Condition: Acute Respiratory Distress Syndrome · Viral or Bacterial Infections · Pneumonia · Sponsor: Vasomune Therapeutics, Inc.
A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy. The purpose of this study is to examine the safety, tolerability and efficacy of AV-001 Injection administration daily to the earlier of day 28 or EOT (day prior to hospital discharge). A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) will be recruited from up to 25 participating institutions/hospitals. Patients will be randomized in a 1:1 ratio to receive either AV-001 Injection or AV-001 placebo Injection, together with standard of care (SOC).
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Hoag Memorial Hospital Presbyterian | Newport Beach, California, United States | Recruiting |
| Denver Health Medical Center | Denver, Colorado, United States | Recruiting |
| MedStar Health Research Institute, Inc. | Hyattsville, Maryland, United States | Recruiting |
| Henry Ford Health System | Detroit, Michigan, United States | Recruiting |
| The Ohio State University | Columbus, Ohio, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05123755