COVID-19Phase 2NCT04482595
BIO 300 Oral Suspension in Previously Hospitalized Long COVID Patients
A Phase 2 study testing BIO 300 Oral Suspension in people with COVID-19 and Long COVID, run by Humanetics Corporation at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Long COVID, Pulmonary Fibrosis
- What is being tested?
- BIO 300 Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Nov 2020to 30 Apr 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- Adequate hepatic function as evidenced by ALT, AST and LDH < 2X ULN and bilirubin < 1.5X ULN for the reference lab
- 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
- Adequate hematopoietic function as evidenced by white blood cells ≥ 3x10^9 / L and platelets ≥ 100x10^9 / L
- 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
Who cannot join
- 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
- Severe asthma on chronic therapy with biologics or steroids.
- 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
- D-dimer levels of >2,000 ng/mL at screening
- 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
- 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
Show all 17Show fewer
- Use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the first scheduled day of study intervention dosing
- An active infection or infection with a fever ≥ 38.5°C within 3 days of the first scheduled day of study intervention dosing
- 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
- 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
- Patients taking any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes (www.crediblemeds.org) are not eligible if QTc ≥460 msec
- Patients who have undergone thoracotomy within 4 weeks of Day 1 of protocol therapy
- Patients that have a known allergy to any of the placebo components
- 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
- Pregnancy or currently on estrogen-based contraceptives
- Women who are breastfeeding
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Houston Methodist Research Institute
Houston, Texas, 77210
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients
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.
- Conditions
- COVID-19, Long COVID, Pulmonary Fibrosis, Post-acute Respiratory Complications of COVID-19
- Being tested
- BIO 300 Oral Suspension, Placebo
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO 300 Oral SuspensionDrug
Suspension of genistein nanoparticles
PlaceboDrug
Matched placebo for BIO 300 Oral Suspension
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BIO 300 Oral Suspension |
| Placebo | Placebo comparator | BIO 300 Oral Suspension matched placebo will be self-administered daily for 7 days each week for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DLCO
Diffusing capacity of the lungs for carbon monoxide (DLCO)
Measured: 12 Weeks
Secondary outcomes (17)
Change in 6 Minute Walk Test
6 minute walk test (6MWT)
Measured: 12 Weeks
Change in FVC
Forced vital capacity (FVC)
Measured: 12 Weeks, 6 Months and 12 Months
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.
Measured: 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
Measured: 12 Weeks, 6 Months and 12 Months
Incidence of Re-Hospitalization
Incidence of hospitalization after initial discharge and initiating treatment
Measured: 12 Months
All-Cause Mortality
Mortality at 12 months after initiating treatment
Measured: 12 Months
Change in FEV1
Forced expiratory volume in one second (FEV1)
Measured: 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)
Measured: 12 Weeks, 6 Months and 12 Months
Change in 6 Minute Walk Test
6 minute walk test (6MWT)
Measured: 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)
Measured: 12 Weeks, 6 Months and 12 Months
Change in DLCO
Diffusing capacity of the lungs for carbon monoxide (DLCO)
Measured: 6 Months and 12 Months
Adverse Events Related to BIO 300 Oral Suspension
Evaluate the safety of BIO 300 Oral Suspension treatment
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start11 Nov 2020
- Primary completion31 Jul 2024
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482595
- Sponsor's protocol ID
- CL0105-01
- Other IDs
- 272201800011C-P00005-9999-1
- Status last verified
- Feb 2024
- First submitted
- 17 Jul 2020
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No