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)
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Sponsor
- Prothione, LLC
- Enrollment
- 231
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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:
-
US Patent No. RE 42,645
-
Japanese Patent No. 5601745
-
European Patent No. 1556023
-
Canadian Patent No. 2539567
-
Australian Patent No. 2010201136
• Protective Metallothionein Analog Compounds, Their Compositions and Use
Thereof in the Treatment of Pathogenic Disease:
-
Canadian Patent No. 2963131
-
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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;
Arms & Interventions
Placebo
Intervention: Placebo
Prothione ™
Intervention: Prothione™ (6g)
Outcomes
Primary Outcomes
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.
Time Frame: 24-36 hour period
Secondary Outcomes
- 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)
- Evaluate Cycle Threshold (Ct) numbers used in qualitative and quantitative RT-PCR for SARS-COV2 tests.(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)
- Quantitative change from Baseline (Screening Visit) to Day 29 oropharyngeal cell intracellular GSH levels(Baseline to day 29)
- Mortality at Day 29(Day 29)
- Clinical Improvement as assessed by change in symptom score from baseline (for fever, myalgia, dyspnea and cough).(Baseline to day 29)