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

Sponsor

Angion Biomedica Corp (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04459676

Collaborator

CTI Clinical Trial and Consulting Services (Other)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia	Drug: Standard of Care (SOC) + ANG-3777 Drug: Standard Of Care (SOC) + Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 31, 2020

Anticipated Primary Completion Date :

Apr 30, 2021

Anticipated Study Completion Date :

Apr 30, 2021

Arms and Interventions

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: BB3 Hepatocyte growth factor mimetic
Placebo Comparator: Standard of Care + Placebo Standard of Care + Placebo	Drug: Standard Of Care (SOC) + Placebo Standard Of Care + Placebo

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:

BB3

Hepatocyte growth factor mimetic

Placebo Comparator: Standard of Care + Placebo

Standard of Care + Placebo

Drug: Standard Of Care (SOC) + Placebo

Standard Of Care + Placebo

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Vera Cruz - NUPEC Nucleo de Pesquisa Clínica	Belo Horizonte	Minas Gerais	Brazil
2	Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil
3	Pontifícia Universidade Catolica de Campinas	Campinas	Sao Paulo	Brazil
4	UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu	Botucatu		Brazil
5	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)	Ribeirão Preto		Brazil
6	Hospital Vila Nova Star	Sao Paulo		Brazil
7	Irmandade da Santa Casa de Misericórdia de São	Sao Paulo		Brazil
8	Hospital Alemao Oswaldo Cruz	São Paulo		Brazil
9	Hospital Heliópolis-SP	São Paulo		Brazil
10	Santa Casa de Misericordia de Sao Paulo	São Paulo		Brazil