- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04429555
Efficacy, Safety, Tolerability, and Biomarkers of MN-166 (Ibudilast) in Patients Hospitalized With COVID-19 and at Risk for ARDS
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Colorado
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Denver, Colorado, United States, 80204
- Denver Health and Hospital Authority
-
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University School Of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MN-166 (ibudilast)
MN-166 capsules, 50 mg twice daily, for 7 days.
|
Ibudilast orally administered, 50 mg twice daily for 7 days.
Other Names:
|
Placebo Comparator: Placebo
Placebo capsules, 50 mg twice daily, for 7 days.
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Placebo orally administered, 50 mg twice daily for 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects free from respiratory failure at Day 7
Time Frame: Day 7
|
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. The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
|
Day 7
|
Proportion of subjects with at least a 1-point improvement in clinical status using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Day 7
Time Frame: Day 7
|
Percentage of subjects who improved at least by 1 point in the National Institute of Allergy and Infectious Diseases 8-point scale and discharge record at Day 7. The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event incidence and severity
Time Frame: Days 7, 14, 28 and 60 (Day 60 applies to intubated subjects only)
|
Incidence, frequency, and severity of adverse events
|
Days 7, 14, 28 and 60 (Day 60 applies to intubated subjects only)
|
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 Days 14, 28, and 60
Time Frame: Days 14, 28, and 60 (Day 60 applies to intubated subjects only)
|
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 Days 14, 28, and 60 (Day 60 applies to intubated subjects only).
The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
|
Days 14, 28, and 60 (Day 60 applies to intubated subjects only)
|
Mean change from baseline in clinical status at Days 7, 14, 28, and 60
Time Frame: Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)
|
Mean change from baseline in clinical status at Days 7,14, 28, and 60 using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only).
The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
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Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)
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Incidence of mechanical ventilation or intubation at Day 7, 14, 28, and 60
Time Frame: Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)
|
Proportion of subjects receiving mechanical ventilation or intubation at Days 7, 14, 28, and 60
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Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)
|
Proportion of subjects with at least a 1-point improvement in clinical status at Days 14, 28, and 60
Time Frame: Days 14, 28, and 60 (Day 60 applies to intubated subjects only)
|
Proportion of subjects with at least a 1-point improvement in clinical status at Days 14, 28, and 60 using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Days 7, 14, and 60.
The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
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Days 14, 28, and 60 (Day 60 applies to intubated subjects only)
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All-cause mortality at Days 7,14, 28, and 60
Time Frame: Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)
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Number of deaths from any cause
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Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)
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Proportion of subjects discharged from hospital at Days 7,14, 28, and 60
Time Frame: Days 7, 14, 28, and 60
|
Proportion of subjects discharged from hospital at Days 7,14, 28, and 60 (Day 60 applies to intubated subjects only)
|
Days 7, 14, 28, and 60
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kazuko Matsuda, MD PhD MPH, Medicinova Inc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- COVID-19
- Pneumonia
- Pneumonia, Viral
- Respiratory Distress Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Platelet Aggregation Inhibitors
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Phosphodiesterase Inhibitors
- Ibudilast
Other Study ID Numbers
- MN-166-COVID-19-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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