A multi-center international trial studying the immunoregulatory and regenerative potential of MRG-001 in severe and critically ill COVID-19 patients has been initiated by MedRegen. During this phase 2a study, 40 patients will be randomized to placebo or MRG-001 treatment. After 40 patients have been included, an interim-analysis will take place to assess the safety, tolerability and for the purpose of sample-size reestimation.
This trial was unfortunately prematurely deactivated in May 2024, due to poor recruitment. The COVID-19 trial was deactivated due to a significant reduction in the number of severely ill patients on ventilators, because of a high vaccination degree and the introduction of oral medication to prevent severe disease, making recruitment slow and inefficient. This decline in eligible participants compromised the feasibility of conducting the study effectively within the projected timeline. Instead, Medregen will shift its focus in studying patients with ARDS of all etiologies in future trials.