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

NCT04429555 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-10-30

Study results available
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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 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.

Conditions

  • Pneumonia, Viral

Interventions

DRUG

Ibudilast

50 mg (5 x 10 mg capsules) twice daily for 7 days

DRUG

Placebo

0 mg (5 matching capsules) twice daily for 7 days

Sponsors & Collaborators

  • MediciNova

    lead INDUSTRY

Principal Investigators

  • Kazuko Matsuda, MD PhD MPH · Medicinova Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2022-06-30
Completion
2024-08-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04429555 on ClinicalTrials.gov