Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS (NCT04366115) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
16 participantsStarted 2026-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years;
. Must have laboratory confirmed COVID-19;
. Must have moderate or severe, immediately life-threatening COVID-19 or Influenza (A or B), as follows:
. 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;
. Females of childbearing potential and nonsterile males must agree to use medically effective methods of contraception from the time of informed consent through 1 month after study drug infusion; and
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since AVM0703 is in Phase 1 and this trial hasn't started recruiting yet, what does that mean for how much is already known about its safety in people with ARDS from COVID-19 or influenza — and would it make sense to wait for earlier safety data before considering it?
2The trial is specifically measuring dose-limiting toxicities as a primary outcome, which means a key goal is figuring out how much of this drug is too much — given that I'm already critically ill with ARDS, how do you weigh that kind of uncertainty against my current treatment options?
3Because 28-day all-cause mortality is listed as a primary endpoint for this Phase 1 trial, does that suggest patients enrolled will be severely ill, and how does my specific situation compare to the kind of patients this trial is designed for?
4This trial targets ARDS caused by either COVID-19 or influenza — does the underlying cause of my ARDS affect whether this treatment might be relevant for me, and does my doctor think my case fits the profile the researchers are studying?
5Since the trial is not yet recruiting, are there other active trials or standard-of-care treatments for ARDS that my doctor would recommend I explore in the meantime, rather than waiting for this one to open?'
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-Limiting Toxicities
Timeframe: 0-12 months
2
28 day all-cause mortality will be a primary end point for Phase 1 and 2
. Capable of providing informed consent, or if not capable, a legally authorized representative is capable of providing informed consent
Exclusion criteria
. 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;
. Uncontrolled type 1 or type 2 diabetes, per judgment of the Investigator;
. Active and untreated bacterial, fungal, parasitic, or viral infection other than COVID-19 or Influenza (A or B). Patients with a history of a positive hepatitis B surface antigen and/or hepatitis B core antibody must have a negative hepatitis B polymerase chain reaction (PCR) assay result. Patients with history of a positive hepatitis C virus antibody test must have a negative hepatitis C PCR assay result;
. Positive testing for tuberculosis during screening;
. Known to have received a live vaccine within the previous 1 month;