NCT04395456

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Amyndas Pharmaceuticals S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	AMY-101	C3 complement inhibitor
OTHER	WFI 5% glucose	Placebo

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2020-05-20
• Last updated: 2021-02-21

Regulatory

• FDA-regulated drug study