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BIO 300 Oral Suspension in Discharged COVID-19 Patients

Study Purpose

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 current background standard of care based on local clinical site practice.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥ 18. 2. 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) 3. Patients who met the criteria for COVID-19-related acute respiratory distress syndrome (ARDS) while hospitalized as defined by the following: 1. Acute onset (within 14 days of initial symptoms); and. 2. At least one of: invasive or non-invasive mechanical ventilation with a PaO2/FiO2 (or correlated SaO2/FiO2) < 300 mmHg with PEEP > 5 cm H2O, or high flow nasal oxygen (>70% O2) administered for ≥ 48 hours; and. 3. Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules; and. 4. Respiratory failure not fully explained by cardiac failure or fluid overload. 4. Radiographic signs of lung injury after standard treatment of COVID-19 such as, ground glass opacity, consolidation, or fibrotic shadows at screening. 5. Able to perform a PFT and have a DLCO <70% of predicted at screening. 6. Able to perform a 6-minute walk test. 7. Blood routine, liver and kidney function test values are within the controllable range. 1. Adequate hepatic function as evidenced by ALT, AST and LDH < 2X ULN and bilirubin < 1.5X ULN for the reference lab. 2. Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault Equation. 3. Adequate hematopoietic function as evidenced by white blood cells ≥ 3x10^9 / L and platelets ≥ 100x10^9 / L. 8. Female patients of childbearing potential must have a negative pregnancy test at screening. 9. 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. 10. Ability of the patient or the patient's legal representative to read and provide written informed consent.

Exclusion Criteria:

1. Severe background disease like severe cardiac or pulmonary insufficiency (WHO grade III or IV), severe liver and kidney diseases, severe COPD, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated. 2. Severe asthma on chronic therapy with biologics or steroids. 3. Prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages I or II) breast cancer. 4. D-dimer levels of >2,000 ng/mL at screening. 5. Use of anti-pulmonary fibrosis drugs (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) within 5 days of the first scheduled day of study intervention dosing. 6. Use of anti-cytokine release syndrome drugs (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) within 5 days of the first scheduled day of study intervention dosing. 7. Use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the first scheduled day of study intervention dosing. 8. An active infection or infection with a fever ≥ 38.5°C within 3 days of the first scheduled day of study intervention dosing. 9. Poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of Screening; history of congestive heart failure (NYHA Class III or IV); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker. 10. QTc with Fridericia's correction that is unmeasurable, or ≥480 msec on screening ECG. The average QTc from the screening ECG (completed in triplicate) must be <480 msec for the patient to be eligible for the study. 11. Patients taking any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes (www.crediblemeds.org) are not eligible if QTc ≥460 msec. 12. Patients who have undergone thoracotomy within 4 weeks of Day 1 of protocol therapy. 13. Patients that have a known allergy to any of the placebo components. 14. Psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy. 15. Pregnancy or currently on estrogen-based contraceptives. 16. Women who are breastfeeding. 17. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04482595
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Humanetics Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryOtherNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Fibrosis
Arms & Interventions

Arms

Experimental: BIO 300 Oral Suspension (genistein 1500 mg)

BIO 300 Oral Suspension (genistein 1500 mg) will be self-administered daily for 7 days each week for 12 weeks.

Placebo Comparator: Placebo

BIO 300 Oral Suspension matched placebo will be self-administered daily for 7 days each week for 12 weeks.

Interventions

Drug: - BIO 300 Oral Suspension

Suspension of genistein nanoparticles

Drug: - Placebo

Matched placebo for BIO 300 Oral Suspension

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Aurora, Colorado

Status

Recruiting

Address

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

Site Contact

Jeff McKeehan

jeffrey.mckeehan@cuanschutz.edu

303-724-6080

NYU Langone Health, New York, New York

Status

Recruiting

Address

NYU Langone Health

New York, New York, 10016

Site Contact

Raveena Vakil

raveena.vakil@nyulangone.org

212-263-8119

Houston Methodist Research Institute, Houston, Texas

Status

Not yet recruiting

Address

Houston Methodist Research Institute

Houston, Texas, 77210

Site Contact

Bela Jain, BSMT (ASCP), CCRP

bjain@houstonmethodist.org

281-485-3434