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

NCT04742725 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2022-04-21

No results posted yet for this study

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

Conditions

  • Coronavirus Disease 2019 (COVID-19)

Interventions

DRUG

Placebo

Placebo

DRUG

Prothione™ (6g)

Prothione is a pro-Glutathione compound includes free-form amino acids

Sponsors & Collaborators

  • Prothione, LLC

    lead OTHER

Principal Investigators

  • Laura Lile, MD,RPh · Innate FFAAP Medicines, L.L.C.

  • Vincent Mutabazi, MD · Research, Epidemiology and Training Programs: RASD Rwanda

  • Albert Crum, MD · Innate FFAAP Medicines, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2021-09-21
Completion
2021-09-21
FDA Drug
Yes

Countries

  • Rwanda

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742725 on ClinicalTrials.gov