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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 : Not yet recruiting
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
MediciNova

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Viral Drug: Ibudilast Drug: Placebo Phase 2

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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: 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
Estimated Study Start Date : July 31, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 1, 2021


Arm Intervention/treatment
Experimental: MN-166 (ibudilast)
MN-166 capsules, 50 mg twice daily, for 7 days.
Drug: Ibudilast
Ibudilast orally administered, 50 mg twice daily for 7 days.
Other Name: MN-166

Placebo Comparator: Placebo
Placebo capsules, 50 mg twice daily, for 7 days.
Drug: Placebo
Placebo orally administered, 50 mg twice daily for 7 days.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. Incidence of mechanical ventilation or intubation [ Time Frame: Days 7, 14 ]
    Proportion of subjects receiving mechanical ventilation or intubation.

  6. Intensive care unit admission [ Time Frame: 7 days ]
    Proportion of subjects requiring submission to the intensive care unit

  7. Plasma concentrations of Ibudilast [ Time Frame: 7 days ]
    Blood sample collection to determine plasma concentrations of ibudilast.

  8. All cause mortality [ Time Frame: Days 7, 14, 28 ]
    Number of deaths from any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04429555


Contacts
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Contact: Joanna Dojillo, MMsc 858-246-8679 dojillo@medicinova.com

Sponsors and Collaborators
MediciNova
Investigators
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Study Chair: Kazuko Matsuda, MD PhD MPH Medicinova Inc
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Responsible Party: MediciNova
ClinicalTrials.gov Identifier: NCT04429555    
Other Study ID Numbers: MN-166-COVID-19-201
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MediciNova:
COVID-19
Acute respiratory distress syndrome
Pneumonia
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Ibudilast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents