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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Pneumonia
• Intervention / Treatment: Drug: Standard of Care (SOC) + ANG-3777; Drug: Standard Of Care (SOC) + Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Botucatu, Brazil
    • UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu
  • Ribeirão Preto, Brazil
    • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)
  • Sao Paulo, Brazil
    • Hospital Vila Nova Star
  • Sao Paulo, Brazil
    • Irmandade da Santa Casa de Misericórdia de São
  • São Paulo, Brazil
    • Hospital Alemão Oswaldo Cruz
  • São Paulo, Brazil
    • Hospital Heliópolis-SP
  • São Paulo, Brazil
    • Santa Casa de Misericordia de Sao Paulo
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Hospital Vera Cruz - NUPEC Nucleo de Pesquisa Clínica
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Santa Casa de Misericordia de Porto Alegre
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil
      • Pontifícia Universidade Catolica de Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is a male or nonpregnant female 18 years of age or older.
2. 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.
3. Patient has pneumonia confirmed by chest imaging.

4. 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)
5. Patient has ability to provide informed consent signed by study patient or legally acceptable representative.
6. Patient has willingness and ability to comply with study-related procedures/assessments

Exclusion Criteria:

1. 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.
2. Patient is pregnant or breast-feeding.
3. Patient, in the opinion of the investigator, is unlikely to survive for ≥48 hours from the time of screening.
4. 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.
5. Patient with alanine aminotransferase (ALT) or aspartate transaminase (AST) > 3x upper limit of normal (ULN) and/or total bilirubin > 2xULN at baseline
6. Patient requires treatment with the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin (Cipro®) and/or fluvoxamine (Luvox®)
7. Patients participating in any other clinical trial with an investigational drug product or procedure
8. Recipients of solid organ and/or hematopoietic cell transplantation
9. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ANG-3777 + SOC; 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; Standard of Care (SOC) + ANG-3777; Other Names: Hepatocyte growth factor mimetic; BB3
Placebo Comparator: Standard of Care + Placebo	Drug: Standard Of Care (SOC) + Placebo; Standard Of Care + Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Angion Biomedica Corp
• Collaborators: CTI Clinical Trial and Consulting Services
• Investigators: Study Director: John Neylan, MD, Angion Biomedica

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pneumonia; COVID-19; Acute Respiratory Distress Syndrome; Respiratory Failure; Acute Lung Injury; AKI
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: ANG3777-ALI-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes