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 range18 Years
SexALL
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
ā. Age ā„18 years;
ā. Must have laboratory confirmed COVID-19;
ā. Must have moderate or severe, immediately life-threatening COVID-19 or Influenza (A or B), as follows:
ā. 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);
ā. Females of childbearing potential must have a negative serum pregnancy test at screening;
ā. 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
ā. Capable of providing informed consent, or if not capable, a legally authorized representative is capable of providing informed consent
Exclusion criteria
ā. Moribund patient who, in the opinion of the Investigator, is not expected to survive at least 24 hours;
ā. Known hypersensitivity or allergy to the study drug or any of its excipients;
ā. D-dimer level \>3 times above normal range;
ā. Known gastric or duodenal ulcer;
ā
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
. Uncontrolled type 1 or type 2 diabetes, per judgment of the Investigator;
ā. 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;
ā. Positive testing for tuberculosis during screening;
ā. Known to have received a live vaccine within the previous 1 month;