COVID-19 trials registries data warehouse

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=067-20

Flor de Liz Jacome

liz.jacome@covance.com

2020-10-29

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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 <1000 cells/mm3, age >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).

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 <24 hours prior to study drug dosing except for remdesivir. 3. Uncontrolled hypertension (systolic blood pressure >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.] <50 mL/min, based on Modification of Diet in Renal Disease calculation). 6. Liver function impairment a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >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.

2

Oncotelic Inc.;

18

80

Argentina

Moderate disease at enrollment

3: Moderate disease at enrollment

48

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

Phase 2

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