Roche, a global pioneer in the pharmaceutical sector, reportedly announced that it has started its global phase III, double-blind, randomized, multicenter clinical trial (REMDACTA) in partnership with Gilead Sciences to evaluate the efficacy and safety of RoActemra/Actemra along with the investigational antiviral drug, remdesivir, against placebo combined with remdesivir in patients suffering from severe COVID-19 pneumonia.
Head of Global Product Development and Chief Medical Officer at Roche, Levi Garraway, MD, PhD, stated that as more data about coronavirus pneumonia becomes available during this unprecedented period, it is extremely important to closely work together and combat this disease. Based on the company’s present understanding, a combination of an antiviral and an immune modulator can potentially prove to be an approach that proves to be effective to treat critical patients.
Garraway further added that the company is thrilled to collaborate with Gilead to evaluate whether the combination of these medicines would be of help to more patients in this pandemic.
The Phase 3 trial is scheduled to begin in June of 2020 with the enrolment of approximately 450 patients throughout the world.
Besides REMDACTA, the company is also close to finishing the enrollment of patients for the global randomized, placebo-controlled, double-blind phase 3 clinical study, COVACTA. This trial is being conducted to evaluate the efficacy and safety of intravenous RoActemra/Actemra plus SOC (standard of care), against placebo plus SOC in adult hospitalized patients suffering from severe COVID-19 pneumonia.
The first patient in the trial was randomized on April 3. In all, about 450 patients would be taking part in the COVACTA trial, an increase from the initial patient count of 330, which would enable the company to gain more strong data, while slightly extending the enrolment period.
Additionally, the protocol for COVACTA enables the inclusion of patients who are already being treated with antivirals, which also includes investigational antivirals. The insights and date from the REMDACTA trial would supplement the COVACTA trial.
Source credit: https://www.roche.com/media/releases/med-cor-2020-05-28.htm