Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
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
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
Treatments tested in this trial
- AVM0703
- Placebo
Treatment groups
16 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
AVM Biotechnology Inc
Lead sponsor
Medpace, Inc.
Collaborator
Source ClinicalTrials.gov