as Potential Treatment Options for the Pandemic Coronavirus Disease 2019 (COVID-19). Viruses. 2020 Jun 10;12(6):628. doi: 10.3390/v12060628.</citation>
    <PMID>32532085</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Ivan FN Hung MD</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>hospitalised</keyword>
  <keyword>IFN beta-1b</keyword>
  <keyword>clofazimine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-beta</mesh_term>
    <mesh_term>Clofazimine</mesh_term>
    <mesh_term>Interferon beta-1b</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>To share anonymised participant data</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Within 12 months of study published</ipd_time_frame>
    <ipd_access_criteria>To be approved by the HKU/ IRB clinical trial study panel of valid research purpose</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04465695
org study id: UW 20-463
nct id: NCT04465695
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To conduct an open-label randomized controlled trial on a short course of interferon β-1b and
      clofazimine combination treatment for patients hospitalized for COVID-19 infection. To assess
      its safety and clinical efficacy.
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 HKU9-1, 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 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.

      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 β-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.7

      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.

      Another in-vitro study on an oral antimicrobial clofazimine for treatment of non-tuberculous
      mycobacterium infection has been proven to reduce SARS-CoV-2 viral load.

      Therefore, the investigators propose to perform a prospective open-label randomised
      controlled trial among adult patients hospitalised after July 2020 for virologically
      confirmed SARS-CoV-2 infection. Patients will be randomly assigned to one of the three
      groups: group A: a 3-day course of 3 doses of subcutaneous injection of interferon β-1b 1mL
      (0.5mg; 16 million IU) consecutively on day 1 to day 3 and oral clofazimine 100mg twice daily
      on day 1, then 100mg daily for 2 days plus standard care, or group B: oral clofazimine 100mg
      twice daily on day 1, then 100mg daily for 2 days plus standard care, or group C: standard
      care alone (1:1:1).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open-label randomised controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical alleviation of symptoms
time frame: 7 days
description: Time to complete alleviation of symptoms as defined by NEWS of 0 maintained for 24 hours
measure: Hospitalisation
time frame: 14 days
description: Length of hospitalisation
measure: Time to negative viral load
time frame: 7 days
description: Time to negative nasopharyngeal swab, throat saliva and sputum viral load by RT-PCR
measure: Inflammatory changes
time frame: 7 days
description: Cytokine/ chemokine changes
measure: Mortality
time frame: 30 days
description: One month mortality rate
measure: Adverse events
time frame: 30 days
description: Adverse events during and shortly after treatment
arm group label: IFN beta-1b and clofazimine
arm group type: Experimental
description: A 3-day course of 3 doses of subcutaneous injection of interferon β-1b 1mL (0.5mg; 16 million IU) consecutively on day 1 to day 3 and oral clofazimine 100mg twice daily on day 1, then 100mg daily for 2 days plus standard care
arm group label: Clofazimine
arm group type: Active Comparator
description: A 3-day course of oral clofazimine 100mg twice daily on day 1, then 100mg daily for 2 days plus standard care
arm group label: Control
arm group type: No Intervention
description: Standard care alone
intervention type: Drug
intervention name: Interferon beta-1b
description: Subcutaneous injection of interferon β-1b 1mL (0.5mg; 16 million IU) for 3 days
arm group label: IFN beta-1b and clofazimine
intervention type: Drug
intervention name: Clofazimine
description: Oral 100mg twice daily on day 1, then 100mg daily for 2 days
arm group label: Clofazimine
arm group label: IFN beta-1b and clofazimine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ivan FN Hung, MD FRCP
role: Principal Investigator
affiliation: HKU
last name: Ivan FN Hung, MD FRCP
phone: 22554049
email: ivanhung@hku.hk
last name: Kelvin KW To, MD FRCPath
phone: 22552584
email: kelvinto@hku.hk
facility: 
status: Recruiting
contact: 
country: China
citation: Hung IF, Lung KC, Tso EY, Liu R, Chung TW, Chu MY, Ng YY, Lo J, Chan J, Tam AR, Shum HP, Chan V, Wu AK, Sin KM, Leung WS, Law WL, Lung DC, Sin S, Yeung P, Yip CC, Zhang RR, Fung AY, Yan EY, Leung KH, Ip JD, Chu AW, Chan WM, Ng AC, Lee R, Fung K, Yeung A, Wu TC, Chan JW, Yan WW, Chan WM, Chan JF, Lie AK, Tsang OT, Cheng VC, Que TL, Lau CS, Chan KH, To KK, Yuen KY. Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial. Lancet. 2020 May 30;395(10238):1695-1704. doi: 10.1016/S0140-6736(20)31042-4. Epub 2020 May 10.
PMID: 32401715
citation: Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8.
PMID: 32445440
citation: Chu H, Chan JF, Wang Y, Yuen TT, Chai Y, Hou Y, Shuai H, Yang D, Hu B, Huang X, Zhang X, Cai JP, Zhou J, Yuan S, Kok KH, To KK, Chan IH, Zhang AJ, Sit KY, Au WK, Yuen KY. Comparative Replication and Immune Activation Profiles of SARS-CoV-2 and SARS-CoV in Human Lungs: An Ex Vivo Study With Implications for the Pathogenesis of COVID-19. Clin Infect Dis. 2020 Sep 12;71(6):1400-1409. doi: 10.1093/cid/ciaa410.
PMID: 32270184
citation: Chan JF, Yao Y, Yeung ML, Deng W, Bao L, Jia L, Li F, Xiao C, Gao H, Yu P, Cai JP, Chu H, Zhou J, Chen H, Qin C, Yuen KY. Treatment With Lopinavir/Ritonavir or Interferon-beta1b Improves Outcome of MERS-CoV Infection in a Nonhuman Primate Model of Common Marmoset. J Infect Dis. 2015 Dec 15;212(12):1904-13. doi: 10.1093/infdis/jiv392. Epub 2015 Jul 21.
PMID: 26198719
citation: Yuan S, Chan CC, Chik KK, Tsang JO, Liang R, Cao J, Tang K, Cai JP, Ye ZW, Yin F, To KK, Chu H, Jin DY, Hung IF, Yuen KY, Chan JF. Broad-Spectrum Host-Based Antivirals Targeting the Interferon and Lipogenesis Pathways as Potential Treatment Options for the Pandemic Coronavirus Disease 2019 (COVID-19). Viruses. 2020 Jun 10;12(6):628. doi: 10.3390/v12060628.
PMID: 32532085
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Ivan FN Hung MD
investigator title: Clinical Professor
mesh term: COVID-19
mesh term: Interferons
mesh term: Interferon-beta
mesh term: Clofazimine
mesh term: Interferon beta-1b
sharing ipd: Yes
ipd description: To share anonymised participant data
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Within 12 months of study published
ipd access criteria: To be approved by the HKU/ IRB clinical trial study panel of valid research purpose