Pneumonia, ViralPhase 2NCT04429555
Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS
A Phase 2 study testing Ibudilast in people with Pneumonia, Viral, run by MediciNova at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumonia, Viral
- What is being tested?
- Ibudilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jan 2021to 7 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Denver Health and Hospital Authority
Denver, Colorado, 80204
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
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
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.
Read the detailed description
This is a randomized (1:1) double-blind, placebo-controlled, parallel-group study evaluating the efficacy of Ibudilast to prevent ARDS in hospitalized patients infected with COVID-19 who are at risk for developing ARDS. The study will consist of a Screening Phase, Double-Blind Treatment Phase, and Follow-up Phase. Following the Screening Phase, if the participant meets eligibility criteria, they will be randomly assigned to Ibudilast or matching placebo. Participants will receive Ibudilast 100 mg/d (50 mg twice a day) 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. Participants discharged prior to Day 7 will be given the remainder of their study medication (Ibudilast or placebo) to be taken at home twice daily until Day 7 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 Informed Consent Form (ICF): inclusion/exclusion criteria review, physical exam, vital signs and oxygen use, clinical status using the NIAID ordinal scale, 12-lead ECG, blood collection for plasma biomarkers. A complete blood count (CBC), comprehensive metabolic panel (CMP), D-dimer and coagulation tests will also be drawn. A serum pregnancy test will be given to pre-menopausal female participants. Concomitant medications taken within the last 7 days prior to study drug administration will be recorded.
During the Treatment Phase, hospitalized participants will be treated with Ibudilast or placebo for a 7-day period plus standard of care and anticoagulation therapy. During the Treatment Phase, participants will undergo study-related procedures including physical exam, ECG, oxygen use assessment, biomarkers and pharmacokinetic sample draws, CBC, CMP, D-dimer blood collection, clinical status 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, participant's clinical status and survival status will be recorded.
If the participant is discharged before Day 7, they will be given the remainder of their study drug to take at home for up to 7 days, and the Sponsor will supply a pulse oximeter to participants to measure their oxygen levels once daily until Day 14.
- Conditions
- Pneumonia, Viral
- Being tested
- Ibudilast, Placebo
- Keywords
- COVID-19, Acute respiratory distress syndrome, Pneumonia
- Medical subject headings
- Pneumonia, Viral, COVID-19, Respiratory Distress Syndrome, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbudilastDrug
Also called MN-166
50 mg (5 x 10 mg capsules) twice daily for 7 days
PlaceboDrug
0 mg (5 matching capsules) twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Experimental | Not described Receives: Drug: Ibudilast |
| Placebo Treatment Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 7
Secondary outcomes (3)
Number of Participants Receiving Mechanical Ventilation or Intubation
Number (percentage) of participants receiving mechanical ventilation or intubation after starting study drug.
Measured: Days 7, 14, and 28
All-cause Mortality
Number of reported participant deaths
Measured: Day 1 to Day 60
Number of Participants Discharged From Hospital at Days 7, 14, and 28
Number (percentage) of participants discharged from hospital at Days 7, 14, and 28
Measured: Days 7, 14, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start11 Jan 2021
- Primary completion30 Jun 2022
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediciNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kazuko Matsuda, MD PhD MPH, Study chair, Medicinova Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429555
- Sponsor's protocol ID
- MN-166-COVID-19-201
- Status last verified
- Oct 2024
- First submitted
- 9 Jun 2020
- Last updated
- 30 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wyles DL, Matsuda K, Iwaki Y, Klonowski E. Effect of MN-166 (ibudilast) on acute respiratory failure prevention in hospitalized participants with COVID-19: a randomized, double-blind, placebo-controlled phase 2 study. BMC Pulm Med. 2026 Apr 2;26(1):218. doi: 10.1186/s12890-026-04261-8.
PubMed 41928198
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04429555
- Acronym / sponsor ID
- MN-166-COVID-19-201
- Conditions
- Pneumonia, Viral
- Keywords
- COVID-19, Acute respiratory distress syndrome, Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- MediciNovaIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Posted 30 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized (1:1) double-blind, placebo-controlled, parallel-group study evaluating the efficacy of Ibudilast to prevent ARDS in hospitalized patients infected with COVID-19 who are at risk for developing ARDS. The study will consist of a Screening Phase, Double-Blind Treatment Phase, and Follow-up Phase. Following the Screening Phase, if the participant meets eligibility criteria, they will be randomly assigned to Ibudilast or matching placebo. Participants will receive Ibudilast 100 mg/d (50 mg twice a day) 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. Participants discharged prior to Day 7 will be given the remainder of their study medication (Ibudilast or placebo) to be taken at home twice daily until Day 7 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 Informed Consent Form (ICF): inclusion/exclusion criteria review, physical exam, vital signs and oxygen use, clinical status using the NIAID ordinal scale, 12-lead ECG, blood collection for plasma biomarkers. A complete blood count (CBC), comprehensive metabolic panel (CMP), D-dimer and coagulation tests will also be drawn. A serum pregnancy test will be given to pre-menopausal female participants. Concomitant medications taken within the last 7 days prior to study drug administration will be recorded.
During the Treatment Phase, hospitalized participants will be treated with Ibudilast or placebo for a 7-day period plus standard of care and anticoagulation therapy. During the Treatment Phase, participants will undergo study-related procedures including physical exam, ECG, oxygen use assessment, biomarkers and pharmacokinetic sample draws, CBC, CMP, D-dimer blood collection, clinical status 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, participant's clinical status and survival status will be recorded.
If the participant is discharged before Day 7, they will be given the remainder of their study drug to take at home for up to 7 days, and the Sponsor will supply a pulse oximeter to participants to measure their oxygen levels once daily until Day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Experimental | Drug: Ibudilast |
| Placebo Treatment Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbudilastAlso: MN-16650 mg (5 x 10 mg capsules) twice daily for 7 days | Drug | Active Treatment Group |
| Placebo0 mg (5 matching capsules) twice daily for 7 days | Drug | Placebo Treatment Group |
Primary outcome
Number of Participants Free From Respiratory Failure at Day 7
Time frame: 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.
Number of Participants With at Least a 1-point Improvement in Clinical Status on Day 7
Time frame: 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.
3 secondary outcomes
Number of Participants Receiving Mechanical Ventilation or Intubation
Time frame: Days 7, 14, and 28
All-cause Mortality
Time frame: Day 1 to Day 60
Number of Participants Discharged From Hospital at Days 7, 14, and 28
Time frame: Days 7, 14, and 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41928198Wyles DL, Matsuda K, Iwaki Y, Klonowski E. Effect of MN-166 (ibudilast) on acute respiratory failure prevention in hospitalized participants with COVID-19: a randomized, double-blind, placebo-controlled phase 2 study. BMC Pulm Med. 2026 Apr 2;26(1):218. doi: 10.1186/s12890-026-04261-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuko Matsuda, MD PhD MPH study chair
Medicinova Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibudilast in people with Pneumonia, Viral, run by MediciNova at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Free From Respiratory Failure at Day 7 (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04429555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.