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
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia, Viral||Drug: Ibudilast Drug: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blind, placebo-controlled, parallel-group study.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||January 11, 2021|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 1, 2021|
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 Name: MN-166
Placebo Comparator: Placebo
Placebo capsules, 50 mg twice daily, for 7 days.
Placebo orally administered, 50 mg twice daily for 7 days.
- 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.
- 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
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
|Contact: Kazuko Matsuda, MD, PhD, MPHemail@example.com|
|United States, Colorado|
|Denver Health and Hospital Authority||Recruiting|
|Denver, Colorado, United States, 80204|
|Contact: Yeni Rodriguez Villalobos 303-602-6048 firstname.lastname@example.org|
|Contact: Ruth Magtanong 303-602-4367 email@example.com|
|Principal Investigator: David Wyles, MD|
|Sub-Investigator: Ivor Douglas, MD|
|United States, Connecticut|
|Yale University School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Linda Koumpouras firstname.lastname@example.org|
|Contact: Jessica Nouws email@example.com|
|Principal Investigator: Maor Sauler, MD|
|Sub-Investigator: Geoffrey Chupp, MD|
|Study Chair:||Kazuko Matsuda, MD PhD MPH||Medicinova Inc|