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

Studies

Study First Submitted Date 2022-01-26
Study First Posted Date 2022-01-28
Last Update Posted Date 2023-05-03
Start Month Year June 2024
Primary Completion Month Year June 2025
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-03

Detailed Descriptions

Sequence: 20713229
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.

Browse Interventions

Sequence: 96013132 Sequence: 96013133 Sequence: 96013134
Mesh Term Cysteamine Mesh Term Cystine Depleting Agents Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term cysteamine Downcase Mesh Term cystine depleting agents Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52148140 Sequence: 52148141
Name COVID-19 Name COVID-19 Acute Respiratory Distress Syndrome
Downcase Name covid-19 Downcase Name covid-19 acute respiratory distress syndrome

Id Information

Sequence: 40141866
Id Source org_study_id
Id Value TTI-CV-001

Design Groups

Sequence: 55568896 Sequence: 55568897
Group Type Experimental Group Type Placebo Comparator
Title TTI-0102 Title Placebo
Description Cysteamine-pantetheine disulfide (TTI-0102) is supplied in a vial as a powder to be dissolved in water and administered orally. Description Placebo is supplied in a vial as a powder to be dissolved in water and administered orally.

Interventions

Sequence: 52463971 Sequence: 52463972
Intervention Type Drug Intervention Type Drug
Name TTI-0102 Name Placebo
Description 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. Description Placebo comparator supplied in vials identical to the active intervention, TTI-0102

Design Outcomes

Sequence: 177299274 Sequence: 177299275 Sequence: 177299276
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Primary Endpoint Measure Secondary: Safety Measure Secondary: Efficacy
Time Frame 28 days Time Frame 28 days Time Frame 28 days
Description Frequency of hospitalization or death Description Frequency of adverse events Description Change of COVID-19 symptoms (self-assessment) score from Baseline, as measured at Day 14 and Day 28.

Browse Conditions

Sequence: 193400654 Sequence: 193400655 Sequence: 193400656 Sequence: 193400657 Sequence: 193400658 Sequence: 193400659 Sequence: 193400660 Sequence: 193400661 Sequence: 193400662 Sequence: 193400663 Sequence: 193400664 Sequence: 193400665 Sequence: 193400666 Sequence: 193400667 Sequence: 193400668 Sequence: 193400650 Sequence: 193400651 Sequence: 193400652 Sequence: 193400653
Mesh Term Pneumonia, Viral Mesh Term Pneumonia Mesh Term Respiratory Tract Infections Mesh Term Infections Mesh Term Virus Diseases Mesh Term Coronavirus Infections Mesh Term Coronaviridae Infections Mesh Term Nidovirales Infections Mesh Term RNA Virus Infections Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases Mesh Term Respiration Disorders Mesh Term Infant, Premature, Diseases Mesh Term Infant, Newborn, Diseases Mesh Term Lung Injury Mesh Term COVID-19 Mesh Term Respiratory Distress Syndrome Mesh Term Respiratory Distress Syndrome, Newborn Mesh Term Acute Lung Injury
Downcase Mesh Term pneumonia, viral Downcase Mesh Term pneumonia Downcase Mesh Term respiratory tract infections Downcase Mesh Term infections Downcase Mesh Term virus diseases Downcase Mesh Term coronavirus infections Downcase Mesh Term coronaviridae infections Downcase Mesh Term nidovirales infections Downcase Mesh Term rna virus infections Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases Downcase Mesh Term respiration disorders Downcase Mesh Term infant, premature, diseases Downcase Mesh Term infant, newborn, diseases Downcase Mesh Term lung injury Downcase Mesh Term covid-19 Downcase Mesh Term respiratory distress syndrome Downcase Mesh Term respiratory distress syndrome, newborn Downcase Mesh Term acute lung injury
Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list

Sponsors

Sequence: 48298572
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Thiogenesis Therapeutics, Inc.

Overall Officials

Sequence: 29273034
Role Study Director
Name Patrice P Rioux, MD, PhD
Affiliation Sponsor: Thiogenesis Therapeutics, Inc.

Central Contacts

Sequence: 12003230 Sequence: 12003231
Contact Type primary Contact Type backup
Name COVID-19 Clinical Trial Recruitment Name Patrice P Rioux, MD, PhD
Phone +1 (858) 500-6621 Phone +1 (408) 677-0682
Email mbagger@thiogenesis.com Email prioux@thiogenesis.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68120181 Sequence: 68120182
Design Group Id 55568896 Design Group Id 55568897
Intervention Id 52463971 Intervention Id 52463972

Eligibilities

Sequence: 30752589
Gender All
Minimum Age 18 Years
Maximum Age 80 Years
Healthy Volunteers No
Criteria 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. 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 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. 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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254178969
Registered In Calendar Year 2022
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30498857
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Quadruple
Subject Masked True
Caregiver Masked True
Investigator Masked True
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26661803
Intervention Id 52463971
Name cysteamine-pantetheine disulfide

Responsible Parties

Sequence: 28865131
Responsible Party Type Sponsor