AV-001 for Hospitalized Patients With COVID-19 Disease

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation study in patients hospitalized with confirmed severe coronavirus disease 2019 (COVID-19). 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) to patients with severe COVID-19 disease. 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 20 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vasomune Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Able and willing to give signed informed consent

• Hospitalized less than 48 hours with pneumonia and confirmed COVID-19 disease

• Meet the criteria for severe COVID_19 disease at randomization defined as patients that have one or more of the following:

• oxygen saturation as detected by pulse oximeter (SpO2) < 94% on room air at sea level

• ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mm Hg

• respiratory rate > 30 breaths/min

• lung infiltrates involving > 50% of lung parenchyma

• Score of 5 or 6 on the WHO COVID-19 10-point Clinical Progression Scale (CPS) at randomization

• Female patients of reproductive potential must be on an effective contraceptive method

Exclusion Criteria:

• Pregnant and/or lactating women

• Patients included in any other interventional trial

• Body Mass Index (BMI) > 35

• Use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at screening

• Any concurrent serious medical condition or concomitant medication that would preclude participation in the study

• Known history of human immunodeficiency virus and/or hepatitis (acute or chronic)

• Severe renal insufficiency or end-stage renal disease

• Recent (within past 2 months) major surgery or central venous access device placement

• Any thromboembolic event within the past 3 months

• Symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia > class II as per New York Heart Association (NYHA) classification

• History of autonomic disorders or uncontrolled hypotension

• Hypersensitivity to drug products containing polyethylene glycol (PEG)

• Any other condition which the Principal Investigator feels may jeopardize the safety of the patient or the objectives of the study