Study to Assess Efficacy and Safety Relative to Standard of Care in Patients With COVID-19 Pneumonia

Study Overview
=================
Brief Summary
-----------------
To assess the clinical efficacy of ANG-3777 relative to the standard of care in reducing the severity and progression of pulmonary and renal dysfunction and mortality in adult patients hospitalized with COVID-19 pneumonia

Official Title
-----------------
A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of ANG- 3777 in Patients Hospitalized With Confirmed COVID-19 Pneumonia

Conditions
-----------------
COVID-19, Pneumonia

Intervention / Treatment
-----------------
* Drug: Standard of Care (SOC) + ANG-3777
* Drug: Standard Of Care (SOC) + Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is a male or nonpregnant female 18 years of age or older. Patient has a positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 in a respiratory tract sample during the current hospital admission. Patient has pneumonia confirmed by chest imaging. Patient has moderate to severe disease based on the WHO disease severity scale assessment at the time of randomization defined as: Score 4, only those with FiO2 > 40% Score 5 (Non-invasive ventilation or high-flow oxygen) Patient has ability to provide informed consent signed by study patient or legally acceptable representative. Patient has willingness and ability to comply with study-related procedures/assessments Exclusion Criteria: Has an active malignancy or history of solid or hematological malignancies within 5 years prior to enrollment in the study. Patients who had basal or squamous cell carcinoma-in-situ of the skin that was diagnosed > 2 years prior to the study enrollment and not currently being treated are eligible for study enrollment. Patient is pregnant or breast-feeding. Patient, in the opinion of the investigator, is unlikely to survive for ≥48 hours from the time of screening. Patient has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study. Patient with alanine aminotransferase (ALT) or aspartate transaminase (AST) > 3x upper limit of normal (ULN) and/or total bilirubin > 2xULN at baseline Patient requires treatment with the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin (Cipro®) and/or fluvoxamine (Luvox®) Patients participating in any other clinical trial with an investigational drug product or procedure Recipients of solid organ and/or hematopoietic cell transplantation Patient is known to have End Stage Renal Disease (ESRD) and was being treated with maintenance hemodialysis or peritoneal dialysis prior to the current hospitalization. Note: Patients who initiated RRT due to Acute Kidney Injury during their current hospitalization will be eligible for the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ANG-3777 + SOC<br>ANG-3777 Administered IV for 30 min and SOC Repeat within 24 hours after previous dosing for a total of 4 days | Drug: Standard of Care (SOC) + ANG-3777<br>* Standard of Care (SOC) + ANG-3777<br>* Other names: Hepatocyte growth factor mimetic;|
| Placebo Comparator: Standard of Care + Placebo<br>Standard of Care + Placebo | Drug: Standard Of Care (SOC) + Placebo<br>* Standard Of Care + Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients alive, without the need for mechanical ventilation and free of the need for RRT (on an ongoing basis) at Day 28 |  | From the time of randomization until (Day 1) until death or until Day28, whichever comes first | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, Respiratory Failure, AKI, COVID-19, Acute Lung Injury, Acute Respiratory Distress Syndrome