NCT04742725

A Study to Evaluate the Efficacy and Safety of Prothione™ Capsules for Mild to Moderate Coronavirus Disease 2019 (COVID-19)

A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Prothione™ Capsules for Mild to Moderate Coronavirus Disease 2019 (COVID-19)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Prothione, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a phase 2 proof of concept study. The purpose of this study is to assess the efficacy and safety of Prothione™ capsules administered orally twice a day for 30 days in subjects with mild to moderate COVID-19. The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period. The issued patents relevant to Prothione™ capsules and the treatment of viral disease include: • Nutritional or Therapeutic Compositions and Methods to Increase Bodily Glutathione Levels: 1. US Patent No. RE 42,645 2. Japanese Patent No. 5601745 3. European Patent No. 1556023 4. Canadian Patent No. 2539567 5. Australian Patent No. 2010201136 • Protective Metallothionein Analog Compounds, Their Compositions and Use Thereof in the Treatment of Pathogenic Disease: 6. Canadian Patent No. 2963131 7. Australian Patent No. 2018279015

Detailed description

This is a Phase 2, proof of concept, two-arm, randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of Prothione™ capsules in subjects with mild-to-moderate symptoms caused by coronavirus 2019 (COVID-19) infection. Subjects will be randomized to receive three Prothione™ capsules, or placebo orally administered twice daily (BID). The study will have three phases: screening period, treatment period, and follow-up period. Screening period is up to 3 days , the treatment period is 30 days and the follow-up period is 7 days after the last dose.Total study duration is up to 40 days.

Conditions

• Coronavirus Disease 2019 (COVID-19)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	Prothione™ (6g)	Prothione is a pro-Glutathione compound includes free-form amino acids

Timeline

• Start date: 2021-05-25
• Primary completion: 2021-09-21
• Completion: 2021-09-21
• First posted: 2021-02-08
• Last updated: 2022-04-21

Locations

1 site across 1 country: Rwanda

Regulatory

• FDA-regulated drug study