BIO 300 Oral Suspension for Post-COVID Syndrome

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: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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 am 18 years old or older.

I can walk for 6 minutes without assistance.

My kidney function is within the normal range.

Exclusion Criteria

Women who are breastfeeding

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.

Treatment Details

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.

Participant Groups

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+