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Trial record 5 of 19 for:    ibudilast

Efficacy, Safety, Tolerability, and Biomarkers of MN-166 (Ibudilast) in Patients Hospitalized With COVID-19 and at Risk for ARDS

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ClinicalTrials.gov Identifier: NCT04429555
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
MediciNova

Tracking Information
First Submitted Date  ICMJE June 9, 2020
First Posted Date  ICMJE June 12, 2020
Last Update Posted Date February 23, 2021
Actual Study Start Date  ICMJE January 11, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
  • Proportion of subjects free from respiratory failure [ Time Frame: 7 days ]
    Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirements (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 7
  • Mean change from baseline in clinical status using the NIAID 8-point ordinal scale at Day 7 [ Time Frame: 7 days ]
    Mean change from baseline in clinical status based on the NIAID 8-point scale (1= death, 8= not hospitalized, no limitations on activities) at Day 7. A higher score indicates improvement.
  • Percentage of patients with improvement in clinical status [ Time Frame: 7 days ]
    Percentage of patients with at least a one-point improvement in clinical status using the NIAID 8-point ordinal scale (1= death, 8= not hospitalized, no limitations on activities) at Day 7. A higher score indicates improvement.
  • Change in cytokine levels from baseline [ Time Frame: 7 days ]
    Mean change from baseline (baseline = 1-fold; any value above 1.0 indicates elevation in cytokine levels; any value below 1.0 indicates reduction in cytokine levels) in migration inhibitory factor (MIF), (interleukin 1-beta (IL-1β), interleukin 6 (IL-6), tumor necrosis factor (TNF-α), and C-reactive protein (CRP) at Day 7.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
  • Adverse event Incidence, severity, relationship to study drug, and study discontinuations [ Time Frame: Days 7, 14 ]
    Incidence, frequency, and severity of adverse events at Day 7 and Day 14
  • Changes in laboratory values from baseline [ Time Frame: 7 days ]
    Incidence of out-of-normal-range values and markedly abnormal change from baseline in laboratory safety test variables by treatment group.
  • Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirement (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 14 [ Time Frame: 14 days ]
    Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirement (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 14
  • Mean change from baseline in clinical status [ Time Frame: Days 14, 28 ]
    Mean change from baseline in clinical status using the NIAID 8-point ordinal scale at Day 14 and Day 28
  • Incidence of mechanical ventilation or intubation [ Time Frame: Days 7, 14 ]
    Proportion of subjects receiving mechanical ventilation or intubation.
  • Intensive care unit admission [ Time Frame: 7 days ]
    Proportion of subjects requiring submission to the intensive care unit
  • Plasma concentrations of Ibudilast [ Time Frame: 7 days ]
    Blood sample collection to determine plasma concentrations of ibudilast.
  • All cause mortality [ Time Frame: Days 7, 14, 28 ]
    Number of deaths from any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, Tolerability, and Biomarkers of MN-166 (Ibudilast) in Patients Hospitalized With COVID-19 and at Risk for ARDS
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, Tolerability, Biomarkers and Pharmacokinetics of Ibudilast (MN-166) in COVID-19 Subjects at Risk for Developing Acute Respiratory Distress Syndrome
Brief Summary The study aims to evaluate MN-166 (ibudilast) in patients with COVID-19 who are at risk of developing acute respiratory distress syndrome. Subjects will be screened, randomly assigned to MN-166 or placebo groups, receive study drug on Days 1-7, and followed up on Day 14 and Day 28.
Detailed Description

This is a randomized (1:1) double-blind, placebo-controlled, parallel-group study of ibudilast in hospitalized COVID-19 subjects at risk for developing ARDS receiving standard of care including anticoagulation. The study will consist of a Screening Phase followed by a Treatment and Follow-up Phase. Following the Screening Phase, if the subject meets eligibility criteria, subject will be administered treatment with MN-166 (ibudilast) or placebo. Subjects will receive ibudilast 100 mg/d (50 mg b.i.d) or placebo every day for 7 days. Upon completion of the 7-day Treatment Phase, subject will be followed-up at Day 14 and at Day 28 post baseline. Subjects discharged prior to Day 7 will be given the remainder of their study medication to be taken at home twice daily and will be given a pulse oximeter to measure their oxygen levels once daily until Day 14.

The following screening assessments will be performed upon signing the ICF: inclusion/exclusion criteria review, physical exam, assess vital signs and O2 use, clinical status using the National Institute of Allergy and Infectious Diseases scale, 12-lead ECG, draw blood for plasma biomarkers that include: migration inhibitory factor (MIF), (interleukin 1-beta (IL-1β), interleukin 6 (IL-6), tumor necrosis factor (TNFα), and C-reactive protein (CRP). A complete blood count (CBC), comprehensive metabolic panel (CMP), D-dimer and coagulation tests will also be drawn. A serum pregnancy test will be done in pre-menopausal females. Prior concomitant medications taken within the last 7 days prior to study drug administration will be recorded.

During the Treatment Phase, hospitalized subjects will be treated with MN-166 or placebo for a 7-day period. During the Treatment Phase, subjects will undergo study-related procedures including physical exam, ECG, Oxygen use assessment, biomarkers and pharmacokinetic samples draw, CBC, CMP, D-dimer blood collection, clinical assessment using the NIAID scale, and information on adverse events and concomitant medications will be recorded.

On Study Day 14, conduct physical examination, clinical status, vital signs and oxygen use, ECG, CBC, CMP, D-dimer, and coagulation tests, biomarkers, AE and concomitant medications review. On Day 28, subject's clinical status and survival status will be recorded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled, parallel-group study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia, Viral
Intervention  ICMJE
  • Drug: Ibudilast
    Ibudilast orally administered, 50 mg twice daily for 7 days.
    Other Name: MN-166
  • Drug: Placebo
    Placebo orally administered, 50 mg twice daily for 7 days.
Study Arms  ICMJE
  • Experimental: MN-166 (ibudilast)
    MN-166 capsules, 50 mg twice daily, for 7 days.
    Intervention: Drug: Ibudilast
  • Placebo Comparator: Placebo
    Placebo capsules, 50 mg twice daily, for 7 days.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • SARS-CoV-2 infection confirmed with WHO criteria (including a positive PCR of any specimen, e.g., blood, respiratory, stool, urine, or any other body fluid)
  • Chest imaging (radiograph, CT scan or lung ultrasound) with abnormalities consistent with COVID-19 pneumonia
  • SpO2 ≤ 92% on room air (RA), RR ≥24 breaths per min on RA, and/or requirement for supplemental oxygen
  • At least 1 risk factor which may put patient at higher risk for more severe illness from COVID-19: Age > 65, underlying serious heart disease, chronic lung disease, moderate to severe asthma, body mass index of ≥ 40 or diabetes

Exclusion Criteria:

  • Suspected active bacterial, fungal, viral, or other cause of respiratory failure other than COVID-19
  • Subject is already intubated and on ventilator support
  • Known or suspected immunosuppression with immunosuppressant medications or chemotherapeutic agents
  • Subject is on dialysis
  • On home ventilator support or continuous domiciliary O2 therapy for baseline lung disease
  • Active tuberculosis (TB) infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kazuko Matsuda, MD, PhD, MPH 858-373-1500 matsuda@medicinova.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04429555
Other Study ID Numbers  ICMJE MN-166-COVID-19-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MediciNova
Study Sponsor  ICMJE MediciNova
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kazuko Matsuda, MD PhD MPH Medicinova Inc
PRS Account MediciNova
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP