Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04742725
Other study ID # TAL-PRO-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 25, 2021
Est. completion date September 21, 2021

Study information

Verified date April 2022
Source Prothione, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 231
Est. completion date September 21, 2021
Est. primary completion date September 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study: 1. 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 2. 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. 3. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures; 4. Understands and agrees to comply with planned study procedures; and 5. 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™ ). Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only), female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile or 2 years post-menopausal. All male subjects/partners must agree to consistently and correctly use a condom for the duration of the study. In addition, subjects may not donate sperm for the duration of the study and for 30 days after taking study drug. Exclusion Criteria: Potential subjects meeting any of the following criteria will be excluded from enrollment: 1. Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening; 2. Subjects who have history of receiving NAC, Prothione™ Capsules or GSH supplements in the past 30 days before the screening visit; 3. Subjects who have history of receiving corticosteroids (topical corticosteroid is excluded) in the past 30 days; 4. Subjects who are currently receiving Chemotherapy or Immunotherapy for the treatment of cancer; 5. Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); 6. Subject with active Hepatitis B and Hepatitis C; 7. Subjects who are participating in other clinical trials; 8. Subjects that have had any Covid19 Vaccination; 9. Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Prothione™ are not eligible; 10. Inability to provide informed consent or to comply with study requirements; and 11. Subjects who are pregnant or breast-feeding.

Study Design


Intervention

Drug:
Placebo
Placebo
Prothione™ (6g)
Prothione is a pro-Glutathione compound includes free-form amino acids

Locations

Country Name City State
Rwanda Rinda Ubuzima Kigali

Sponsors (1)

Lead Sponsor Collaborator
Prothione, LLC

Country where clinical trial is conducted

Rwanda, 

Outcome

Type Measure Description Time frame Safety issue
Other Quantitative changes in viral load from baseline (Screening Visit) to Day 29. Exploratory Outcome Baseline to day 29
Other Change from baseline to Day 29 in pulse oxygen saturation (SpO2) Exploratory Outcome Baseline to day 29
Other Change from baseline to Day 29 in Quantitative C-Reactive Protein level Exploratory Outcome Baseline to Day 29
Other Change from baseline to Day 29 in Lymphocyte Count Exploratory Outcome Baseline to Day 29
Other Changes in HIV viral load from baseline to Day 29 in HIV positive subjects Exploratory Outcome Baseline to Day 29
Other Duration (days) of hospitalization Exploratory Outcome Baseline to Day 29
Other Time(days) to clinical resolution (TTCR) before Day 14 Exploratory Outcome Before Day 14
Other Time (days) to successful clinical recovery from positive RT-PCR for SARS-COV2 as indicated by three consecutive negative RT-PCR tests measured with two different measurements within a 24-36 hour period before Day 14. Exploratory Outcome within a 24-36 hour period before Day 14
Other Quantitative changes in viral load from baseline (Screening Visit) to Day 14 Exploratory Outcome Baseline to Day 14
Other Change from baseline to Day 14 in Quantitative C-Reactive Protein level Exploratory Outcome Baseline to Day 14
Other Incidence of treatment-related adverse events (TEAEs) Safety Outcome until day 40
Other Incidence and severity of treatment-emergent adverse events (TEAEs) Safety Outcome until day 40
Other Incidence of serious adverse events (SAEs) Safety Outcome until day 40
Other Incidence of TEAEs and SAEs leading to discontinuation of study medication. Safety Outcome until day 40
Other Incidence of abnormal laboratory test results Safety Outcome until day 40
Other Changes in body temperature Safety Outcome until day 40
Other Changes in pulse rate Safety Outcome until day 40
Other Changes in respiratory rate Safety Outcome until day 40
Other Changes in systolic and diastolic blood pressure Safety Outcome until day 40
Other Incidence of abnormal physical examination findings Safety Outcome until day 40
Other Incidence of abnormal electrocardiogram (ECG) results Safety Outcome until day 40
Primary 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 Change from Baseline to Day 29 in Serum 8-OHdG levels Baseline to day 29
Secondary Change in RBC intracellular Glutathione levels to Day 29 Baseline to day 29
Secondary Quantitative change from Baseline (Screening Visit) to Day 29 oropharyngeal cell intracellular GSH levels Baseline to day 29
Secondary 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 ( Each symptom is graded from 0 to 3. [0=none 1=mild 2=moderate and 3=severe] Baseline to day 29
Secondary Evaluate Cycle Threshold (Ct) numbers used in qualitative and quantitative RT-PCR for SARS-COV2 tests. Baseline to day 29
Secondary Clinical Improvement as assessed by change in symptom score from baseline (for fever, myalgia, dyspnea and cough). Note: The score per patient ranges from 0 to 3 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe] Baseline to day 29
Secondary Mortality at Day 29 Day 29
See also
  Status Clinical Trial Phase
Completed NCT04516564 - A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects Phase 1
Withdrawn NCT04519424 - CSL324 in COVID-19 Phase 2
Not yet recruiting NCT04395170 - Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19. Phase 2/Phase 3
Completed NCT05437289 - A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults Phase 1
Completed NCT05594147 - An Observational Study, Called ROCURS, to Learn About COVID-19 Related Outcomes in People With Cancer Who Are Treated With Tyrosine Kinase Inhibitors (TKIs) Including Regorafenib or Sorafenib
Withdrawn NCT04848467 - COVID-19: A Trial Studying the SARS-CoV-2 mRNA Vaccine CVnCoV to Learn About the Immune Response, the Safety, and the Degree of Typical Vaccination Reactions When CVnCoV is Given at the Same Time as a Flu Vaccine Compared to When the Vaccines Are Separately Given in Adults 60 Years of Age and Older Phase 3
Completed NCT04588363 - COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
Terminated NCT04877743 - Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
Completed NCT04378777 - Immunophenotyping Assessment in a COVID-19 Cohort
Completed NCT04375761 - COVID-19: Human Epidemiology and Response to SARS-CoV-2
Completed NCT04545047 - Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
Completed NCT04327206 - BCG Vaccination to Protect Healthcare Workers Against COVID-19 Phase 3
Terminated NCT05375760 - A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19 Phase 2
Completed NCT04344977 - Collection of Anti-SARS-CoV-2 Immune Plasma
Terminated NCT04389840 - Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure Phase 2/Phase 3
Withdrawn NCT04425733 - MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009) Phase 1
Not yet recruiting NCT04438837 - Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers N/A
Completed NCT04409509 - Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19) Phase 2
Completed NCT04275245 - Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia Phase 1/Phase 2
Terminated NCT04638634 - Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects Phase 1