Trial Outcomes & Findings for Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS (NCT NCT04429555)

Last Updated: 2024-10-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Day 7

Results posted on

2024-10-30

Participant Flow

* Full Analysis Set (FAS) will include all participants randomly assigned to Ibudilast or placebo. * Safety Analysis Set (SAS) will include all randomized subjects who received at least one dose of study drug and had at least one post-dose safety assessment. * Per Protocol Analysis (PP): will consist of the FAS subjects excluding those with major protocol violations. In this clinical trial, FAS, SAS, and PP analysis sets included all participants.

Participant milestones

Participant milestones
Measure	Ibudilast (MN-166) 50 mg (10 mg strength): 5 capsules taken by mouth twice daily for 7 days.	Placebo 0 mg: 5 capsules taken by mouth twice daily for 7 days.
Overall Study STARTED	17	17
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ibudilast (MN-166) 50 mg (10 mg strength): 5 capsules taken by mouth twice daily for 7 days.	Placebo 0 mg: 5 capsules taken by mouth twice daily for 7 days.
Overall Study Death	0	2
Overall Study Other	2	0

Baseline Characteristics

Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibudilast (MN-166) n=17 Participants 50 mg (10 mg strength): 5 capsules taken by mouth twice daily for 7 days.	Placebo n=17 Participants 0 mg: 5 capsules taken by mouth twice daily for 7 days.	Total n=34 Participants Total of all reporting groups
Age, Continuous	58.71 years STANDARD_DEVIATION 11.32 • n=5 Participants	61.06 years STANDARD_DEVIATION 12.16 • n=7 Participants	59.88 years STANDARD_DEVIATION 11.63 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7

Outcome measures

Outcome measures
Measure	Ibudilast (MN-166) n=17 Participants 50 mg (10 mg strength): 5 capsules taken by mouth twice daily for 7 days.	Placebo n=17 Participants 0 mg: 5 capsules taken by mouth twice daily for 7 days.
Number of Participants Free From Respiratory Failure at Day 7	12 Participants	6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ibudilast (MN-166) n=17 Participants 50 mg (10 mg strength): 5 capsules taken by mouth twice daily for 7 days.	Placebo n=17 Participants 0 mg: 5 capsules taken by mouth twice daily for 7 days.
Number of Participants With at Least a 1-point Improvement in Clinical Status on Day 7	12 Participants	8 Participants

SECONDARY outcome

Timeframe: Days 7, 14, and 28

Number (percentage) of participants receiving mechanical ventilation or intubation after starting study drug.

Outcome measures

Outcome measures
Measure	Ibudilast (MN-166) n=17 Participants 50 mg (10 mg strength): 5 capsules taken by mouth twice daily for 7 days.	Placebo n=17 Participants 0 mg: 5 capsules taken by mouth twice daily for 7 days.
Number of Participants Receiving Mechanical Ventilation or Intubation Day 7	1 Participants	3 Participants
Number of Participants Receiving Mechanical Ventilation or Intubation Day 14	1 Participants	2 Participants
Number of Participants Receiving Mechanical Ventilation or Intubation Day 28	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 60

Number of reported participant deaths

Outcome measures

Outcome measures
Measure	Ibudilast (MN-166) n=17 Participants 50 mg (10 mg strength): 5 capsules taken by mouth twice daily for 7 days.	Placebo n=17 Participants 0 mg: 5 capsules taken by mouth twice daily for 7 days.
All-cause Mortality	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Days 7, 14, and 28

Number (percentage) of participants discharged from hospital at Days 7, 14, and 28

Outcome measures

Outcome measures
Measure	Ibudilast (MN-166) n=17 Participants 50 mg (10 mg strength): 5 capsules taken by mouth twice daily for 7 days.	Placebo n=17 Participants 0 mg: 5 capsules taken by mouth twice daily for 7 days.
Number of Participants Discharged From Hospital at Days 7, 14, and 28 Day 7	11 Participants	5 Participants
Number of Participants Discharged From Hospital at Days 7, 14, and 28 Day 14	13 Participants	11 Participants
Number of Participants Discharged From Hospital at Days 7, 14, and 28 Day 28	13 Participants	14 Participants

Adverse Events

MN-166 (Ibudilast)

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 14 serious events

Other events: 14 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	MN-166 (Ibudilast) n=17 participants at risk 50 mg (10 mg strength): 5 capsules taken by mouth twice daily for 7 days.	Placebo n=27 participants at risk；n=17 participants at risk 0 mg: 5 capsules taken by mouth twice daily for 7 days.
Gastrointestinal disorders Constipation	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	11.8% 2/17 • Number of events 2 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Infections and infestations Bacteraemia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Gastrointestinal disorders Diverticulitis	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	17.6% 3/17 • Number of events 3 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Renal and urinary disorders Pneumonia	11.8% 2/17 • Number of events 3 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	11.8% 2/17 • Number of events 3 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Respiratory, thoracic and mediastinal disorders Respiratory failure	11.8% 2/17 • Number of events 2 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	17.6% 3/17 • Number of events 3 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Vascular disorders Shock	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.

Other adverse events

Additional Information

Malath Makhay

Medicinova Inc

Phone: 8582468680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	MN-166 (Ibudilast) n=17 participants at risk 50 mg (10 mg strength): 5 capsules taken by mouth twice daily for 7 days.	Placebo n=27 participants at risk；n=17 participants at risk 0 mg: 5 capsules taken by mouth twice daily for 7 days.
Blood and lymphatic system disorders Eosinophilia	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	17.6% 3/17 • Number of events 3 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Cardiac disorders Atrial fibrillation	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Cardiac disorders Bradycardia	41.2% 7/17 • Number of events 7 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	17.6% 3/17 • Number of events 3 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Cardiac disorders Sinus bradycardia	11.8% 2/17 • Number of events 2 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Cardiac disorders Supraventricular extrasystoles	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Cardiac disorders Supraventricular tachycardia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Endocrine disorders Glucose tolerance impaired	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Endocrine disorders Hyperglycaemia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	17.6% 3/17 • Number of events 3 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Gastrointestinal disorders Diarrhoea	17.6% 3/17 • Number of events 3 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	11.8% 2/17 • Number of events 3 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Gastrointestinal disorders Dyspepsia	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Gastrointestinal disorders Dysphagia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Gastrointestinal disorders Vomiting	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
General disorders Asthenia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Infections and infestations Clostridium difficile infection	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Infections and infestations Sepsis	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Infections and infestations Tooth abscess	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Infections and infestations Urinary tract infection	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Investigations Electrocardiogram QT prolonged	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Investigations Hepatic enzyme increased	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Investigations Transaminases increased	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	23.5% 4/17 • Number of events 4 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Nervous system disorders Encephalopathy	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Nervous system disorders Headache	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	11.8% 2/17 • Number of events 2 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Nervous system disorders Insomnia	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Nervous system disorders Intensive care unit acquired weakness	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Nervous system disorders Toxic encephalopathy	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Psychiatric disorders Anxiety	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Psychiatric disorders Depression	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Renal and urinary disorders Haematuria	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Reproductive system and breast disorders Scrotal pain	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	11.8% 2/17 • Number of events 2 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Respiratory, thoracic and mediastinal disorders Pneumonia staphylococcal	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Vascular disorders Hypotension	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	11.8% 2/17 • Number of events 2 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.
Vascular disorders Tongue haemorrhage	0.00% 0/17 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.	5.9% 1/17 • Number of events 1 • Adverse events occurring from the time of the first dose through 7 days after the last dose of MN-166 were recorded.