Miami Cancer Institute, part of Baptist Health South Florida, has initiated several clinical trials based on treatments from initial emergency and experimental COVID-19 therapies.
The institute is leading a trial using mesenchymal stem cells for critically ill patients with SARS-CoV-2 induced respiratory failure. It is also the location of the phase II, BLAZE-4 trial, which continues work on bamlanivimab, a monoclonal antibody recently awarded Emergency Use Authorization status by FDA for those with mild COVID-19 symptoms.
Early in the pandemic, Miami Cancer Institute received single-use emergency approval from the FDA to give mesenchymal stem cells to several COVID-19 patients who were critically ill. The patients recovered. The stem cells aid in healing by regenerating damaged lung tissue. The formal, phase I/IIa trial opening now is for hospitalized patients who are receiving oxygen therapy or who are on ventilation support and are not showing improvement with other therapies.
The Florida Department of Health is allocating bamlanivimab for EUA use and Baptist Health has a limited supply. Miami Cancer Institute participated in the monoclonal antibody’s phase I study, BLAZE-1, which led to the EUA. Now the Institute is enrolling patients in the phase II study, BLAZE-4.
Bamlanivimab can be given as an IV infusion to COVID-19-positive patients who are not hospitalized and have mild symptoms. It must be administered within 72 hours of a positive test result. It works by prohibiting the virus from anchoring to ACE2 receptors, which are proteins on the surface of many cells that allow the SARS-CoV-2 virus to enter and infect cells. In the initial study, it showed a subsequent hospitalization rate of 1.7% among those who received the drug versus a 6% hospitalization rate among those who received a placebo.
The BLAZE-4 trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of bamlanivimab (also known as LY3819253) both on its own and in combination with another monoclonal antibody specific to target the spike protein of SARS-CoV-2 to prevent the virus from entering into the epithelial cells (LY3832479). There are five arms to the trial. Arm 1 is a placebo. Arms 2, 3 and 4 consist of bamlanivimab plus a second monoclonal antibody (both given in different dosages). Arm 5 is bamlanivimab alone.
The first trial showed that bamlanivimab may reduce viral load, symptoms and risk of hospitalizations and emergency room visits associated with COVID-19 and this trial may further improve the outcomes.
