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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 7, 14, and 28
Summary
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.
Eligible Conditions
- Viral Pneumonia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 7, 14, and 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 7, 14, and 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Free From Respiratory Failure at Day 7
Number of Participants With at Least a 1-point Improvement in Clinical Status on Day 7
Secondary study objectives
All-cause Mortality
Number of Participants Discharged From Hospital at Days 7, 14, and 28
Number of Participants Receiving Mechanical Ventilation or Intubation
Side 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: Active Treatment GroupExperimental Treatment1 Intervention
Group II: Placebo Treatment GroupPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibudilast
2016
Completed Phase 2
~410
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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
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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.
Research Study Groups:
This trial has the following groups:- Group 1: Active Treatment Group
- Group 2: Placebo Treatment Group
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.
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