COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05123755

Vasomune Therapeutics, Inc.

Not reported

2021-11-17

Recruiting

RCT

Randomized

Sequential assignment

Blind label

multi-center

Treatment

inclusion criteria: able and willing to give signed informed consent patients hospitalized with a presumed diagnosis of pneumonia of < 48 hours duration requiring supplemental oxygen therapy. eligible patients include those hospitalized for a separate non-infectious reason who subsequently develop a presumed pneumonia; radiologic imaging (chest x-ray, ct scan, etc.) evidence of pulmonary involvement with new and persistent or progressive and persistent infiltrate, consolidation or cavitation. signs and symptoms: at least 1 of the following signs: respiratory rate > 30 breaths/min; fever (> 38.0ºc or > 100.4o f); leukopenia (≤ 4,000 wbc/mm3 or leukocytosis (≥ 12,000 wbc/mm3); adults ≥ 70 years of age; altered mental status with no other recognized cause; and at least 1 of the following symptoms: new onset of purulent sputum or change in character of sputum or increased respiratory secretions; new onset or worsening cough, or dyspnea, or tachypnea; rales or bronchial breath sounds; female patients of reproductive potential must be on an effective contraceptive method

pregnant and/or lactating women patients included in any other interventional trial 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 including but not limited to: septic shock as defined by systolic blood pressure (sbp) < 90 mmhg or diastolic blood pressure (dbp) of < 60 mmhg; multiple organ failure; are moribund irrespective of the provision of treatments; any significant bleeding disorder or vasculitis; any serious, nonhealing wound, peptic ulcer or bone fracture; liver cirrhosis; history of a hypertensive crisis or hypertensive encephalopathy, or current, poorly controlled hypertension or hypotension; severe renal insufficiency or end stage renal disease as determined by estimated glomerular filtration rate <30ml/min/1.73m2; ards risk factors of aspiration pneumonia, non-cardiac shock, trauma, blood transfusion or drug overdose. 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

2

Vasomune Therapeutics, Inc.

18

100

United States

Severe disease at enrollment

6: Severe disease at enrollment

120

Safety and tolerability of multiple doses of IV administrations of AV-001 Injection compared with AV-001 placebo Injection in hospitalized patients with pneumonia due to COVID-19 and/or other respiratory infections.

None

Phase 2

[{"arm_notes": "", "treatment_id": 2065, "treatment_name": "Av-001", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]