BIO 300 Oral Suspension in Previously Hospitalized Long COVID Patients

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04482595
• Other study ID #: CL0105-01
• Secondary ID: 272201800011C-P0
• Status: Recruiting
• Phase: Phase 2
• Start date: November 11, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Humanetics Corporation
• Contact: Michael D Kaytor, Ph.D.
• Phone: 952-400-0405
• Email: mkaytor[@]humaneticscorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Radiographic signs of lung injury after standard treatment of COVID-19 such as, ground glass opacity, consolidation, or fibrotic shadows at screening

4. Able to perform a PFT and have a DLCO <70% of predicted at screening

5. Able to perform a 6-minute walk test

6. 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

7. Female patients of childbearing potential must have a negative pregnancy test at screening

8. 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

9. 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.

Related Conditions & MeSH terms

• COVID-19
• Long COVID
• Pulmonary Fibrosis

Intervention

Drug:
• BIO 300 Oral Suspension
Suspension of genistein nanoparticles
• Placebo
Matched placebo for BIO 300 Oral Suspension

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Houston Methodist Research Institute	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	NYU Langone Health	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Humanetics Corporation	National Institute of Allergy and Infectious Diseases (NIAID), NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Supplemental Oxygen Use	Prescribed supplemental oxygen flow rate at night, rest and exertion	12 Weeks, 6 Months and 12 Months
Other	Change in Duration of Supplemental Oxygen Use	Duration of supplemental oxygen use	12 Weeks, 6 Months and 12 Months
Other	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
Primary	Change in DLCO	Diffusing capacity of the lungs for carbon monoxide (DLCO)	12 Weeks
Secondary	Change in 6 Minute Walk Test	6 minute walk test (6MWT)	12 Weeks
Secondary	Change in FVC	Forced vital capacity (FVC)	12 Weeks, 6 Months and 12 Months
Secondary	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
Secondary	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
Secondary	Incidence of Re-Hospitalization	Incidence of hospitalization after initial discharge and initiating treatment	12 Months
Secondary	All-Cause Mortality	Mortality at 12 months after initiating treatment	12 Months
Secondary	Change in FEV1	Forced expiratory volume in one second (FEV1)	12 Weeks, 6 Months and 12 Months
Secondary	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
Secondary	Change in 6 Minute Walk Test	6 minute walk test (6MWT)	6 Months and 12 Months
Secondary	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
Secondary	Change in DLCO	Diffusing capacity of the lungs for carbon monoxide (DLCO)	6 Months and 12 Months
Secondary	Adverse Events Related to BIO 300 Oral Suspension	Evaluate the safety of BIO 300 Oral Suspension treatment	12 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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