Acute Respiratory Distress Syndrome (ARDS) MedDRA version: 21.1 Level: LLT Classification code 10003083 Term: ARDS System Organ Class: 100000004855
Conditions
Interventions
Product Name: Vafidemstat
Product Code: ORY-2001
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: VAFIDEMSTAT
CAS Number: 1357247-95-0
Concentration unit: mg milligram(s)
Concentration type: ra
Sponsors
Oryzon Genomics S. A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult, age >=18 years 2) Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples, no more than 72h before randomization to study treatment 3) Patients admitted to hospital ward and at risk of ADRS or respiratory failure which will require mechanical ventilation 4) Severity of symptoms 3-4 according to WHO 7-point Global Overall Symptom scale (measures severity symptoms in clinical trials) - Severity 3 – Hospitalized NO requiring supplemental oxygen - Severity 4 - Hospitalized requiring supplemental oxygen 5) Confirmed CoVID-19 pneumonia diagnosis/bilateral pulmonary infiltrate of any severity, with = 72h duration and meeting at least one of the following criteria for severe condition: - X-Ray progression (Pulmonary X-Ray with increased extension or increased number of infiltrates at control) - IL-6 elevation - Increase in at least one of the following systemic and pulmonary inflammatory biomarkers: - D-dimer >1000 µg/L - PCR > 5 mg/dL - LDH >300 UI/L - Ferritin >200 ng/mL - Total Lymphocytes =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1) Platelets <150000/mm3 2) Neutrophils <1500/mm3 3) Mechanical ventilation that prevents administration of vafidemstat oral treatment 4) Investigator considers patient unsuitable 5) Women who are pregnant or breast-feeding (*) *Fertile male and female must use highly efficient contraception until 30 days after last dose of the study treatment, defined as: - A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner) OR - The use of two methods of contraception [(one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive (e.g., combined oral contraceptives, patch, vaginal ring, injectable and implants)]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of vafidemstat, in combination with standard of care treatment (e.g., hidroxihidroxichloroquine, lopinavir/ritonavir, azithromycin, or any other being applied by the Hospitals according to the current guides) to prevent Acute Respiratory Distress Syndrome (ARDS) in adult severely ill patients with CoVID-19.;Secondary Objective: To evaluate the tolerability of vafidemstat, in combination with standard of care treatment (e.g., chloroquine, lopinavir/ritonavir, azithromycin, or any other being applied by the Hospitals according to the current guides), to prevent Acute Respiratory Distress Syndrome (ARDS) in adult severely ill patients with CoVID-19.;Primary end point(s): • Reduction in the incidence of patients (%) requiring mechanical ventilation and referral to ICU within the period from Day 1 (i.e.: first study drug administration) to Day 14 • Decrease in global mortality and mortality associated to CoVID-19 pneumonias within the period from Day 1 (i.e.: first study drug administration) to Day 14;Timepoint(s) of evaluation of this end point: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Reduction in the incidence of patients (%) requiring mechanical ventilation and referral to ICU within the period from Day 15 to Day 28 • Decrease in global mortality and mortality associated to CoVID-19 pneumonias within the period from Day 15 to Day 28 • Improvement in O2Sat (%) and decrease in supplemental O2 needed at Day 5, Day 14 and Day 28 • Time to development of ADRS or respiratory failure for CoVID-19 requiring intubation and mechanical ventilation from Day 1 to Day 28 • Reduce in the incidence of patients (%) requiring rescue medication with anti IL-6 • Reduction in Laboratory parameters at Day 5, Day 14 and Day 28: o Systemic and pulmonary inflammatory biomarkers associated to CoVID-19 pneumonia: IL-6, IL1-beta, D-dimer-D, PCR, LDH, Ferritin, Total Lymphocytes • Impact on hematological safety values (i.e.: platelets and neutrophils) at Day 5, Day 14 and Day 28;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
Spain
Contacts
Public ContactSonia Gutiérrez
Oryzon Genomics S. A.
Outcome results
None listed