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

ConditionsARDSCovid19Influenza, Human
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAVM Biotechnology Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Must have laboratory confirmed COVID-19;

Requires invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) despite standard of care rescue measures (eg, prone positioning, and/or PEEP ladder, and/or inhaled pulmonary vasodilators, and/or recruitment maneuvers and/or neuromuscular blockade);

Females of childbearing potential must have a negative serum pregnancy test at screening;

Disqualifiers

Moribund patient who, in the opinion of the Investigator, is not expected to survive at least 24 hours;

Known hypersensitivity or allergy to the study drug or any of its excipients;

D-dimer level >3 times above normal range;

Known gastric or duodenal ulcer;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AVM0703

    Drug

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

  • Placebo

    Drug

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

Treatment groups

16 Participants
are divided into 4 treatment groups
Group A: AVM0703 COVID-19 ARDS - activeActive comparator 1 intervention
Group B: Placebo COVID-19 ARDS - placeboPlacebo comparator 1 intervention
Group C: AVM0703 Influenza ARDS - activeActive comparator 1 intervention
Group D: AVM0703 Influenza ARDS - placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicities

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.

Time frame
0-12 months
2

28 day all-cause mortality will be a primary end point for Phase 1 and 2

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.

Time frame
0-12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AVM Biotechnology Inc

Lead sponsor

Medpace, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: