The goal of this study is to evaluate the safety and efficacy of BIO 300 Oral Suspension to improve lung function in patients that were previously hospitalized with COVID-19 related pulmonary complications.
What Does the Study Involve?
Participants will self-administer the study treatment (BIO 300 or placebo) orally once per day for 12 weeks. During the treatment period, participants will attend a combination of in-person (weeks 4, 8 and 12) and telehealth (weeks 1, 2, 6, and 10) visits to monitor their lung function and overall health. Participants will attend two additional in-person follow-up visits at 6 and 12 months from the start of the treatment period.
Participants will monitor their lung function while at home using a spirometer and pulse oximeter that will be provided. Participants will complete additional lung function tests, routine blood work and a total of four chest CT scans during in-person visits to the clinic.
Who Can Participate?
To be eligible, candidates must:
- Be at least 18 years old
- Have been hospitalized due to COVID-19 related complications and are ready to be discharged, or were discharged within the past 365 days
- Have been diagnosed with (or met the criteria for) acute respiratory distress syndrome (ARDS) while hospitalized
- Be able to commute to one of the participating study centers (listed below) for in-person clinic visits
Where Is It Taking Place?
The following medical centers are currently enrolling patients into this study:
- New York University Langone Health (New York, NY)
- Houston Methodist Research Institute (Pearland, TX)
- Montefiore Medical Center (Bronx, NY)
- University of Texas Health Science Center at Houston (Houston, TX)
Is There a Cost?
There is no cost to participate in this study. No charges associated with medical procedures related to the study will be billed to the participant or their insurance.
Is Compensation Provided?
Participants will be provided a $50 stipend for each in-person clinic visit.
Number of Visits
Participants will participate in six in-person clinic visits (including the initial screening visit) over the course of the one-year study.
Visit ClinicalTrials.gov for details.
New York University – Langone (New York, NY)
Research Coordinator: Raveena Vakil
Houston Methodist Research Institute (Houston, TX)
Research Coordinator: Bela Jain
Montefiore Medical Center (Houston, TX)
Research Coordinator: Hiwet Tzehaie
University of Texas Health Science Center at Houston (Houston, TX)
Research Coordinator: MaryJane Keller, NP