Recently, doctors in China saw positive results when they treated severely ill Covid19 patients with a single dose of antibodies drawn from the blood of Covid19 survivors; the U.S. began clinial trials on the treatment. While awaiting a green signal from the ICMR to launch similar clinical trials in India, a private hospital in Delhi has already used it on critically ill Covid19 patients at the request of their family members. In the meantime, the U.S. has begun trials to evaluate whether an artificial antibody called gimsilumab could reduce the risk of death among Covid19-patients.
Scientists believe that gimsilumab — an artificially synthesized antibody — can potentially reduce death risk among patients infected by Covid19. Gimsilumab is a man-made antibody made by cloning a unique cell that is immune to a particular infection — in a bid to manufacture multiple identical immune cells. While plasma therapy, which uses antibody-rich blood drawn from Covid19 survivors, relies on the survivors’ willingness to donate their blood, gimsilumab can be mass-manufactured in laboratories.
Studies suggest that Covid19 patients are prone to experiencing acute respiratory distress syndrome (ARDS), which is a life-threatening inflammatory lung injury and has an overall fatality rate of 41 percent. Gimsilumab is designed to specifically target the factors which cause such hyper-inflammation of lungs, which is why scientists believe it could have applicability to Covid19 treatment.
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The trial is sponsored by Roivant Sciences, a Switzerland-based pharmaceutical company, and will accept up to 270 patients with confirmed cases of Covid19, who are experiencing ARDS. At present, Temple University Hospital in the U.S. has already begun intravenous treatment with gimsilumab on at least one patient, Reuters reported. The main aim of the new study is to record the incidence of mortality at the end of 43 days. In addition, it also aims to monitor the the incidence and duration of ventilation usage, if required, during the study, as well as number of days spent in ICUs, or regular hospitalization units.
Previously, gimsilumab had been tested in several clinical and non-clinical studies, including a four-week study for lung-inflammation, but not in a Covid19-context.
“[This] appears promising for reducing lung injury and death in this aggressive illness. The rapid initiation of this pivotal trial with gimsilumab is impressive given the pressing need for effective therapies that reduce the morbidity encountered with Covid19,” Dr. Mandeep Mehra, Professor of Medicine at Harvard Medical School, told Clinical Trials Arena.
