Ibudilast for COVID-19

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called Ibudilast to determine if it benefits hospitalized COVID-19 patients at risk for severe lung issues, such as acute respiratory distress syndrome (ARDS). The study compares Ibudilast to a placebo (a substance with no active drug) to assess its ability to reduce oxygen needs and improve clinical status over a month. The trial seeks participants who have tested positive for COVID-19, exhibit pneumonia-like symptoms, have low oxygen levels or breathing difficulties, and have conditions like serious heart disease or diabetes that increase their risk for severe illness. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that Ibudilast is likely to be safe for humans?

Research has shown that Ibudilast, also known as MN-166, has been promising in earlier studies. These studies have assessed its safety and effectiveness for various conditions. Importantly, patients have generally tolerated Ibudilast well. Reports from these studies indicate that side effects were usually mild and manageable.

Although limited information exists on side effects in COVID-19 patients, Ibudilast has been studied in other contexts. This research suggests it rarely causes serious side effects. If side effects occur, they are usually mild, such as headaches or an upset stomach.

This trial is in a middle phase, indicating some existing evidence of safety. New treatments typically reach this phase only after demonstrating safety in earlier tests. While more research is needed, past data provides a reasonable expectation of safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Ibudilast is unique because it offers a fresh approach to treating COVID-19 by targeting inflammation and brain function. Unlike traditional COVID-19 treatments such as antivirals or monoclonal antibodies, which primarily aim to reduce viral load, Ibudilast works as an anti-inflammatory and neuroprotective agent. This different mechanism of action could help alleviate long-term neurological symptoms some COVID-19 patients experience, making it an exciting prospect for researchers.

What evidence suggests that Ibudilast might be an effective treatment for COVID-19?

Research has shown that Ibudilast (MN-166), which participants in this trial may receive, might help treat COVID-19, particularly for those at risk of serious lung issues. Early results suggest that Ibudilast may reduce the need for oxygen therapy in patients. Some studies have reported positive outcomes, such as improved breathing and milder symptoms compared to a placebo. Ibudilast has generally been found to be safe. These findings make it a promising option for treating severe cases of COVID-19. ^{1 2 4 6 7}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT04429555

Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04429555?cond=%22Acute%20Lung%20Injury%22&intr=%22phosphodiesterase%20inhibitors%22&viewType=Table&rank=1

Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

3. investors.medicinova.com investors.medicinova.com/news-releases/news-release-details/medicinova-announces-positive-top-line-results-phase-2-clinical

MediciNova Announces Positive Top-Line Results from ... MediciNova Announces Positive Top-Line Results from Phase 2 Clinical Trial of MN-166 (ibudilast) in Hospitalized COVID-19 Patients at Risk for ...

4. ctv.veeva.com ctv.veeva.com/study/efficacy-safety-tolerability-and-biomarkers-of-mn-166-ibudilast-in-patients-hospitalized-with-c

Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN ... 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 ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/medicinova-subject-enrolment-trial-mn166/

MediciNova concludes subject enrolment in trial of MN-166 Top-line results are anticipated by the end of next year. Previous studies of MN-166 showed a positive safety profile and indications of ...

6. investors.medicinova.com investors.medicinova.com/news-releases/news-release-details/medicinova-announces-new-data-and-results-mn-166-ibudilast

MediciNova Announces New Data and Results of MN-166 ... The primary objective of this nonclinical efficacy study was to determine the safety and pharmacological activity of MN-166 (ibudilast) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10034329/

Therapeutic trials for long COVID-19: A call to action from the ... Enrollment of 168 participants in a placebo-controlled trial evaluating deupirfenidone (LYT-100) for treatment of post acute COVID-19 respiratory complications ...