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| ID | Type | Description | Link |
|---|---|---|---|
| 272201800011C-P00005-9999-1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIO 300 Oral Suspension (genistein 1500 mg) | Experimental | BIO 300 Oral Suspension (genistein 1500 mg) will be self-administered daily for 7 days each week for 12 weeks. |
|
| Placebo | Placebo Comparator | BIO 300 Oral Suspension matched placebo will be self-administered daily for 7 days each week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIO 300 Oral Suspension | Drug | Suspension of genistein nanoparticles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in DLCO | Diffusing capacity of the lungs for carbon monoxide (DLCO) | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 Minute Walk Test | 6 minute walk test (6MWT) | 12 Weeks |
| Change in FVC | Forced vital capacity (FVC) | 12 Weeks, 6 Months and 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Supplemental Oxygen Use | Prescribed supplemental oxygen flow rate at night, rest and exertion | 12 Weeks, 6 Months and 12 Months |
| Change in Duration of Supplemental Oxygen Use | Duration of supplemental oxygen use |
Inclusion Criteria:
Age ≥ 18
Patients hospitalized for COVID-19-related complications ready to be discharged and those within 365 days of discharge (even if the patient was referred to subacute or acute respiratory rehabilitation after discharge)
Radiographic signs of lung injury after standard treatment of COVID-19 such as, ground glass opacity, consolidation, or fibrotic shadows at screening
Able to perform a PFT and have a DLCO <70% of predicted at screening
Able to perform a 6-minute walk test
Blood routine, liver and kidney function test values are within the controllable range
Female patients of childbearing potential must have a negative pregnancy test at screening
Female patients of childbearing potential and male participants with female sexual partners of childbearing potential must agree to use an effective method of non-estrogen-based contraception (e.g., condom and a diaphragm, condom and intrauterine device, condom and Depo-Provera, condom and Nexplanon, or condom and progesterone mini-pill) during the 12-week portion of the study that they are receiving study medication and for 30 days following the last dose of study medication, or to abstain from sexual intercourse during these time periods. Women who have been off estrogen contraceptives for a minimum of 5 days prior to the first scheduled day of study intervention dosing are eligible. A woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post-menopausal, defined as no menstrual periods for 12 consecutive months
Ability of the patient or the patient's legal representative to read and provide written informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| NYU Langone Health |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Randomized, placebo-controlled
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| Placebo | Drug | Matched placebo for BIO 300 Oral Suspension |
|
| 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. | 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 | 12 Weeks, 6 Months and 12 Months |
| Incidence of Re-Hospitalization | Incidence of hospitalization after initial discharge and initiating treatment | 12 Months |
| All-Cause Mortality | Mortality at 12 months after initiating treatment | 12 Months |
| Change in FEV1 | Forced expiratory volume in one second (FEV1) | 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) | 12 Weeks, 6 Months and 12 Months |
| Change in 6 Minute Walk Test | 6 minute walk test (6MWT) | 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) | 12 Weeks, 6 Months and 12 Months |
| Change in DLCO | Diffusing capacity of the lungs for carbon monoxide (DLCO) | 6 Months and 12 Months |
| Adverse Events Related to BIO 300 Oral Suspension | Evaluate the safety of BIO 300 Oral Suspension treatment | 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) | 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) | 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) | 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) | 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 | 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months |
| 12 Weeks, 6 Months and 12 Months |
| Change in Serum Cytokine Expression | Expression levels of serum-derived cytokines (IL-1b, IL-6, IL-8, TNFa, and TGFb1) | 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months |
| New York |
| New York |
| 10016 |
| United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77210 | United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017563 | Lung Diseases, Interstitial |
| D005355 | Fibrosis |