MediciNova has received authorization from Health Canada to initiate multi-arm Phase II/III clinical trial of MN-166 (ibudilast) to treat long-standing Covid.
Called REcovering from Covid-19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM), the placebo-controlled, adaptive, randomized, prospective, grant-funded trial will evaluate MN-166 and other therapies.
It will be conducted in partnership between MediciNova and the Canadian health research organization, the University Health Network.
In August last year, The company signed an agreement with the University Health Network to participate in the RECLAIM trial.
MediciNova will be responsible for supplying the study drug and providing ongoing regulatory and safety support.
The Canada-wide Phase II/III platform trial is designed to evaluate several interventions for the treatment of long-term Covid patients.
It has planned to recruit about 800 to 1,000 long-term Covid patients in Canadian countries.
MediciNova Chief Medical Officer Kazuko Matsuda said: “Since Covid-19 became a global health threat, many vaccines and treatment options have become available, however not many treatment options have been evaluated in the aftermath of Covid-19, the so-called long Covids.
“There is a large unmet medical need for patients with this disorder, which can have serious consequences on quality of life, health care utilization, 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 placebo, including standard of care for two months.
The participants will be followed for another four months.
The mean change in SF-36 physical component score (PCS) (v.1) from baseline to two months is the primary outcome of the trial.
