None listed
Conditions
Interventions
OT-101 Type of group
Name of the IMP: OT 101 (Trabedersen, TGF-β
Dose and dosage regimen: Days 1 to 7 daily i.v. infusion for 7 continuous days.
Formulation: Saline solution
Sponsors
Oncotelic Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: Each subject must meet all of the following criteria to be eligible for study participation: Part 1: 1. Hospitalized adult male or non-pregnant, non-lactating female subjects (between 18 and 80 years), with SARS-CoV-2, previously known as novel coronavirus (2019-nCoV) infection that is documented by an authorized diagnostic PCR test. A rapid PCR test could also be used. Confirmation that subject has COVID 19 within the last 1 week prior to randomization. 2. Meeting WHO COVID 19 Clinical Improvement Ordinal Scale Criteria 3 (hospitalized, no oxygen therapy) or Criteria 4 (hospitalized, oxygen by mask or nasal prongs). 3. Having at least 1 medical risk factor, i.e. having absolute lymphocyte count 60 years, hypertension, diabetes, cardiac failure or COPD. 4. Male subjects and female subjects of childbearing potential must agree to use protocol specified methods of contraception. 5. Females subjects of childbearing potential and women of non childbearing potential (defined as at least 2 years postmenopausal or permanently sterilized women [bilateral tubal ligation, bilateral ovariectomy, or hysterectomy]) must have a negative serum pregnancy test at screening or pretreatment on Day 1. 6. The subject or a LAR has provided written informed consent. 7. The subject or the LAR is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the ICF. Part 2: Same as part 1 except 1.Meeting WHO COVID 19 Clinical Improvement Ordinal Scale Criteria 5 (non-invasive mechanical ventilation or high-flow oxygen) or Criteria 6 (intubation and mechanical ventilation).
Exclusion criteria
Exclusion criteria: Subjects (in Part 1 and Part 2) who meet any of the following criteria must be excluded from the study: 1. Participation in any other clinical trial of an experimental treatment for COVID-19 or participation in another interventional clinical trial, including an expanded access trial. 2. Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS CoV 2 infection 150 mmHg and/or diastolic blood pressure >100 mmHg), unstable angina, congestive heart failure of any New York Respiratory Association classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), or history of myocardial infarction within 12 months of enrollment. 4. Hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine. 5. Renal function impairment (creatinine clearance [Cr. Cl.] 5 × upper limit of normal (ULN), or ALT/AST >3 × ULN plus total bilirubin >2 × ULN. b. Total bilirubin >1.5 × ULN, unless the subject has known Gilbert’s syndrome. 7. Platelet count <50 000/µL 8. Multi-organ failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:An 8 point WHO COVID 19 Clinical Improvement Ordinal Scale) as assessed by the odds ratio (OR) Measure:The proportion of subjects with clinical improvement score measured by an 8 point WHO COVID 19 Clinical Improvement Ordinal Scale) as assessed by the odds ratio (OR) at Day 14. Clinical improvement is defined as • A score decrease of at least 1 in subjects with mild COVID 19. • A score decrease to categories 1, 2, 3, or 4 in subjects with severe COVID 19. Timepoints:Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:An 8 point WHO COVID 19 Clinical Improvement Ordinal Scale) as assessed by the odds ratio (OR) Measure:•The OR at Days 7, 21, and 28 based on the clinical improvement score (as measured by an 8 point WHO COVID 19 Clinical Improvement Ordinal Scale). Clinical improvement defined as per primary endpoint. Timepoints:Day 7, 21 and 28 ; Outcome name:An 8 point WHO COVID 19 Clinical Improvement Ordinal Scale) as assessed by the odds ratio (OR) Measure:• The OR at Days 7, 14, 21, and 28 of a decrease of at least 1, 2, 3, and 4 points in subjects with severe COVID 19. Timepoints:Day 7, 14, 21 and 28 ; Outcome name:Days to at least 1 point improvement from baseline in subjects with mild COVID 19 Measure:• Time to at least 1 point improvement from baseline on Days 7, 14, 21, and 28 in subjects with mild COVID 19. Timepoints:From Day 1 to Day 7, 14, 21 and 28 ; Outcome name:Days to at least 2-point improvement from baseline in subjects with severe COVID-19 Measure:• Time to at least 2 point improvement from baseline on Days 7, 14, 21, and 28 in subjects with severe COVID 19. Timepoints:From Day 1 to Day 7, 14, 21 and 28 ; Outcome name:Days to at least increase 1 point clinical ordinal score from baseline. Measure:For subjects with mild or severe COVID-19 when applicable: • Worsening (increase in clinical improvement score) of at least ‘1’ score on Days 7, 14, 21, and 28. Timepoints:From Day 1 to Day 7, 14, 21 and 28 ; Outcome name:Percent of patients died within7,14,21 and 28-days period from first dose Measure:For subjects with mild or severe COVID-19 when applicable: • Mortality by Days 7, 14, 21, and 28. Timepoints:From Day 1 to Day 7, 14, 21 and 28 ; Outcome name:Days of supplemental oxygen/ventilator support Measure:For subjects with mild or severe COVID-19 when applicable: • Duration of supplemental oxygen/ventilator support by Days 7, 14, 21, and 28 | — |
Countries
Argentina
Contacts
Public ContactFlor de Liz Jacome
COVANCE PERU SERVICES S.A.
Outcome results
None listed