Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05212662 |
| Other study ID # |
TTI-CV-001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
May 2023 |
| Source |
Thiogenesis Therapeutics, Inc. |
| Contact |
COVID-19 Clinical Trial Recruitment |
| Phone |
+1 (858) 500-6621 |
| Email |
mbagger[@]thiogenesis.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
All patients with confirmed COVID-19 will be managed within an outpatient continuum of care
management program that includes self-assessment tools; initial telephone triage; coordinated
outreach and management approach based upon individual patient risk, severity of symptoms,
and time course of disease; clinician telehealth (telephone call or video platform-based)
visits (initial evaluation and follow-up visits); COVID-19 testing; a separate outpatient
respiratory clinic or dedicated space within an ambulatory clinic appropriated for the care
of patients with COVID-19 and other respiratory problems; strategies to reduce the risk of
exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by staff and other
patients will be employed.
Screening Period - Remote Patients will undergo screening to determine study eligibility, for
a period of not more than 7 days. It is not required that patients come to study investigator
clinic for screening assessments, but SARS-CoV-2 PCR test results, medical history and vital
signs used to verify study eligibility must be collected from the non-investigator facility
that performed them, reviewed prior to Day 1, placed in the subjects' source documentation
and transcribed to the CRF. The Ethics Committee or Institutional Review Board must approve
the informed consent template and the remote consent process and documentation to be utilized
for the trial.
Treatment Period (Days 1-14)
- Day 1 Clinic Visit: Eligible subjects will be enrolled into the study, i.e.
randomization will take place, they will receive their first dose of study drug
(TTI-0102 or placebo) in clinic, and they will be dispensed enough to continue treatment
at home for up to 14 days. Baseline assessments will be performed according to Appendix
22.1 Schedule of Assessments.
- Day 8 - Remote Visit: Subjects will be contacted to assess their tolerance to study
drug. Subjects unable to tolerate the 5.5 gram daily dose (QD) will be instructed to
split the dose into two 2.75 gram half-doses taken in the morning and the evening (BID).
- Day 14 - Clinic Visit: Subjects will return to clinic for end-of-treatment assessments
specified in Appendix 22.1 Schedule of Assessments.
Subjects will continue daily study drug treatment as outpatients, under home quarantine as
per local Public Health guidelines. Subjects will also receive continued standard of care
therapy per study site written policies or guidelines. Study drug treatmetn should continue
for 14 days, or earlier as medically appropriate (e.g., deterioration of clinical status and
alternative therapy required). If the patient requires hospitalization during the study
period, study drug treatment will be discontinued.
The following safety assessments will be performed at timepoints specified in the Appendix
22.1 Schedule of Assessments. In addition to unsolicited, spontaneous adverse events which
are reported or observed, patients will be interviewed for additional cysteamine-associated
adverse events using a protocol-specific checklist [Appendix 22.8]. Subjects will also be
asked to complete the Gastrointestinal Symptom Rating Scale (GSRS) [Appendix 22.7] and a
COVID-19 symptoms questionnaire [Appendix 22.6].
If a patient is required to show up in an outpatient clinic, physical examinations,
electrocardiograms (ECGs), vital signs, and clinical laboratory evaluations (chemistry,
hematology, urinalysis) will be performed. A standardized toxicity grading scale will be used
to grade the severity of adverse events, National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI CTCAE) [Appendix 22.9].
Study Termination: Day 28 or upon Early Withdrawal - Remote Visit A remote (telephone or
video) Study Termination Visit will take place on Day 28 for patients who completed treatment
or, for patients who withdraw early, 2 weeks (14 days) after the last study drug dose.
Follow-up Period - Remote Visits Follow-up telephone contact #1 will be performed on Day 42
or 28 days/4 weeks after last study drug dose. Follow-up telephone contact #2 will take place
on Day 70, or 56 days/7 weeks after last study drug dose.
