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: 4

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

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.

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

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.

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+