CovidResearchTrials by Shray Alag

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BIO 300 Oral SuspensionWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D011658 Pulmonary Fibrosis NIH 0.38

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002206 Pulmonary fibrosis HPO 0.38

There is one clinical trial.

Clinical Trials

1 A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients

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.

NCT04482595 Pulmonary Fibrosis Drug: BIO 300 Oral Suspension Drug: Placebo
MeSH:Pulmonary Fibrosis
HPO:Pulmonary fibrosis

Primary Outcomes

Description: Diffusing capacity of the lungs for carbon monoxide (DLCO)

Measure: Change in DLCO

Time: 12 Weeks

Description: 6 minute walk test (6MWT)

Measure: Change in 6 Minute Walk Test

Time: 12 Weeks

Secondary Outcomes

Description: Diffusing capacity of the lungs for carbon monoxide (DLCO)

Measure: Change in DLCO

Time: 6 Months and 12 Months

Description: 6 minute walk test (6MWT)

Measure: Change in 6 Minute Walk Test

Time: 6 Months and 12 Months

Description: Forced vital capacity (FVC)

Measure: Change in FVC

Time: 12 Weeks, 6 Months and 12 Months

Description: Forced expiratory volume in one second (FEV1)

Measure: Change in FEV1

Time: 12 Weeks, 6 Months and 12 Months

Description: 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 Months

Description: 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 Months

Description: 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 Months

Description: 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 Months

Description: 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 Months

Description: 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 Months

Description: 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 Months

Description: 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 Months

Description: 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 Months

Description: Mortality at 12 months after initiating treatment

Measure: All-Cause Mortality

Time: 12 Months

Description: Incidence of hospitalization after initial discharge and initiating treatment

Measure: Incidence of Re-Hospitalization

Time: 12 Months

Description: Evaluate the safety of BIO 300 Oral Suspension treatment

Measure: Adverse Events Related to BIO 300 Oral Suspension

Time: 12 Months

Other Outcomes

Description: Duration of supplemental oxygen use

Measure: Change in Duration of Supplemental Oxygen Use

Time: 12 Weeks, 6 Months and 12 Months

Description: Prescribed supplemental oxygen flow rate at night, rest and exertion

Measure: Change in Supplemental Oxygen Use

Time: 12 Weeks, 6 Months and 12 Months

Description: 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 Months

Related HPO nodes (Using clinical trials)

HP:0002206: Pulmonary fibrosis
Genes 80
SFTPA2 NKX2-1 BMP15 TERT HPS4 IRF5 ALMS1 TINF2 PARN TERT TERT FSHR CAV1 CCN2 IRF5 TINF2 FASLG SP110 SFTPC ABCA3 KIAA0319L CASP10 CTLA4 FAS THOC2 BNC1 PARN TERC TERC CAV1 SFTPC RASGRP1 SFTPA1 TERC NOP10 RNF168 HLA-DRB1 SPIDR CLCA4 RNF168 POLR3H FAM13A STN1 PSMC3IP DSP RTEL1 HLA-DRB1 NHP2 MUC5B TERT NR5A1 CCR6 RTEL1 SFTPA2 DKC1 DCTN4 FAS CCR6 PLEC BTNL2 HLA-DPB1 MRPS22 HLA-DPA1 PTPN22 RCBTB1 CFTR PRKCD TERT ATP11A TGFB1 DPP9 CCN2 MUC5B NUP107 FAM111B PRTN3 AP3B1 HPS1 STX1A HLA-DRB1
Protein Mutations 1
V600E
SNP 4
rs35705950 rs3570920 rs3750920 rs6971