Status:
UNKNOWN
A Study of the C3 Inhibitor AMY-101 in Patients With ARDS Due to COVID-19 (SAVE)
Lead Sponsor:
Amyndas Pharmaceuticals S.A.
Conditions:
Acute Respiratory Distress Syndrome Due to SARS-CoV-2 Infection (Severe COVID19)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- Diagnosed with Acute Respiratory Distress Syndrome due to SARS-CoV-2 infection (severe Covid-19), according to the following criteria:
- Demonstration of SARS-CoV-2 RNAemia in nasopharyngeal swap or bronchio-alveolar lavage (BAL)
- 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);
- 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
- 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.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04395456
Start Date
September 1 2021
End Date
December 1 2022
Last Update
February 21 2021
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