Acute respiratory distress syndrome (ARDS) caused by COVID-19 or other disorders MedDRA version: 21.1 Level: PT Classification code 10001052 Term: Acute respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Octreotide subcutaneous depot
Product Code: CAM2029
Pharmaceutical Form: Prolonged-release solution for injection
INN or Proposed INN: octreotide
Current Sponsor code: CAM2029
Other desc
Sponsors
Camurus AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patient, >18 years old at the time of screening • ARDS according to the Berlin definition at the time of randomization: - PaO2/FiO2 or = 5 cm H2O on Day 1 - Bilateral lung opacities not fully explained by effusions, lobular/lung collapse, or nodules as determined by chest imaging (X-ray or computed tomography [CT] scan) - Respiratory failure not fully explained by cardiac failure or fluid overload • Written informed consent provided by the patient (or legally authorized representative) prior to performing any trial related procedures 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 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: • A candidate for hospice or palliative care • Treatment with somatostatin analogue (e.g. octreotide or lanreotide), pasireotide, bromocriptine/cabergoline or pegvisomant in the past 3 months or plans to receive such treatment during the trial period • Treatment with chloroquine or hydroxychloroquine in the past 30 days • Treatment with concomitant medication(s) with a known risk of Torsades de Pointes within 7 days prior to screening • Currently taking part in another interventional clinical trial • History of hypersensitivity or allergy to octreotide • Evidence of poorly controlled diabetes (hemoglobin A1c > or = 10%) at screening • Known history of, or evidence at screening of, QT prolongation, or having other risk factors for Torsades de Pointes according to the Investigator’s judgement • Hepatic- or pancreatic-related disorder, including hepatic cirrhosis, viral hepatitis, gallbladder or bile duct disease, acute or chronic pancreatitis or symptomatic cholelithiasis • Cardiac disease: - Myocardial infarction or coronary artery bypass graft within 6 months, or - Ongoing arrhythmias, complete left bundle branch block or high-grade atrioventricular heart block • Untreated or uncontrolled hypothyroidism • Abnormal liver laboratory parameters at screening: aspartate aminotransferase or alanine aminotransferase > or = 3.0 × upper limit of normal (ULN) combined with total bilirubin >2 × ULN and amylase or lipase > or = 3.0 × ULN • Severe renal failure requiring dialysis • Malignancy or other irreversible disease or condition for which 6-month mortality is estimated at 50% or more • Pre-existing neuromuscular disease impairing spontaneous ventilation • Any other serious medical condition that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial • Pregnant or lactating women • On the staff, affiliated with, or a family member of the personnel directly involved with this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the treatment effect of CAM2029 versus placebo on respiratory function in patients diagnosed with acute respiratory distress syndrome (ARDS);Secondary Objective: To evaluate the treatment effect of CAM2029 on respiratory function To evaluate the treatment effect of CAM2029 on mortality To evaluate the treatment effect of CAM2029 on the stay in the hospital To evaluate the treatment effect of CAM2029 on the stay in the Intensive Care Unit (ICU) To evaluate the impact of CAM2029 on the patient’s clinical status To evaluate the treatment effect of CAM2029 on the patient’s disease-specific, health-related quality of life To evaluate the treatment effects of CAM2029 on measures of general, physical, mental and psychosocial functioning To evaluate the treatment effect of CAM2029 on serum insulin-like growth factor-1 (IGF-1) To assess the plasma concentrations of octreotide after administration of CAM2029 To evaluate the treatment effect of CAM2029 on inflammatory markers To evaluate the safety of CAM2029;Primary end point(s): Time to improvement of > or = 2.0 in oxygenation saturation index sustained for at least 48 hours;Timepoint(s) of evaluation of this end point: Day 1 (baseline) to Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to improvement in oxygenation sustained for at least 48 hours • Proportion of patients alive on Day 28 with an improvement of > or = 2.0 in oxygenation saturation index sustained for at least 48 hours • Time to improvement of > or = 2.0 in oxygenation index sustained for at least 48 hours • Alive, mechanical ventilation-free days • Alive, respiratory-failure-free days • Proportion of patients who are alive and respiratory-failure-free on Day 28 • All-cause mortality on Day 28 • Number of days in the hospital • Proportion of patients who are alive and discharged from the hospital on Day 28 • Number of days in the ICU • Proportion of patients who are alive and discharged from the ICU on Day 28 • Clinical status pattern over time using a modified ordinal scale • Saint George’s Respiratory Questionnaire (SGRQ) • King’s Brief Interstitial Lung Disease (KBILD) • Short Form-36 (SF-36) • Hospital Anxiety and Depression Scale (HADS) • Change from baseline in the levels of serum IGF-1 and insulin-like growth factor-binding protein 3 (IGFBP-3) • Octreotide plasma concentrations over time • Change from baseline in the levels of interleukin-6 (IL-6) and C-reactive protein (CRP) • Proportion of patients with treatment-emergent severe fatal or life-threatening serious adverse events (SAEs) • Proportion of patients with treatment-emergent adverse events (AEs) of special interest;Timepoint(s) of evaluation of this end point: Day 1 (baseline) to Day 84 Day 28 Baseline to last available assessment | — |
Countries
Italy, Spain, United States
Contacts
Public ContactClinical Development and Ph.Vig.
Camurus AB
Outcome results
None listed