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

NCT04366115 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-10-02

No results posted yet for this study

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.

Conditions

  • ARDS
  • Covid19
  • Influenza, Human

Interventions

DRUG

AVM0703

Single IV infusion at 10 mg/mL in normal saline over 1 hour to patients.

DRUG

Placebo

Single IV infusion in normal saline over 1 hour to patients.

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • AVM Biotechnology Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2031-12-01
Completion
2032-03-01
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04366115 on ClinicalTrials.gov