A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, MULTI CENTER STUDY OF OT 101 IN HOSPITALIZED COVID 19 SUBJECTS

INTERVENTION: Group name:OT‐101 Type of group;1 N° of participants:48 Intervention(s) description:Name of the IMP: OT 101 (Trabedersen, TGF‐β2 specific synthetic 18 mer phosphorothioate antisense oligodeoxynucleotide). Dose and dosage regimen: Days 1 to 7: 140 mg/m2 daily intravenous (i.v.) infusion for 7 continuous days. Formulation: Lyophilized powder. Group name:Placebo Type of group;2 N° of participants:24 Intervention(s) description:Dose and dosage regimen: Days 1 to 7 daily i.v. infusion for 7 continuous days. Formulation: Saline solution CONDITION: ‐B342 Coronavirus infection, unspecified site ; Coronavirus infection, unspecified site B342 Coronavirus infection, unspecified site PRIMARY OUTCOME: 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 OUTCOME: 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: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:Days of hospitalization ; Measure:For subjects with mild or severe COVID‐19 when applicable: ; • Duration of hospitalization by Days 7, 14, 21, and 28. ; Timepoints:From Day 1 to Day 7, 14, 21 and 28 Outcome name:Days of ICU stay ; Measure:For subjects with mild or severe COVID‐19 when applicable: ; Duration of intensive care unit stay 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. ; Timepoints:From Day 1 to Day 7, 14, 21 and 28 Outcome name:days of ventilation from initiation of treatment ; Measure:For subjects with mild or severe COVID 19 when applicable: ; • Days of ventilation ; Timepoints:From day 1 to 28 days 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:days without mechanical ventilation from initiation of treatment ; Measure:For subjects with mild or severe COVID 19 when applicable: ; • Ventilator free days by Day 14 and Day 28. ; Timepoints:From day 1 to day 14 , 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 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 <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