NCT04482595

BIO 300 Oral Suspension in Previously Hospitalized Long COVID Patients

A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Humanetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• COVID-19
• Long COVID
• Pulmonary Fibrosis
• Post-acute Respiratory Complications of COVID-19

Interventions

Type	Name	Description
DRUG	BIO 300 Oral Suspension	Suspension of genistein nanoparticles
DRUG	Placebo	Matched placebo for BIO 300 Oral Suspension

Timeline

• Start date: 2020-11-11
• Primary completion: 2024-07-31
• Completion: 2025-04-30
• First posted: 2020-07-22
• Last updated: 2024-10-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study