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Coronavirus Disease 2019 (COVID-19)Phase 2NCT04742725

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

A Phase 2 study testing Prothione™ (6g) in people with Coronavirus Disease 2019 (COVID-19), run by Prothione, LLC at 1 site in Rwanda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Disease 2019 (COVID-19)
What is being tested?
Prothione™ (6g)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
231 participants
Where
1 siteRwanda
Study dates
25 May 2021to 21 Sep 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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™ ).
  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

Rwanda1 site

  • Rinda Ubuzima

    Kigali

Other trials in Rwanda

About this study

Official title: 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)

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

Read more

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:
  1. Canadian Patent No. 2963131
  2. Australian Patent No. 2018279015
Read the 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.

Being tested
Placebo, Prothione™ (6g)
Keywords
COVID-19, Prothione
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo

  • Prothione™ (6g)Drug

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

Study groups in NCT04742725
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Prothione ™ExperimentalNot described
Receives: Drug: Prothione™ (6g)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24-36 hour period

Secondary outcomes (7)

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

    Measured: Baseline to day 29

  2. Change in RBC intracellular Glutathione levels to Day 29

    Measured: Baseline to day 29

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

    Measured: Baseline to day 29

  4. 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]

    Measured: Baseline to day 29

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

    Measured: Baseline to day 29

  6. 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]

    Measured: Baseline to day 29

  7. Mortality at Day 29

    Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2021
  2. Study start25 May 2021
  3. Primary completion21 Sep 2021
  4. Study completion21 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742725
Sponsor's protocol ID
TAL-PRO-001
Status last verified
Apr 2022
First submitted
3 Feb 2021
Last updated
21 Apr 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prothione™ (6g) in people with Coronavirus Disease 2019 (COVID-19), run by Prothione, LLC at 1 site in Rwanda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.

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