A Study of the C3 Inhibitor AMY-101 in Patients With ARDS Due to COVID-19 (SAVE)

A Phase 2 Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor, AMY-101, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 (SAVE)

The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of AMY-101, a potent C3 inhibitor, for the management of patients with ARDS caused by SARS-CoV-2 infection.

We will assess the efficacy and safety, as well as pharmacokinetics (PK), and pharmacodynamics (PD). The study will assess the impact of AMY-101 in patients with severe COVID19; specifically, it will assess the impact of AMY-101 1) on survival without ARDS and without oxygen requirement at day 21 and 2) on the clinical status of the patients at day 21.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.