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

Amyndas Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Acute Respiratory Distress Syndrome Due to SARS-CoV-2 Infection (Severe COVID19)

Treatments

Drug: AMY-101

Other: WFI 5% glucose

Study type

Interventional

Funder types

Industry

Identifiers

NCT04395456

AMY-101_SAVE

Details and patient eligibility

About

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.

Enrollment

144 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.