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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. 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.