MediciNova has received authorisation from Health Canada to initiate the multi-arm Phase II/III clinical trial of MN-166 (ibudilast) to treat long Covid.
Named the REcovering from Covid-19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM) trial, the placebo-controlled, adaptive, randomised, prospective, grant-funded trial will assess MN-166 and other therapies.
It will be conducted in partnership between MediciNova and the Canadian health research organisation, University Health Network.
In August last year, the company signed an agreement with University Health Network to take part in the RECLAIM trial.
MediciNova will be responsible for supplying the study drug and providing regulatory and safety follow-up support.
The Canada-wide Phase II/III platform trial has been designed for assessing several interventions to treat long Covid patients.
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It has planned to recruit nearly 800 to 1000 long Covid patients at Canadian sites.
MediciNova chief medical officer Kazuko Matsuda said: “Since Covid-19 became a global health threat, multiple vaccines and treatment options became available, yet not many treatment options have been evaluated in Covid-19 sequelae, so-called Long Covid.
“There is a large unmet medical need for patients with this disorder, which can have serious ramifications on quality of life, health care utilisation, and ability to return to work.”
In the trial, participants will be randomly assigned to one of four arms to receive MN-166, pentoxifylline, or their respective matching placebos, including standard of care, for two months.
The participants will be followed for an additional four months.
The mean change in the SF-36 (v.1) physical component score (PCS) from baseline to two months is the trial’s primary outcome.