Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS

Phase 1

Not yet recruiting

• Conditions: ARDS; Covid19; Influenza, Human
• Interventions: Drug: Placebo; Drug: AVM0703

• Registration Number: NCT04366115
• Lead Sponsor: AVM Biotechnology Inc

Brief Summary

This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered as a single intravenous (IV) infusion to patients with moderate or severe immediately life-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza (A or B). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose of AVM0703 in these ARDS patients.

Detailed Description

The primary objective of the study is to evaluate the safety and tolerability of a single dose of AVM0703 in patients with moderate, severe or immediately life-threatening ARDS due to COVID-19 or Influenza (A or B) infection.

The secondary objectives of the study are to 1) evaluate the pharmacokinetics (PK) and 2) evaluate potential clinical findings following a single dose of AVM0703.

The exploratory objective of the study is to assess potential biomarkers indicative of natural killer T (NKT) cell activity and biomarkers predictive of response to AVM0703 in peripheral blood and bronchoalveolar lavage.

The results of the Phase 1 study will guide the design of the Phase 2 study.

Study Timeline

• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Start: 2024-12-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo COVID-19 ARDS - placebo	Placebo	Matching placebo
AVM0703 Influenza ARDS - active	AVM0703	Supra-pharmacologic dexamethasone sodium phosphate
AVM0703 Influenza ARDS - placebo	Placebo	Matching placebo
AVM0703 COVID-19 ARDS - active	AVM0703	Supra-pharmacologic dexamethasone sodium phosphate

Primary Outcome Measures

Name	Time	Method
28 day all-cause mortality will be a primary end point for Phase 1 and 2	0-12 months	The primary endpoint of the Phase 1/2 portion of the study is to evaluate the efficacy of AVM0703 in subjects with severe or life-threatening COVID-19 infection.
Dose-Limiting Toxicities	0-12 months	The primary endpoint of the Phase 1 portion of the study is to evaluate the safety of AVM0703 in subjects with severe or life-threatening COVID-19 infection, and to identify the RP2D.