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

NCT04429555 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MN-166-COVID-19-201
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to evaluate the effects of Ibudilast (MN-166) versus placebo in hospitalized patients infected with COVID-19 at risk for developing acute respiratory distress syndrome (ARDS) receiving standard of care (including anticoagulation therapy) by measuring the following outcomes: 1) the need for oxygen therapy at Days 7, 14, and 28, 2) clinical status as measured by the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale at Days 7, 14, and 28, and 3) safety (as measured by incidence of adverse events and clinical laboratory findings) and tolerability of Ibudilast.

Conditions

Pneumonia, Viral

Keywords

COVID-19; Acute respiratory distress syndrome; Pneumonia

Outcome Measures

Primary Outcomes (2)

• Number of Participants Free From Respiratory Failure at Day 7

  Participants were considered "responders" if they did not meet the need for supplemental oxygen requirements (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at the end of the 7-day double-blind treatment.

  Day 7

• Number of Participants With at Least a 1-point Improvement in Clinical Status on Day 7

  Number (percentage) of participants with at least a 1-point improvement in clinical status on Day 7. Clinical status is measured by the National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale: 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 Outcomes (3)

• Number of Participants Receiving Mechanical Ventilation or Intubation

  Days 7, 14, and 28

• All-cause Mortality

  Day 1 to Day 60

• Number of Participants Discharged From Hospital at Days 7, 14, and 28

  Days 7, 14, and 28

Study Arms (2)

Active Treatment Group

EXPERIMENTAL

Drug: Ibudilast

Placebo Treatment Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ibudilast DRUG

50 mg (5 x 10 mg capsules) twice daily for 7 days

Also known as: MN-166

Active Treatment Group

Placebo DRUG

0 mg (5 matching capsules) twice daily for 7 days

Placebo Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, computerized tomography (CT) scan or lung ultrasound) with abnormalities consistent with COVID-19 pneumonia
• Oxygen saturation (SpO2) ≤92% on room air (RA), respiratory rate ≥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

You may not qualify if:

• 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
• Patient is receiving dialysis treatment
• On a home ventilator support or continuous domiciliary oxygen therapy for baseline lung disease
• Active tuberculosis infection

Sponsors & Collaborators

• MediciNova: lead

Study Sites (2)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Pneumonia, Viral; COVID-19; Respiratory Distress Syndrome; Pneumonia

Interventions

ibudilast

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiration Disorders

Results Point of Contact

• Title: Malath Makhay
• Organization: Medicinova Inc

makhay@medicinova.com

8582468680

Study Officials

• Kazuko Matsuda, MD PhD MPH

  Medicinova Inc

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel-group study.

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 12, 2020
• Study Start: January 11, 2021
• Primary Completion: June 30, 2022
• Study Completion: August 7, 2024
• Last Updated: October 30, 2024
• Results First Posted: October 30, 2024

Record last verified: 2024-10

Locations

US (2)