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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
Must not have
Pregnancy or currently on estrogen-based contraceptives
Use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the first scheduled day of study intervention dosing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am pregnant or using estrogen-based birth control.
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I haven't taken any systemic corticosteroids like prednisone within the last 5 days.
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I do not have severe ongoing health issues like uncontrolled blood pressure, recent heart problems, or poorly managed diabetes.
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I do not have severe heart, lung, liver, kidney diseases, severe COPD, serious neurological conditions, or any other cancer being treated.
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My heart's electrical cycle is normal and I'm not on medication that could disrupt it.
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I have not had a fever or serious infection in the last 3 days.
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I have severe asthma and am on long-term biologic or steroid treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks, 8 weeks, 12 weeks, 6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Adverse Events Related to BIO 300 Oral Suspension
All-Cause Mortality
Change in 6 Minute Walk Test
+12 more
Other study objectives
Change in Duration of Supplemental Oxygen Use
Cytokine
Change in Supplemental Oxygen Use

Side effects data

From 2020 Phase 1 & 2 trial • 21 Patients • NCT02567799
43%
Neutrophil Count Decreased
29%
Dyspepsia
29%
Fatigue
29%
Diarrhea
29%
Anorexia
29%
Constipation
29%
Dysphagia
29%
Platelet Count Decreased
29%
Edema Limbs
14%
Dry Cough
14%
Dizziness
14%
Dyspnea
14%
Pneumonitis
14%
Hypotension
14%
Cardiac Arrest
14%
Thromboembolic Event
14%
Hypokalemia
14%
Hypomagnesemia
14%
Thrombosis
14%
Lower Respiratory Tract Infection/Pneumonia
14%
Epistaxis
14%
Flatulence
14%
White Blood Cell Decreased
14%
Hypomagnesemi
14%
Back Pain
14%
Radiation Dermatitis
14%
Anemia
14%
Hyponatremia
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
1,397 Previous Clinical Trials
861,792 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,302 Previous Clinical Trials
5,501,392 Total Patients Enrolled
Humanetics CorporationLead Sponsor
6 Previous Clinical Trials
195 Total Patients Enrolled

Media Library

BIO 300 Oral Suspension (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04482595 — Phase 2
Coronavirus Research Study Groups: BIO 300 Oral Suspension (genistein 1500 mg), Placebo
Coronavirus Clinical Trial 2023: BIO 300 Oral Suspension Highlights & Side Effects. Trial Name: NCT04482595 — Phase 2
BIO 300 Oral Suspension (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04482595 — Phase 2
~10 spots leftby Sep 2025
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