Ibudilast for COVID-19

Recruiting at 1 trial location

Overseen By Kazuko Matsuda, MD, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MediciNova

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Intubation, Dialysis, Home ventilator, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 week

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing ibudilast in hospitalized COVID-19 patients who are at risk of severe lung problems. The drug aims to reduce inflammation and calm the immune response to prevent severe lung issues. Patients will receive the drug for a short period and be monitored for several weeks.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants will receive standard care, which includes anticoagulation therapy, so you may continue some treatments.

How is the drug Ibudilast unique for treating COVID-19?

Ibudilast is unique for treating COVID-19 because it is primarily known for its anti-inflammatory and neuroprotective properties, which may help reduce inflammation and support recovery in COVID-19 patients, unlike other treatments that mainly focus on direct antiviral effects. ^{1 2 3 4 5}

Who Is on the Research Team?

Kazuko Matsuda, MD PhD MPH

Principal Investigator

Medicinova Inc

Are You a Good Fit for This Trial?

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

Exclusion Criteria

On home ventilator support or continuous domiciliary O2 therapy for baseline lung disease

Active tuberculosis (TB) infection

You are currently taking medication that suppresses your immune system or have received chemotherapy recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive Ibudilast or placebo for 7 days along with standard of care and anticoagulation therapy

1 week

Daily visits (in-person) if hospitalized, or at-home monitoring if discharged

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments on Days 14 and 28

3 weeks

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Ibudilast
• Placebo

How Is the Trial Designed?

Group I: Active Treatment Group Experimental Treatment 1 Intervention

Group II: Placebo Treatment Group Placebo Group 1 Intervention

Ibudilast is already approved in Japan, United States for the following indications:

Approved in Japan as Ibudilast for:

• Bronchial asthma
• Cerebral vasospasm following subarachnoid hemorrhage

Approved in United States as MN-166 for:

• Multiple sclerosis
• Amyotrophic lateral sclerosis (ALS)
• Progressive multiple sclerosis
• Neuropathic pain

Who Is Running the Clinical Trial?

MediciNova

Lead Sponsor

Trials

21

Recruited

1,500+

Published Research Related to This Trial

A study involving 40 healthy male volunteers demonstrated that Sandoz generic montelukast 4 mg oral granules are bioequivalent to Singulair(®) 4 mg mini oral granules, meaning they have similar absorption and effectiveness in the body.

Both formulations showed a comparable safety profile, with only two mild adverse events reported, indicating that they can be used interchangeably in treating asthma and allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioequivalence of two formulations of montelukast sodium 4 mg oral granules in healthy adults. Fey, C., Thyroff-Friesinger, U., Jones, S.[2021]

The INTERCOP trial is investigating the efficacy of IFNβ-1a in treating COVID-19 in 126 patients with mild-to-moderate disease, focusing on its ability to speed up the negative conversion of SARS-CoV-2 and improve clinical outcomes.

IFNβ-1a has shown promise due to its antiviral activity against SARS-CoV-2 in previous studies, and if proven effective and safe, it could become a key treatment option for COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interferon β-1a (IFNβ-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial. Bosi, E., Bosi, C., Rovere Querini, P., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Oral prodrug of remdesivir parent GS-441524 is efficacious against SARS-CoV-2 in ferrets. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Bioequivalence of two formulations of montelukast sodium 4 mg oral granules in healthy adults. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Prospective, randomised, parallel-group, open-label study to evaluate the effectiveness and safety of IMU-838, in combination with oseltamivir, in adults with COVID-19: the IONIC trial protocol. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Nelfinavir: An Old Ally in the COVID-19 Fight? [2023]

5. England pubmed.ncbi.nlm.nih.gov

Interferon β-1a (IFNβ-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial. [2023]