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BIO 300 Oral Suspension for Post-COVID Syndrome
Phase 2
Recruiting
Research Sponsored by Humanetics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18
Able to perform a 6-minute walk test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months
Awards & highlights
Study Summary
This trial is testing whether BIO 300 Oral Suspension can improve lung function in patients who were hospitalized for severe COVID-19 and continue to experience post-acute respiratory complications. Patients will be randomly assigned to receive either BIO 300 or a placebo.
Who is the study for?
This trial is for adults who were hospitalized with severe COVID-19 and are now experiencing long-term lung issues. They must be able to perform certain physical tests, have specific lung damage signs, and their organ functions should be within safe ranges. Women of childbearing age need a negative pregnancy test and agree to non-estrogen-based contraception or abstinence.Check my eligibility
What is being tested?
The study is testing BIO 300 Oral Suspension against a placebo in improving lung function in Long-COVID patients post-hospitalization. It's randomized (patients are put into groups by chance), double-blinded (neither the researchers nor participants know who gets what treatment), and placebo-controlled.See study design
What are the potential side effects?
While the side effects of BIO 300 aren't specified here, typical oral medication side effects can include gastrointestinal discomfort, allergic reactions, headaches, dizziness, or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can walk for 6 minutes without assistance.
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My kidney function is within the normal range.
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I am a woman who can have children and my pregnancy test was negative.
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My lung scans show damage from COVID-19 treatment.
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My lung function test shows a DLCO less than 70% of what's expected.
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My liver tests are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks, 8 weeks, 12 weeks, 6 months and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Adverse Events Related to BIO 300 Oral Suspension
All-Cause Mortality
Change in 6 Minute Walk Test
+12 moreOther outcome measures
Change in Duration of Supplemental Oxygen Use
Cytokine
Change in Supplemental Oxygen Use
Side effects data
From 2020 Phase 1 & 2 trial • 21 Patients • NCT0256779943%
Neutrophil Count Decreased
29%
Diarrhea
29%
Dysphagia
29%
Platelet Count Decreased
29%
Dyspepsia
29%
Constipation
29%
Edema Limbs
29%
Fatigue
29%
Anorexia
14%
Dry Cough
14%
Hypotension
14%
Hyponatremia
14%
Flatulence
14%
White Blood Cell Decreased
14%
Lower Respiratory Tract Infection/Pneumonia
14%
Epistaxis
14%
Thrombosis
14%
Cardiac Arrest
14%
Thromboembolic Event
14%
Hypomagnesemia
14%
Pneumonitis
14%
Dyspnea
14%
Hypokalemia
14%
Dizziness
14%
Back Pain
14%
Radiation Dermatitis
14%
Anemia
14%
Hypomagnesemi
100%
80%
60%
40%
20%
0%
Study treatment Arm
BIO 300 Oral Suspension (500 mg/Day)
BIO 300 Oral Suspension (1000 mg/Day)
BIO 300 Oral Suspension (1500 mg/Day)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BIO 300 Oral Suspension (genistein 1500 mg)Experimental Treatment1 Intervention
BIO 300 Oral Suspension (genistein 1500 mg) will be self-administered daily for 7 days each week for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
BIO 300 Oral Suspension matched placebo will be self-administered daily for 7 days each week for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIO 300 Oral Suspension
2015
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
NYU Langone HealthOTHER
1,368 Previous Clinical Trials
839,676 Total Patients Enrolled
18 Trials studying COVID-19
58,512 Patients Enrolled for COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,419 Total Patients Enrolled
78 Trials studying COVID-19
292,158 Patients Enrolled for COVID-19
Humanetics CorporationLead Sponsor
6 Previous Clinical Trials
195 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity, measured on a screening test, must be less than 480 milliseconds.I had chest surgery less than 4 weeks ago.You have mental health, social, or substance abuse issues that would make it hard for you to follow the study's rules and treatment plan.I am pregnant or using estrogen-based birth control.I am 18 years old or older.I haven't taken any systemic corticosteroids like prednisone within the last 5 days.I can walk for 6 minutes without assistance.My kidney function is within the normal range.I haven't taken any lung fibrosis treatments in the last 5 days.Your blood, liver, and kidney test results are normal.I agree to use non-estrogen birth control or not have sex during the study.I do not have severe ongoing health issues like uncontrolled blood pressure, recent heart problems, or poorly managed diabetes.I have had cancer before and received chest radiation, except for early breast cancer treatment.I do not have severe heart, lung, liver, kidney diseases, severe COPD, serious neurological conditions, or any other cancer being treated.Your D-dimer levels are higher than 2,000 ng/mL during screening.My heart's electrical cycle is normal and I'm not on medication that could disrupt it.I am a woman who can have children and my pregnancy test was negative.I have not had a fever or serious infection in the last 3 days.My lung scans show damage from COVID-19 treatment.I was hospitalized for COVID-19 but am now ready to be discharged or was discharged within the last year.I have severe asthma and am on long-term biologic or steroid treatment.My lung function test shows a DLCO less than 70% of what's expected.You have enough white blood cells and platelets in your blood.I haven't taken any drugs for cytokine release syndrome in the last 5 days.My liver tests are within normal limits.
Research Study Groups:
This trial has the following groups:- Group 1: BIO 300 Oral Suspension (genistein 1500 mg)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any reports of adverse effects from taking BIO 300 Oral Suspension?
"BIO 300 Oral Suspension received a score of 2 for safety. This is due to the lack of efficacy data, as this is only a Phase 2 trial."
Answered by AI
Is this a unique clinical trial?
"At this time, there are 2 ongoing trials for BIO 300 Oral Suspension in 5 different locations. The first clinical trial began in 2017 and completed its Phase 2 approval stage that same year. The study, which was sponsored by DSM Nutritional Products, Inc., included 44 patients. Since then, 18254 other studies have been completed."
Answered by AI
What are the most similar investigations to the BIO 300 Oral Suspension research project?
"Currently, there are 2 ongoing clinical trials studying BIO 300 Oral Suspension. 0 of those live clinical trials are in Phase 3. Although the many trials for BIO 300 Oral Suspension are based in Atlanta, Georgia, there are a total of 8 locations running trials for this treatment."
Answered by AI
What oral suspension is BIO 300 used for most frequently?
"BIO 300 Oral Suspension is frequently used to treat osteomalacia, as well as other disorders like vitamin d deficiency, calcium deficiency, and osteodystrophy."
Answered by AI
How many study participants are involved in this research?
"That is correct. The online clinicaltrials.gov database show that this trial, which was originally posted on November 11th 2020, is still looking for participants. They need 66 patients from 4 different medical centres."
Answered by AI
Who else is applying?
What site did they apply to?
Houston Methodist Research Institute
University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- University of Texas Health Science Center at Houston: < 48 hours
Average response time
- < 2 Days
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