BIO 300 Oral Suspension for Post-COVID Syndrome

Not currently recruiting at 4 trial locations

Overseen By Bela Patel, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Humanetics Corporation

Must not be taking: Anti-fibrosis, Anti-cytokine, Corticosteroids, others

Disqualifiers: Severe cardiac, Pulmonary, Liver, Kidney, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BIO 300 Oral Suspension, to determine if it can improve lung function in individuals hospitalized for severe COVID-19 and now experiencing ongoing lung issues known as Long-COVID. Participants will receive either BIO 300 or a placebo (a harmless pill resembling the medicine) to compare results. Suitable candidates for this trial include those who had severe COVID-19, were hospitalized, and continue to experience breathing difficulties or other lung problems after discharge. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications to join the trial?

The trial requires that you stop taking certain medications, such as anti-pulmonary fibrosis drugs, anti-cytokine release syndrome drugs, and systemic corticosteroids, at least 5 days before starting the study. If you are taking medications that may cause QTc prolongation, you may not be eligible if your QTc is too high. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that BIO 300 Oral Suspension is likely to be safe for humans?

Research has shown that BIO 300 Oral Suspension has been tested for safety in people. In studies with other patients, taking BIO 300 orally alongside standard treatments proved to be safe and well-tolerated. No serious side effects were directly linked to BIO 300. Regular health checks and blood tests ensured safety in these studies, demonstrating that BIO 300 is generally safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BIO 300 Oral Suspension for Post-COVID Syndrome because it introduces a novel approach by using genistein, a natural compound found in soy. Unlike standard treatments that primarily address specific symptoms of post-COVID syndrome, such as fatigue or respiratory issues, BIO 300 leverages the potential anti-inflammatory and antioxidant properties of genistein to target the condition more holistically. Additionally, its oral suspension form allows for easy daily administration, potentially improving patient compliance compared to more complex or invasive treatments.

What evidence suggests that BIO 300 Oral Suspension could be an effective treatment for post-COVID syndrome?

Research has shown that BIO 300 Oral Suspension, which participants in this trial may receive, might improve lung function in people with Long-COVID. In earlier studies, patients who took BIO 300 demonstrated better lung function and could exercise more easily compared to those who took a placebo, a harmless pill with no active ingredients. The treatment also appeared to enhance their overall quality of life. BIO 300 contains genistein, which acts on certain parts of the body that may aid in lung healing. These findings offer encouraging signs for helping those with ongoing lung problems after severe COVID-19. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can walk for 6 minutes without assistance.

My kidney function is within the normal range.

Your blood, liver, and kidney test results are normal.

Exclusion Criteria

Women who are breastfeeding

I had chest surgery less than 4 weeks ago.

Your heart's electrical activity, measured on a screening test, must be less than 480 milliseconds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BIO 300 Oral Suspension or placebo daily for 12 weeks

12 weeks

Weekly self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular monitoring at 4 weeks, 8 weeks, 12 weeks, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• BIO 300 Oral Suspension
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: BIO 300 Oral Suspension (genistein 1500 mg) Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Humanetics Corporation

Lead Sponsor

Trials

8

Recruited

300+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04482595

Study Details | NCT04482595 | BIO 300 Oral Suspension ... Patient reported outcome to measure impact on overall health, daily life, and perceived well-being in patients with impaired pulmonary function. Scores range ...

2. withpower.com withpower.com/trial/bio-300-oral-suspension-for-post-covid-syndrome-02050

BIO 300 Oral Suspension for Post-COVID Syndrome Trial Overview The study is testing BIO 300 Oral Suspension against a placebo in improving lung function in Long-COVID patients post-hospitalization. It's ...

3. uth.trialstoday.org uth.trialstoday.org/list/print/NCT04482595

BIO 300 Oral Suspension in Previously Hospitalized Long ... This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate the safety and efficacy of BIO 300 Oral Suspension (BIO 300) ...

4. biospace.com biospace.com/press-releases/humanetics-corporation-announces-positive-phase-2-clinical-trial-results-in-covid-19-study-aimed-at-improving-pulmonary-function

Humanetics Corporation Announces Positive Phase 2 ... The study compared the lung function, exercise capacity, and quality of life in COVID-19 survivors who received BIO 300 against a placebo group.

5. redjournal.org redjournal.org/article/S0360-3016(23)07845-8/fulltext

Multicenter Phase 1b/2a Clinical Trial of Radioprotectant ... Genistein-aglycone bioavailability after BIO 300 dosing surpasses the predicted half maximal effective concentration (EC50) for ERβ, 24 ng ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06741345

NCT06741345 | Phase 1 BIO 300 Oral Suspension Blood samples and health checks will be done throughout the study to assess safety, drug is absorption and distribution in the body (PK), and its effects (PD).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8398080/

Lung Fibrosis after COVID-19: Treatment Prospects - PMC In this review, we analyze the latest data from ongoing clinical trials aimed at treating post-COVID lung fibrosis and analyze the rationale for the current ...