Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amyndas Pharmaceuticals S.A.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosed with Acute Respiratory Distress Syndrome due to SARS-CoV-2 infection (severe Covid-19), according to the following criteria:
1. Demonstration of SARS-CoV-2 RNAemia in nasopharyngeal swap or bronchio-alveolar lavage (BAL)
2. A ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2), PaO2/FIO2, ≤300 mmHg
* Mild ARDS (PaO2/FIO2, ≤300 and \>200 mm Hg);
* Moderate ARDS (PaO2/FIO2, ≤200 and \>100 mm Hg);
* Severe ARDS (PaO2/FIO2, ≤100 mm Hg);
3. Pulmonary infiltrates suggestive of SARS-COV-2-related ARDS: e.g., bilateral infiltrates at chest X-ray or B-lines at lung US scan.
Dated and signed informed consent from patient or legal represantative.
You may not be if
Intubated patients
Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or procalcitonin ≥0.25 µg/L)
Demonstrated local extrapulmonary abscess
ARDS due to cardiac failure or fluid overload
Concomitant treatment with immunomodulatory /immunosuppressive drugs , which have potential activity against the disease
Multi Organ Failure (MOF)
Severe renal failure (CKD, by defition glomerular filtration rate \<30 ml/min)
Neisseria meningitidis infection that is not resolved
Current treatment with a complement inhibitor
Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening
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.
Chemotherapy for less than 3months
Pregnancy
Age \<18.
Clareo Health | A Study of the C3 Inhibitor AMY-101 in Patients With ARDS Due to COVID-19 (SAVE)
