Treatment for respiratory complications of COVID-19 disease MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: N-003 (Ambrisertan)
Product Code: N-003
Pharmaceutical Form: Oral solution
INN or Proposed INN: Ambrisentan
CAS Number: 177036-94-1
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
Noorik Biopharmaceuticals AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject (or legally authorized representative) provides informed consent (written or oral) prior to initiation of any study procedures. • Male or non-pregnant, non-lactating female. Women of child-bearing potential must have a confirmed negative serum pregnancy test at the time of screening and must use a highly effective contraceptive method throughout the study (such as implants, injectables, hormonal contraceptives and condom, double barrier contraception [i.e., condom + diaphragm/spermicidal gel or foam]) and until one month after completing treatment with the study medication. In the case of hormonal contraception, women should have been on a stable regimen for a minimum of three months before study enrolment. Women not of child-bearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy). Men must use an effective contraception method (i.e., condom + diaphragm/spermicidal gel or foam, or vasectomy), and should not donate semen during the study. Men are considered to be fertile from the time of puberty, except for those men with permanent sterility secondary to bilateral orchiectomy. • At least 18 years of age and not older than 85 years of age at time of enrolment • Confirmed SARS-CoV-2 infection defined as: - Positive RT-PCR result in sample collected in the 10 days prior to randomisation, OR - Positive antigenic test result in sample collected in 10 days prior to randomisation. • Radiological confirmation of pneumonia. • Subject receiving low-flow oxygen supplementation of at least 3 L/min and not more than 15 L/min. • Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. • Subject (or legally authorized representative) agrees to not participate in any other clinical trial, including clinical trials for the treatment or prevention of COVID-19 or SARS-CoV-2 through Day 30. 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
Exclusion criteria: • Subject at a high risk of death, according to investigator’s opinion, in the 3 months following enrolment from other causes than Acute Respiratory Distress Syndrome (e.g., severe neurological damage or cancer patients in terminal stages of the disease). • Subject currently being treated with an endothelin receptor antagonist. • Subject currently being treated with another pulmonary vasodilator. • Anticipated need for high-flow oxygen supplementation, non-invasive mechanical ventilation, endotracheal intubation or tracheostomy at the time of screening.. • History of mechanical ventilation (invasive or non-invasive) in the last 7 days. • Documented history of end-stage liver disease, cirrhosis or idiopathic pulmonary fibrosis (IPF) with or without pulmonary arterial hypertension. • AST o ALT > 3-times the upper limit of normal (ULN) • Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 96 hours. • Participation in another interventional clinical trial in the 15 days prior to enrolment. • Known hypersensitivity to ambrisentan or propylene glycol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether N-003 (ambrisentan) can prevent the progression to respiratory failure or death.;Secondary Objective: To determine: • Whether ambrisentan can delay progression to respiratory failure or death. • Whether ambrisentan can reduce dependency on oxygen supplementation and mechanical ventilation. • Whether ambrisentan can reduce the duration of hospitalisation. • Whether ambrisentan can reduce the need for Intensive Care or High-Dependency Unit. • The temporal characteristics of respiratory function in subjects treated with ambrisentan. • Whether ambrisentan can improve respiratory function. • Whether ambrisentan can reduce the incidence of thrombotic events. • Whether ambrisentan can improve the overall clinical status of subjects. ;Primary end point(s): The primary efficacy endpoint is • Proportion of subjects alive and not having developed respiratory failure from randomisation to Day 30;Timepoint(s) of evaluation of this end point: Progression to respiratory failure, and the proportion of patients not developing respiratory failure in a 30-day observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints evaluated in this study will consist of: • Proportion of subjects alive and free of respiratory failure at Day 14 and Day 30. • Proportion of subjects alive and not requiring oxygen supplementation or higher respiratory support at Day 14 and Day 30. • Time to hospital discharge (up to Day 30). • Proportion of subjects admitted to the Intensive Care Unit or High-Dependency Unit (up to Day 30). • Time until weaning from oxygen therapy (up to Day 30). • Time until weaning from respiratory support other than low-flow oxygen supplementation for subjects having developed respiratory failure (up to Day 30). • Change in SpO2/FiO2 from baseline to the time-weighted average obtained on Day 3. • Change in SpO2/FiO2 from baseline to the time-weighted average obtained on Day 1 and Day 2. • Proportion of subjects experiencing at least one event of venous thrombosis (specifically deep venous thrombosis or pulmonary embolism) (up to Day 30). • Proportion of subjects by clinical status reported on a 11-point ordinal scale at Day 14 and Day 30. • Time to death due to any cause (up to Day 30). • All-cause mortality at Day 30.;Timepoint(s) of evaluation of this end point: Timepoints for each secondary endpoint are indicated in secondary endpoint section E.5.2 | — |
Countries
Croatia, Czechia, Czech Republic, Georgia, Romania, Slovakia, Spain
Contacts
Public ContactCEO
Noorik Biopharmaceuticals AG
Outcome results
None listed