The world-renowned Cleveland University Hospital and the publicly traded biotech company Athersys (NASDAQ: ATHX) are ready to launch the second phase of the MACOVIA clinical trial in early May 2020.
The world-renowned Cleveland Hospital for Lung Service is the first open site to conduct the MultiStem Administration for COVID-19 Induced Acute Distress Respiratory Syndrome (MACOVIA) clinical trial.
Cleveland is one of the world’s most developed biotech cities. It is one of the only “cluster” concerning biotechnology.
On April 13, 2020, Athersys obtained approval from the U.S. Food and Drug Administration (FDA) to begin the MACOVIA study with the Fast Track label. The hospital then began the process of starting the clinical trial, which includes the registration of 400 subjects in a completely random and anonymous manner with COVID-19.
Acute Respiratory Distress Syndrome (EDS) is the leading cause of death in patients infected with COVID-19, according to the World Health Organization and other recent clinical and epidemiological data.
With no FDA-approved drug and the spread of COVID-19, there is an immediate need for therapies for the treatment of SDRA. THE MACOVIA treatment could be the treatment expected after the promising data of Athersys and its clinical trial Phase I / II of the MUST-ARDS trial
The MACOVIA trial aims to confirm the safety and efficacy of MultiStem therapy as a treatment for patients with moderate to severe EDS due to COVID-19.
The primary endpoint of the macOVIA efficacy will be the number of fan-free days up to the 28th day compared to placebo. Secondary objectives are to assess clinical parameters (e.g., time in the intensive care unit), lung function, causes of death, tolerability and quality of life (QV) in survivors.
If the MultiStem clinical trial is found to be effective, safe and tolerable, the company will further evaluate the treatment with a double-blind, randomized, placebo-controlled trial protocol (phase 3).