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First Patients Dosed in Phase 2/3 Clinical Trial for COVID-19

NEW YORK, NY (US), May 2020 — The first patients have been dosed in the 300-patient randomized placebo-controlled Phase 2/3 trial in the United States of Mesoblast Ltd.’s (Melbourne, Australia) allogeneic cellular medicine remestemcel-L in COVID-19 infected patients with moderate to severe acute respiratory distress syndrome (ARDS) on ventilator support. Mesoblast holds an Investigational New Drug (IND) application cleared by the FDA for use of remestemcel-L in the treatment of patients with COVID-19 ARDS.

The clinical protocol for the Phase 2/3 trial is based on initial promising results from use of remestemcel-L in patients with moderate to severe COVID-19 ARDS under an emergency IND application or expanded access protocol at Mount Sinai Hospital in New York. The trial will randomize up to 300 ventilator-dependent patients in intensive care units to either remestemcel-L or placebo (1:1) on top of maximal care, in line with specific guidance provided by the United States Food and Drug Administration (FDA) for robust statistical analysis. The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days alive and off mechanical support.

The trial will include up to 30 sites across North America, with patient screening and enrollment having already commenced at Baylor University Medical Center, a part of Baylor Scott & White Health; Cleveland Clinic, Duke University Hospital, Keck Medical Center of USC, Lutheran Hospital Indiana, Mount Sinai Hospital, Ochsner Medical Center – Jefferson Highway, and the University of Maryland School of Medicine/University of Maryland Medical Center. Enrollment is expected to complete within three to four months, with interim analyses planned which could result in stopping the trial early for efficacy or futility.

The Clinical and Data Coordinating Center for the trial will be overseen by Annetine Gelijns, Ph.D., J.D., Alan Moskowitz, M.D., and Emilia Bagiella, Ph.D., the co-directors of the Institute for Transformative Clinical Trials at the Icahn School of Medicine at Mount Sinai.

Dr. Moskowitz said, “This rapid mobilization of major medical centers across the United States reflects the urgent need to treat the very large numbers of people in hospital intensive care units suffering with COVID-19 ARDS and requiring ventilation. We expect quick enrollment in this trial to determine whether remestemcel-L can reduce mortality in these patients.”

Mesoblast’s proprietary cell technology platform is based on mesenchymal lineage adult stem cells. Remestemcel-L is being developed for various inflammatory conditions, including acute graft-versus-host disease, and is believed to counteract the inflammatory processes implicated in these diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

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