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

NCT04395456 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: AMY-101_SAVE
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• The proportion of patients who are alive, without evidence of ARDS (i.e. PaO2/FIO2 >300 mm Hg), who do not require any oxygen support (in room air).

  21 days

• The proportion of patients assigned to each category, of a six-category ordinal scale.

  The clinical status is based on the following six-category ordinal scale: * 1: not hospitalised; * 2: hospitalised, not requiring supplemental oxygen; * 3: hospitalised, requiring supplemental oxygen; * 4: hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; * 5: hospitalised, requiring ECMO, invasive mechanical ventilation, or both; and * 6: death.

  21 days

Secondary Outcomes (21)

• The proportion of patients assigned to each category, of a six-category ordinal scale.

  On days 7, 14, and 44

• Proportion of patients surviving

  Through to day 44

• Proportion of respiratory failure-free survival

  Day 44

• Cumulative incidence of resolution of ARDS (defined as PaO2/FiO2 ≥200 in room air)

  Through day 44

• Cumulative incidence of freedom from oxygen requirement

  Through day 44

Study Arms (2)

AMY-101

EXPERIMENTAL

Drug: AMY-101

Placebo

PLACEBO COMPARATOR

Other: WFI 5% glucose

Interventions

AMY-101 DRUG

C3 complement inhibitor

AMY-101

WFI 5% glucose OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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.

Sponsors & Collaborators

• Amyndas Pharmaceuticals S.A.: lead

Related Publications (2)

• Risitano AM, Mastellos DC, Huber-Lang M, Yancopoulou D, Garlanda C, Ciceri F, Lambris JD. Complement as a target in COVID-19? Nat Rev Immunol. 2020 Jun;20(6):343-344. doi: 10.1038/s41577-020-0320-7. Epub 2020 Apr 23.

  PMID: 32327719 BACKGROUND

• Mastaglio S, Ruggeri A, Risitano AM, Angelillo P, Yancopoulou D, Mastellos DC, Huber-Lang M, Piemontese S, Assanelli A, Garlanda C, Lambris JD, Ciceri F. The first case of COVID-19 treated with the complement C3 inhibitor AMY-101. Clin Immunol. 2020 Jun;215:108450. doi: 10.1016/j.clim.2020.108450. Epub 2020 Apr 29.

  PMID: 32360516 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

AMY-101; Glucose

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 20, 2020
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02