Dual Therapy With Interferon Beta-1b and Clofazimine for COVID-19

NCT04465695 | Unknown Phase 2 DMC

• 1 other identifier: UW 20-463
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19; hospitalised; IFN beta-1b; clofazimine

Outcome Measures

Primary Outcomes (1)

• Clinical alleviation of symptoms

  Time to complete alleviation of symptoms as defined by NEWS of 0 maintained for 24 hours

  7 days

Secondary Outcomes (5)

• Hospitalisation

  14 days

• Time to negative viral load

  7 days

• Inflammatory changes

  7 days

• Mortality

  30 days

• Adverse events

  30 days

Study Arms (3)

IFN beta-1b and clofazimine

EXPERIMENTAL

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

Drug: Interferon beta-1b; Drug: Clofazimine

Clofazimine

ACTIVE COMPARATOR

A 3-day course of oral clofazimine 100mg twice daily on day 1, then 100mg daily for 2 days plus standard care

Drug: Clofazimine

Control

NO INTERVENTION

Standard care alone

Interventions

Interferon beta-1b DRUG

Subcutaneous injection of interferon β-1b 1mL (0.5mg; 16 million IU) for 3 days

IFN beta-1b and clofazimine

Clofazimine DRUG

Oral 100mg twice daily on day 1, then 100mg daily for 2 days

Clofazimine; IFN beta-1b and clofazimine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recruited subjects include all adult patients 18 years or above 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

You may not qualify if:

• 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 clofazimine
• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong, 852, China

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Interferon beta-1b; Clofazimine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phenazines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ivan FN Hung, MD FRCP

  HKU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan FN Hung, MD FRCP

CONTACT

22554049; ivanhung@hku.hk

Kelvin KW To, MD FRCPath

CONTACT

22552584; kelvinto@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Open-label randomised controlled trial

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 10, 2020
• Study Start: July 14, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 12 months of study published
• Access Criteria: To be approved by the HKU/ IRB clinical trial study panel of valid research purpose

Locations

CN (1)