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Posted On: 11/08/2020 8:09:07 AM
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https://www.crainsnewyork.com/health-pulse/sa...il-hearing
Article about CYDY trials in New York
Montefiore to lead trial of patients with long-term Covid symptoms
Montefiore Medical Center will be participating in and leading a clinical trial exploring the use of a drug that regulates the immune system for patients suffering lingering symptoms following a Covid-19 infection.
The Bronx-based hospital will be recruiting up to 60 of the 100 patients in a phase three study of leronlimab, a monoclonal antibody drug that blocks precursors of inflammation, said Dr. Harish Seethamraju, medical director of the advanced lung failure and lung transplant program.
The trial should start in about three weeks, said Nader Pourhassan, president and CEO of CytoDyn, the Vancouver, Wash.–based pharmaceutical company developing the drug.
The protocol of the eight-week trial, which costs about $5 million, will be submitted to the U.S. Food and Drug Administration next week, Pourhassan said. The study will examine how the drug improves fatigue among other lingering symptoms, he added.
Montefiore will be the only New York hospital involved in this study as well as an ongoing phase three trial of leronlimab in severe-to-critical Covid-19 patients, Seethamraju said. The hospital, which recruited 19 patients for the current trial, had also led a phase two trial on mild-to-moderate Covid-19 disease, he added.
The trial for severe-to-critical Covid-19 patients, which costs about $9 million, has recruited 247 of its targeted 390 patients, Pourhassan said. The FDA has agreed to review its efficacy results at the 75% recruitment point, which could be hit as soon as next week, Seethamraju said.
"This could potentially grant it emergency-use authorization for a segment of Covid-19 patients who don't have any available options," Seethamraju said.
https://www.crainsnewyork.com/health-pulse/sa...il-hearing
Article about CYDY trials in New York
Montefiore to lead trial of patients with long-term Covid symptoms
Montefiore Medical Center will be participating in and leading a clinical trial exploring the use of a drug that regulates the immune system for patients suffering lingering symptoms following a Covid-19 infection.
The Bronx-based hospital will be recruiting up to 60 of the 100 patients in a phase three study of leronlimab, a monoclonal antibody drug that blocks precursors of inflammation, said Dr. Harish Seethamraju, medical director of the advanced lung failure and lung transplant program.
The trial should start in about three weeks, said Nader Pourhassan, president and CEO of CytoDyn, the Vancouver, Wash.–based pharmaceutical company developing the drug.
The protocol of the eight-week trial, which costs about $5 million, will be submitted to the U.S. Food and Drug Administration next week, Pourhassan said. The study will examine how the drug improves fatigue among other lingering symptoms, he added.
Montefiore will be the only New York hospital involved in this study as well as an ongoing phase three trial of leronlimab in severe-to-critical Covid-19 patients, Seethamraju said. The hospital, which recruited 19 patients for the current trial, had also led a phase two trial on mild-to-moderate Covid-19 disease, he added.
The trial for severe-to-critical Covid-19 patients, which costs about $9 million, has recruited 247 of its targeted 390 patients, Pourhassan said. The FDA has agreed to review its efficacy results at the 75% recruitment point, which could be hit as soon as next week, Seethamraju said.
"This could potentially grant it emergency-use authorization for a segment of Covid-19 patients who don't have any available options," Seethamraju said.
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