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Phosphodiesterase inhibitor
Ibudilast for COVID-19
Phase 2
Waitlist Available
Research Sponsored by MediciNova
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 7, 14, 28 and 60 (day 60 applies to intubated subjects only)
Awards & highlights
Study Summary
This trial is testing whether a drug called MN-166 can help people with COVID-19 who are at risk of developing acute respiratory distress syndrome.
Eligible Conditions
- Viral Pneumonia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have one or more conditions that may make you more likely to experience severe symptoms from COVID-19. These include being over 65 years old, having heart disease or lung disease, having severe asthma, having a high body mass index (BMI) of 40 or more, or having diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 7, 14, 28 and 60 (day 60 applies to intubated subjects only)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 7, 14, 28 and 60 (day 60 applies to intubated subjects only)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects free from respiratory failure at Day 7
Proportion of subjects with at least a 1-point improvement in clinical status using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Day 7
Secondary outcome measures
Adverse event incidence and severity
All-cause mortality at Days 7,14, 28, and 60
Incidence of mechanical ventilation or intubation at Day 7, 14, 28, and 60
+4 moreSide effects data
From 2017 Phase 2 trial • 125 Patients • NCT0186080750%
Headache
17%
Nausea
16%
Insomnia
13%
Diarrhea
2%
Suicide Attempt
2%
Convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibudilast
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MN-166 (ibudilast)Experimental Treatment1 Intervention
MN-166 capsules, 50 mg twice daily, for 7 days.
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules, 50 mg twice daily, for 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibudilast
2013
Completed Phase 2
~340
Find a Location
Who is running the clinical trial?
MediciNovaLead Sponsor
19 Previous Clinical Trials
1,480 Total Patients Enrolled
Kazuko Matsuda, MD PhD MPHStudy ChairMedicinova Inc
4 Previous Clinical Trials
339 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking medication that suppresses your immune system or have received chemotherapy recently.You have one or more conditions that may make you more likely to experience severe symptoms from COVID-19. These include being over 65 years old, having heart disease or lung disease, having severe asthma, having a high body mass index (BMI) of 40 or more, or having diabetes.You receive dialysis treatment.You have a respiratory failure caused by something other than COVID-19, such as a bacterial, fungal, or viral infection.You have at least one condition that could make you more likely to have severe illness if you were to contract COVID-19. These conditions are: being over 65 years old, having serious heart or lung disease, having moderate to severe asthma, having a body mass index of 40 or greater or having diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: MN-166 (ibudilast)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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