COVID-19 infection MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Trans Sodium Crocetinate Crocetinate
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: N/A
CAS Number: 64603-92-5
Current Sponsor code: TRANS SODIUM CROC
Sponsors
Diffusion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospitalized subjects with confirmed SARS-CoV-2 infection and hypoxemia, defined as SpO2 =65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Intubated and mechanically ventilated at baseline 2. Receiving extracorporeal membrane oxygenation (ECMO) at baseline 3. Severe organ dysfunction (SOFA score > 10) 4. Patient or LAR unable to provide written informed consent 5. ALT/AST > 5 times the upper limit of normal. 6. Stage 3 (EGFR by MDRD) severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) 7. Pregnancy or breast feeding. 8. Anticipated transfer to another hospital which is not a study site within 72 hours. 9. Allergy to any study medication 10. Moribund patient not expected to survive 24 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Lead in Pk/PD: 1. Determine the safety and tolerability of TSC when administered four times per day (every 6 hours) for up to 5 days for each of the four doses to be studied. Randomized Pilot: 1. Determine the safety and efficacy of TSC administered at the optimum, safe and tolerable biologic dose four times per day (every 6 hours) for up to 15 days as compared to placebo;Secondary Objective: Lead in Pk/PD: 1.Determine the relative degree of improvement by TSC dose in blood oxygenation following treatment with TSC as measured by the SpO2:FiO2 (S:F) ratio via continuous pulse oximetry. 2.PK/PD determine blood oxygenation by PaO2:FiO2 (P:F) ratio or S:F ratio following the TSC admin. 3.Determine the optimum, safe and tolerable biologic dose of TSC among the four doses to be studied given four times per day (every 6 hours) for up to 5 days using the S:F ratio Randomized Pilot: 1.Demonstrate that TSC is not associated with an increased occurrence of serious adverse events in COVID-19 patients. The study endpoint analysis will compare the frequency of SAEs in the TSC and placebo groups. 2.Demonstrate that treatment with TSC is not associated with increases in any organ-specific classes of serious adverse events or increased mortality. ;Primary end point(s): Lead-In PK/PD • Serious adverse events / Adverse events (Dose Limiting Toxicity) Randomized pilot • Time to recovery through Day 28, defined as time to achieve (and maintain through Day 28) a WHO ordinal severity scale score of 1, 2 or 3 with a minimum 1-point improvement from baseline ;Timepoint(s) of evaluation of this end point: Lead-In PK/PD Dose Selection: Serious adverse events/adverse events (following 5 days treatment) Randomized Pilot: day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: WHO scale days 3, 5, 8, 11, 15 and 29 NEWS days 3, 5, 8, 11, 15,29 in NEWS Oxygenation Oxygen free days in the first 28 days (to day 29) Blood oxygenation prior to 1st dose of TSC and at 1 min, 30 min, 1.5 , 3 and 6 hrs post TSC adm. by calculated PaO2:FiO2 ratios. -Ventilator free days in the first 28 days -Incidence and duration of new mechanical ventilation use during the trial Hospitalization -Hospital and ICU length of stay by Day 29 Mortality -15-day/28-day/ mortality All cause mortality at Day 29 In hospital mortality Mortality at Day 60 Other - SOFA Score at baseline, 24 and 48 hours, Day 7and 15 -28-day new RRT free days Safety Changes in wbc, hgb, plt, cr glucose, T bilirubin, ALT / AST from day 1 through day 15 and day 29 AE, SAE to day 60;Secondary end point(s): WHO Ordinal scale o Time to improvement of one category from admission on the ordinal scale o Subject clinical status on an ordinal scale at days 3, 5, 8, 11, 15 a nd 29 o Mean change in the ranking on an ordinal scale from baseline to days 3, 5, 8, 11, 15 and 29 National Early Warning Score (NEWS) o The time to discharge or to a NEWS of 20 L/min with fraction of delivered oxygen > 0.5) o Noninvasive positive pressure ventilation o Extracorporeal membrane oxygenation o Clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision making is driven solely by resource limitation Safety o Cumulative incidence of serious adverse events (SAEs)to Day 60 o Cumulative incidence of Grade 3 or 4 adverse events (AEs)to Day 60 o Discontinuation or temporary suspension of study drug injections (for any reason) o Changes in white cell count, haemoglobin, platelets, creatinine glucose, total bilirubin, ALT and AST on days 1, 3, 5, 8, 11 (while hospitalized); and Day 15 and 29 ( if able to return to clinic or still hospitalized) | — |
Countries
Romania
Contacts
Public ContactChairman and CEO
Diffusion Pharmaceuticals Inc
Outcome results
None listed