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

NCT04742725 | Completed Phase 2 FDA Drug

• 1 other identifier: TAL-PRO-001
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief 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. 1.US Patent No. RE 42,645
2. 2.Japanese Patent No. 5601745
3. 3.European Patent No. 1556023
4. 4.Canadian Patent No. 2539567
5. 5.Australian Patent No. 2010201136
6. 6.Protective Metallothionein Analog Compounds, Their Compositions and Use Thereof in the Treatment of Pathogenic Disease:
7. 7.Canadian Patent No. 2963131
8. 8.Australian Patent No. 2018279015

Conditions

Coronavirus Disease 2019 (COVID-19)

Keywords

COVID-19, Prothione

Outcome Measures

Primary Outcomes (1)

• Time (days) to successful clinical recovery from positive RT-PCR for SARS-COV2 as indicated by two consecutive negative RT-PCR tests measured with three different measurements within a 24-36 hour period.

  24-36 hour period

Secondary Outcomes (7)

• Change from Baseline to Day 29 in Serum 8-OHdG levels

  Baseline to day 29

• Change in RBC intracellular Glutathione levels to Day 29

  Baseline to day 29

• Quantitative change from Baseline (Screening Visit) to Day 29 oropharyngeal cell intracellular GSH levels

  Baseline to day 29

• Time to clinical resolution (TTCR) defined as the time (days) from initiation of study treatment until reach a score of 0 at least in three of the following: o Fever o Myalgia o Dyspnea o Cough

  Baseline to day 29

• Evaluate Cycle Threshold (Ct) numbers used in qualitative and quantitative RT-PCR for SARS-COV2 tests.

  Baseline to day 29

Other Outcomes (21)

• Quantitative changes in viral load from baseline (Screening Visit) to Day 29.

  Baseline to day 29

• Change from baseline to Day 29 in pulse oxygen saturation (SpO2)

  Baseline to day 29

• Change from baseline to Day 29 in Quantitative C-Reactive Protein level

  Baseline to Day 29

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Prothione ™

EXPERIMENTAL

Drug: Prothione™ (6g)

Interventions

Placebo DRUG

Placebo

Placebo

Prothione™ (6g) DRUG

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

Prothione ™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects are required to meet all of the following criteria for enrollment into the study:
• Male or female adult ≥ 18 years of age at time of enrollment with mild to moderate symptoms caused by coronavirus 2019 confirmed infection with COVID-19 by PCR and one or more of the following:
• Mild (uncomplicated) Illness:
• Diagnosed with COVID-19 by a standardized RT-PCR assay AND
• Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
• No signs of a more serious lower airway disease AND RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
• Moderate Illness:
• Diagnosed with COVID-19 by a standardized RT-PCR assay AND
• In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
• Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
• If available, lung infiltrates based on X-ray or CT scan \< 50% present
• Subjects with normal level of Vitamin B2; Note: If the result was below the normal range, based on clinical judgment by physician, appropriate treatment to be added to the subject treatment regimen as per standard of care. A B complex daily supplement will be supplied, if needed.
• Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures;
• Understands and agrees to comply with planned study procedures; and
• Negative pregnancy test for female subjects. Women of child-bearing potential (WOCBP) and Women not of child-bearing potential are eligible to participate. Both women of child-bearing potential and women of no child-bearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study (and for 30 days after taking the last dose of Prothione™ ).

You may not qualify if:

• Potential subjects meeting any of the following criteria will be excluded from enrollment:
• Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening;
• Subjects who have history of receiving NAC, Prothione™ Capsules or GSH supplements in the past 30 days before the screening visit;
• Subjects who have history of receiving corticosteroids (topical corticosteroid is excluded) in the past 30 days;
• Subjects who are currently receiving Chemotherapy or Immunotherapy for the treatment of cancer;
• Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU);
• Subject with active Hepatitis B and Hepatitis C;
• Subjects who are participating in other clinical trials;
• Subjects that have had any Covid19 Vaccination;
• Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Prothione™ are not eligible;
• Inability to provide informed consent or to comply with study requirements; and
• Subjects who are pregnant or breast-feeding.

Sponsors & Collaborators

• Prothione, LLC: lead

Study Sites (1)

Rinda Ubuzima

Kigali, Rwanda

Location

MeSH Terms

Conditions

COVID-19

Interventions

Prothione

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laura Lile, MD,RPh

  Innate FFAAP Medicines, L.L.C.

  PRINCIPAL INVESTIGATOR

• Vincent Mutabazi, MD

  Research, Epidemiology and Training Programs: RASD Rwanda

  PRINCIPAL INVESTIGATOR

• Albert Crum, MD

  Innate FFAAP Medicines, L.L.C.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: May 25, 2021
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

RW (1)