Severe COVID-19, with Acute Respiratory Distress Syndrome (ARDS). MedDRA version: 23.0 Level: LLT Classification code 10084270 Term: SARS-CoV-2 acute respiratory disease System Organ Class: 100000004862
Conditions
Interventions
Product Name: AMY-101 acetate (also known as Cp40 and Cp-14 in the scientific literature/ documentation)
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Not available yet
CA
Sponsors
Amyndas Pharmaceuticals S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adult (age = 18), of any gender. 2.Diagnosed with Acute Respiratory Distress Syndrome due to SARS-CoV-2 infection (severe COVID-19), according to the following criteria: a)Demonstration of SARS-CoV-2 RNAemia in nasopharyngeal swab or bronchio-alveolar lavage (BAL) (note: the test that will be used for SARS-CoV-2 RNAemia is certified with the CE mark and will be used within the scope of its intended purpose) b)A ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2), PaO2/FIO2, =200 mmHg c)Pulmonary infiltrates suggestive of SARS-COV-2-related ARDS: e.g., bilateral infiltrates at chest X-ray or B-lines at lung US scan 3.Dated and signed informed consent from patient or legal represantatives. 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 42
Exclusion criteria
Exclusion criteria: 1.Intubated patients 2.Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or increasing procalcitonin levels =0.5 µg/L) 3.Demonstrated local extrapulmonary abscess 4.ARDS due to cardiac failure or fluid overload 5.Concomitant treatment with immunomodulatory /immunosuppressive drugs, which have potential activity against the disease 6.Concomitant treatment with convalescent plasma 7.Concominant treatment with non-specific intravenous immunoglobulins (IVIG) or SARS-CoV-2 specific immunoglobulins 8.Multi Organ Failure (MOF) 9.Severe renal failure (CKD, by defition glomerular filtration rate <30 ml/min) 10.Neisseria meningitidis infection that is not resolved 11.Current treatment with a complement inhibitor 12.Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening 13.Ongoing participation in another interventional treatment study or participation in another interventional treatment study within 30 days before initiation of the study treatment (Day 1 in this study) or within 5 half-lives of that investigational product, whichever is greater. 14.Chemotherapy for less than 3 months 15.Pregnancy 16.Age <18
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the impact of AMY-101 on the survival without ARDS and without oxygen requirement at day 14 in patients with severe COVID-19. ;Secondary Objective: The secondary objectives are to assess the safety, further measures of clinical efficacy and PK/PD of AMY-101 in patients.;Primary end point(s): The primary endpoint of the study is the proportion of patients who are alive, without evidence of ARDS (as denoted by PaO2/FIO2 >300 mm Hg), who do not require any oxygen support (in room air), at day 14.;Timepoint(s) of evaluation of this end point: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Clinical status will be assessed on a six-category ordinal scale, looking to the proportion of patients assigned to each category at day 7, 14, 21 and 44. Six-category ordinal scale in accordance to Wang Y, et al., Lancet 2020: •1: not hospitalized; •2: hospitalized, not requiring supplemental oxygen; •3: hospitalized, requiring supplemental oxygen; •4: hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; •5: hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and •6: death -Proportion of patients without evidence of ARDS (as denoted by PaO2/FIO2 >300 mm Hg), who do not require any oxygen support (in room air), on Day 7 and on Day 10. -Proportion of patients surviving on day 44. -Respiratory failure-free survival, at day 44, with respiratory failure defined as any of the following (Nava S and Hill N, 2009): 1)Worsening of severe gas transfer deficit, accounting for a shift in ARDS disease category (PaO2/FiO2 =200 for patients with PaO2/FiO2 >200 at baseline; PaO2/FiO2 =100 for patients with PaO2/FiO2 >100 at baseline), 2)Persistent respiratory distress while receiving oxygen (persistent marked dyspnea, use of accessory respiratory muscles, paradoxical respiratory movements), 3)?ransfer to the intensive care unit for intubation, 4)Death. -Cumulative incidence of resolution of ARDS (defined as PaO2/FiO2 =300 in room air) through day 44 -Cumulative incidence of freedom from O2 requirement through day 44 -Proportion of patients requiring invasive mechanical ventilation due to worsening of ARDS within 14 days after inclusion in the study -Proportion of patients requiring non-invasive mechanical ventilation (NIV) due to worsening of ARDS within 14 days after inclusion in the study -Proportion of patients developing thrombotic complications (thrombotic macro- or/and micro-angiopathy or/and thromboembolism) through day 44 -Changes in PaO2 and PaO2/FIO2 -Change | — |
Countries
Greece
Contacts
Public ContactPanagiotis Skendros, MD, PhD
University Hospital of Alexandroupolis
Outcome results
None listed