A Phase II, randomized, open–label study to evaluate the efficacy and tolerability of treatment with vafidemstat in combination with standard of care treatment to prevent Acute Respiratory Distress Syndrome (ARDS) in adult severely ill patients with COVID-19.

Oryzon Genomics S. A.0 sites40 target enrollmentApril 27, 2020

Overview

No summary available.

Registry

who.int

Start Date

April 27, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Oryzon Genomics S. A.

•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:

•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)
•\- 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)]