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.
Drug: AMY-101
C3 complement inhibitor
Other: WFI 5% glucose
Placebo
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.