Colorised scanning electron micrograph of an apoptotic cell (purple) heavily infected with SARS-COV-2 virus particles (yellow). Credit: NIAID.

Researchers at Yale University in the US are set to initiate a clinical trial of ibudilast (MN-166) to treat acute respiratory distress syndrome (ARDS) in Covid-19 patients.

The trial will be conducted at Yale-New Haven Hospital to assess the drug’s effectiveness.

Ibudilast, which has approvals in Japan and Korea to treat asthma, demonstrated promise in decreasing inflammation related ARDS in mouse models.

The researchers, part of Yale’s Advanced Therapies Group that formed identify and study potential Covid-19 treatments, partnered with MediciNova to perform the trial.

MediciNova was developing ibudilast as a multiple sclerosis and neuroinflammation treatment before focusing on the novel coronavirus infection.

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The Covid-19 trials will have a controlled design to asses the safety and efficacy of the drug.

Researchers expect to soon receive US Food and Drug Administration (FDA) approval to treat Covid-19 pneumonia before disease progresses to severe respiratory distress and requires mechanical ventilation.

Yale School of Medicine rheumatology, allergy and immunology chief Dr Richard Bucala said: “We are excited for this partnership opportunity to initiate this study, given the high morbidity and mortality of Covid-19, and the present lack of any evidence-based therapies.

“We additionally hope that insights from this trial will help us to better understand how ARDS develops, irrespective of its underlying cause.”

Ibudilast is an inhibitor of the MIF gene, which regulates the immune response known to drive inflammation and the ‘cytokine storm’.

Over-expression of macrophage inhibitory factor (MIF) is linked to multiple disease, including ARDS, asthma, rheumatoid arthritis, lupus and multiple sclerosis.

Yale University medicine assistant professor Maor Sauler noted: “We have designed a placebo-controlled trial to see if blocking the effects of macrophage inhibitory factor, or MIF, can protect patients with Covid-19 from developing ARDS.”