Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19 (NCT05212662) | Clinical Trial Compass
WithdrawnPhase 2
Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19
Stopped: Sponsor is not pursuing the COVID-19 indication at this time.
0Started 2024-09-27
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. 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.