Study to evaluate the efficacy and tolerability of treatment with vafidemstat in combination with standard of care treatment to prevent Acute Respiratory Distress Syndrome in adult severely ill patients with COVID-19.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS)MedDRA version: 21.1Level: LLTClassification code 10003083Term: ARDSSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001618-39-ES
- Lead Sponsor
- Oryzon Genomics S. A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
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 <1000 /mL
6) Ideally, treatment can be started no more than 5-7 days since the onset of symptoms
7) Sign the Informed Consent Form on a voluntary basis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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)]
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method