This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate the safety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lung function in patients that were hospitalized for severe COVID-19-related illness and continue to experience post-acute respiratory complications associated with Long-COVID after discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Suspension of genistein nanoparticles
Matched placebo for BIO 300 Oral Suspension
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
NYU Langone Health
New York, New York, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Change in DLCO
Diffusing capacity of the lungs for carbon monoxide (DLCO)
Time frame: 12 Weeks
Change in 6 Minute Walk Test
6 minute walk test (6MWT)
Time frame: 12 Weeks
Change in FVC
Forced vital capacity (FVC)
Time frame: 12 Weeks, 6 Months and 12 Months
Change in St. George's Respiratory Questionnaire (SGRQ) Scores
Patient reported outcome to measure impact on overall health, daily life, and perceived well-being in patients with impaired pulmonary function. Scores range from 0-100 with higher scores indicating more limitations.
Time frame: 12 Weeks, 6 Months and 12 Months
Change in Pulmonary Fibrosis on HRCT Scan
Evidence of pulmonary fibrosis on high resolution computerized tomography (HRCT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis
Time frame: 12 Weeks, 6 Months and 12 Months
Incidence of Re-Hospitalization
Incidence of hospitalization after initial discharge and initiating treatment
Time frame: 12 Months
All-Cause Mortality
Mortality at 12 months after initiating treatment
Time frame: 12 Months
Change in FEV1
Forced expiratory volume in one second (FEV1)
Time frame: 12 Weeks, 6 Months and 12 Months
Change in FEV1/FVC Ratio
Ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)
Time frame: 12 Weeks, 6 Months and 12 Months
Change in 6 Minute Walk Test
6 minute walk test (6MWT)
Time frame: 6 Months and 12 Months
Change in Pulse Oximetry at Rest and During the 6MWT
Oxygen saturation (pulse oximetry) at rest and during the 6 minute walk test (6MWT)
Time frame: 12 Weeks, 6 Months and 12 Months
Change in DLCO
Diffusing capacity of the lungs for carbon monoxide (DLCO)
Time frame: 6 Months and 12 Months
Adverse Events Related to BIO 300 Oral Suspension
Evaluate the safety of BIO 300 Oral Suspension treatment
Time frame: 12 Months
Change in Clinical Laboratory Values
Monitoring of blood serum levels for bilirubin, C-reactive protein (CRP), creatinine, blood urea nitrogen (BUN), cholesterol and triglycerides (all reported as mg/dL)
Time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
Change in Clinical Laboratory Values
Monitoring of blood serum levels for troponin T, d-dimer and ferritin (all reported as ng/mL)
Time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
Change in Clinical Laboratory Values for Albumin
Monitoring of blood serum levels for albumin (g/dL)
Time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
Change in Clinical Laboratory Values for Serum Enzymes
Monitoring of blood serum levels for alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) (all reported as Units/L)
Time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
Change in Complete Blood Counts with Differential
Monitoring of white blood cell, red blood cell and platelet counts
Time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.