Humanetics Corporation Expands Long-Haul COVID-19 Trial to Additional Sites
Four sites now enrolling patients in study of new drug to mitigate long COVID lung injury
Minneapolis, MN – Humanetics Corporation (Humanetics) has added two additional clinical sites to its long-haul COVID-19 study, which is focused on patients who were treated for severe COVID-19 and face the possible risk that their respiratory complications will lead to long-term impairment of lung function. The new sites that are now enrolling patients are Montefiore Medical Center (Bronx, NY) and the University of Texas Health Science Center at Houston (Houston, TX). These sites join existing sites at NYU Langone and the Houston Methodist Research Institute.
The clinical study is designed to evaluate the ability of Humanetics new drug, BIO 300, to mitigate long-term pulmonary damage. The study will compare the lung function, exercise capacity, and quality of life in COVID-19 survivors who receive BIO 300, against a group receiving a placebo. BIO 300 is an oral drug that patients self-administer daily for 12 weeks following discharge from the hospital. The primary endpoint of the trial is 12 weeks after the start of dosing and patients will be followed for one year.
Emerging COVID-19 studies indicate that a high number of infected individuals exhibit signs of lung injury within the first few weeks of infection, and that as many as 50% of patients have signs of pulmonary fibrosis and/or impaired lung function at the time of hospital discharge. Pulmonary fibrosis results in permanent scarring of the lungs, which can impair breathing and greatly impact a person’s quality of life.
“We don’t fully understand the long-term effects of COVID-19 and are concerned that discharged patients will continue to suffer respiratory complications,” said Michael Kaytor, PhD, Vice President of Research for Humanetics and the program director for the study. “Most attention thus far has been on treating the acute phase of COVID-19 and now attention is being shifted to the long-term effects of the initial infection.”
BIO 300 is under advanced development as a medical countermeasure to protect the body from harm caused by ionizing radiation. It was initially discovered by researchers at the US Department of Defense in their efforts to create radioprotective drugs for the military. Humanetics further expanded applications for the drug into cancer radiation therapy and recently completed a clinical trial in lung cancer patients who develop pulmonary injury related to their radiation treatments. Radiation-induced injury to normal lung tissue in cancer patients is similar to lung injury caused by the COVID-19 virus. BIO 300 has been shown to mitigate inflammation of the lungs and pulmonary fibrosis caused by radiation. It is believed that the same effect can be shown in COVID-19 patients.
This clinical trial is being funded by the National Institute of Allergy and Infectious Diseases, a component of the NIH, Department of Health and Human Services, under Contract HHSN272201800011C.