Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
Randomized, double-blinded, placebo-controlled, two-arm study to evaluate the effectiveness and safety of BIO 300 Oral Suspension (BIO 300) for the mitigation of impaired pulmonary function in 2019 Coronavirus Disease (COVID-19) patients recently discharged from the hospital. Patients will be randomized 1:1 to receive BIO 300 or placebo. All patients will receive the same background current standard of care.
Description: Diffusing capacity of the lungs for carbon monoxide (DLCO)
Measure: Change in DLCO Time: 12 WeeksDescription: 6 minute walk test (6MWT)
Measure: Change in 6 Minute Walk Test Time: 12 WeeksDescription: Diffusing capacity of the lungs for carbon monoxide (DLCO)
Measure: Change in DLCO Time: 6 Months and 12 MonthsDescription: 6 minute walk test (6MWT)
Measure: Change in 6 Minute Walk Test Time: 6 Months and 12 MonthsDescription: Forced vital capacity (FVC)
Measure: Change in FVC Time: 12 Weeks, 6 Months and 12 MonthsDescription: Forced expiratory volume in one second (FEV1)
Measure: Change in FEV1 Time: 12 Weeks, 6 Months and 12 MonthsDescription: Ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)
Measure: Change in FEV1/FVC Ratio Time: 12 Weeks, 6 Months and 12 MonthsDescription: Oxygen saturation (pulse oximetry) at rest and during the 6 minute walk test (6MWT)
Measure: Change in Pulse Oximetry at Rest and During the 6MWT Time: 12 Weeks, 6 Months and 12 MonthsDescription: Evidence of pulmonary fibrosis on computerized tomography (CT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis
Measure: Change in Pulmonary Fibrosis on CT Scan Time: 12 Weeks, 6 Months and 12 MonthsDescription: 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.
Measure: Change in St. George's Respiratory Questionnaire (SGRQ) Scores Time: 12 Weeks, 6 Months and 12 MonthsDescription: Monitoring of blood serum levels for alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) (all reported as Units/L)
Measure: Change in Clinical Laboratory Values for Serum Enzymes Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 MonthsDescription: Monitoring of blood serum levels for bilirubin, C-reactive protein (CRP), creatinine, blood urea nitrogen (BUN), cholesterol and triglycerides (all reported as mg/dL)
Measure: Change in Clinical Laboratory Values Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 MonthsDescription: Monitoring of blood serum levels for troponin T, d-dimer and ferritin (all reported as ng/mL)
Measure: Change in Clinical Laboratory Values Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 MonthsDescription: Monitoring of blood serum levels for albumin (g/dL)
Measure: Change in Clinical Laboratory Values for Albumin Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 MonthsDescription: Monitoring of white blood cell, red blood cell and platelet counts
Measure: Change in Complete Blood Counts with Differential Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 MonthsDescription: Mortality at 12 months after initiating treatment
Measure: All-Cause Mortality Time: 12 MonthsDescription: Incidence of hospitalization after initial discharge and initiating treatment
Measure: Incidence of Re-Hospitalization Time: 12 MonthsDescription: Evaluate the safety of BIO 300 Oral Suspension treatment
Measure: Adverse Events Related to BIO 300 Oral Suspension Time: 12 MonthsDescription: Duration of supplemental oxygen use
Measure: Change in Duration of Supplemental Oxygen Use Time: 12 Weeks, 6 Months and 12 MonthsDescription: Prescribed supplemental oxygen flow rate at night, rest and exertion
Measure: Change in Supplemental Oxygen Use Time: 12 Weeks, 6 Months and 12 MonthsDescription: Expression levels of serum-derived cytokines (IL-1b, IL-6, IL-8, TNFa, and TGFb1)
Measure: Change in Serum Cytokine Expression Time: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 MonthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports