A Phase 2 Study of BIO 300 in Patients with COVID-19

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A Phase 2 Study of BIO 300 in Patients with COVID-19

Brief description of study

COVID-19 is caused by a virus that triggers inflammation of the lungs. This inflammation may damage the lungs and lead to scarring. This scarring causes the lungs to stiffen which makes it harder to breathe. This scarring may develop months after you have recovered from COVID-19. Currently, BIO 300 is being developed to protect normal lung tissue from radiation exposure. The active component in BIO 300 is genistein, which is naturally found in soy. It is thought that genistein can stop inflammation by binding proteins in the body that are normally bound by estrogen. Researchers believe that the study drug may also shield the lungs from the harmful effects of COVID-19. BIO 300 is considered an investigational drug because it is still undergoing testing and is not a Food and Drug Administration (FDA) approved treatment for lung damage caused by COVID-19. This research study will see if BIO 300 Oral Suspension (BIO 300), the study drug, helps improve the lung function of patients who were hospitalized with and have recovered from COVID-19.

Clinical Study Identifier: s20-00730

ClinicalTrials.gov Identifier: NCT04482595

Principal Investigator: Rany Condos.

Other Investigators: Daniel H. Sterman, John S Munger.

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