Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19

NCT05212662 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: TTI-CV-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacodynamics (PD) and efficacy of TTI-0102 for the treatment of patients with mild to moderate COVID-19. This is a phase 2 study of cysteamine-pantetheine disulfide (TTI-0102), an antiviral, anti-infectious, antioxidant and anti-CRS (cytokine release syndrome) investigational drug. Subjects will be randomized 2:1 to receive TTI-0102 or placebo daily for up to 14 days. Up to 5 centers in the US and Canada will conduct this study. 60 patients will be enrolled.

Conditions

COVID-19; COVID-19 Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Frequency of hospitalization or death

  28 days

Secondary Outcomes (2)

• Secondary: Safety

  28 days

• Secondary: Efficacy

  28 days

Study Arms (2)

TTI-0102

EXPERIMENTAL

Cysteamine-pantetheine disulfide (TTI-0102) is supplied in a vial as a powder to be dissolved in water and administered orally.

Drug: TTI-0102

Placebo

PLACEBO COMPARATOR

Placebo is supplied in a vial as a powder to be dissolved in water and administered orally.

Drug: Placebo

Interventions

TTI-0102 DRUG

The study treatment is a precursor to cysteamine, TTI-0102 (cysteamine-pantetheine disulfide). Each molecule of TTI-0102, after reduction and metabolism in the digestive tract, allows the absorption of 2 molecules of cysteamine and one molecule of pantothenic acid (Vit B5). Each dose of TTI-0102 comes in a vial as a powder to dissolve in water and absorb orally. Each vial contains 5.5g of TTI-0102, corresponding to the equivalent of 2.4g of cysteamine base. This single dose is less than the maximum daily dose authorized with other formulations of cysteamine (Cystagon or Procysbi, 1.95 g/m2/day) for patients over 1.25 m2 or 40 kg (88 lbs). This dose of 5.5 g is justified by the need to maintain a thiol/disulfide ratio in favor of cysteamine over 24 h. It has been tested in healthy volunteers and has no side effects due to the specific pharmacokinetics of cysteamine after administration of TTI-0102.

Also known as: cysteamine-pantetheine disulfide

TTI-0102

Placebo DRUG

Placebo comparator supplied in vials identical to the active intervention, TTI-0102

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is between 18 and 80 years of age.
• Is within 72 hours from onset of symptoms consistent with COVID-19 at time of study screening.
• Has at least 2 of the following: fever (oral temperature ≥38°C), cough, shortness of breath, chest x-ray changes consistent with COVID-19 at time of screening.
• Has a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-approved rapid diagnostic (e.g., PCR) assay.
• Has a score of ≤ 2 on the 8-category National Institute of Allergy and Infectious Diseases (NIAID) ordinal rating scale at time of screening. \[Protocol Appendix 22.2\]
• Agrees to the collection of blood and urine samples, nasopharyngeal (NP) swabs, and non-invasive oxygen monitoring (via pulse oximeter) as required by study protocol.
• Patient or their legally authorized representative is willing and able to provide written informed consent prior to performing study procedures.
• Understands and agrees to comply with planned study procedures.
• Women of childbearing potential must agree to either abstinence or use of at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29 following randomization. All subjects of childbearing potential, including males with partners of childbearing potential, must use highly effective methods of birth control defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly \[Protocol Appendix 22.3\]. Abstinence is NOT an acceptable method of contraception UNLESS it is the subject's normal practice

You may not qualify if:

• Is currently hospitalized.
• Prior history of, or considered to be at risk for, agranulocytosis, nephropathy, liver disease or interstitial pneumonia.
• Current or historic positive human immunodeficiency virus (HIV) test.
• Presence of organ transplant.
• Receipt of cancer chemotherapy or immunomodulatory drugs including but not limited to biologics such as anti-CD20, anti-TNF, anti-IL6; alkylating agents (e.g., cyclophosphamide), antimetabolites (e.g., azathioprine), or chronic corticosteroid use equivalent to prednisone \>10 gm/day, during the 2 months prior to screening.
• Confirmed positive for influenza at screening.
• Confirmed positive for respiratory syncytial virus (RSV) at screening.
• Pregnant or breastfeeding.
• Current use of, or known allergy to cysteamine, bucillamine or penicillamine (e.g., for Wilson's disease, rheumatoid arthritis).
• Current participation in any other clinical trial of an experimental treatment for any indication including COVID-19.
• Receipt of any experimental treatment for COVID-19 (herbal, homeopathic, over the counter, off-label, compassionate use, or clinical trial related) within the 30 days prior to screening.
• Receipt of any medication for treatment or prevention of COVID-19 being used pursuant to an Emergency Use Authorization (e.g., vaccine) prior to or during study participation

Sponsors & Collaborators

• Thiogenesis Therapeutics, Inc.: lead

MeSH Terms

Conditions

COVID-19

Interventions

cysteamine-pantetheine disulfide

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

• Patrice P Rioux, MD, PhD

  Sponsor: Thiogenesis Therapeutics, Inc.

  STUDY DIRECTOR

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: January 28, 2022
• Study Start: September 27, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share