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

NCT ID: NCT04459676

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2021-04-30

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

Conditions

COVID-19; Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC) + ANG-3777

Intervention Type: DRUG

Standard of Care (SOC) + ANG-3777

Standard of Care + Placebo

Standard of Care + Placebo

Group Type: PLACEBO_COMPARATOR

Standard Of Care (SOC) + Placebo

Intervention Type: DRUG

Standard Of Care + Placebo

Interventions

Standard of Care (SOC) + ANG-3777

Standard of Care (SOC) + ANG-3777

Intervention Type: DRUG

Standard Of Care (SOC) + Placebo

Standard Of Care + Placebo

Intervention Type: DRUG

Other Intervention Names

BB3; Hepatocyte growth factor mimetic

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CTI Clinical Trial and Consulting Services

OTHER

Sponsor Role: collaborator

Angion Biomedica Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Neylan, MD

Role: STUDY_DIRECTOR

Angion Biomedica

Locations

Hospital Vera Cruz - NUPEC Nucleo de Pesquisa Clínica

Belo Horizonte, Minas Gerais, Brazil

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Pontifícia Universidade Catolica de Campinas

Campinas, São Paulo, Brazil

UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu

Botucatu, , Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)

Ribeirão Preto, , Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, , Brazil

Hospital Heliópolis-SP

São Paulo, , Brazil

Hospital Vila Nova Star

São Paulo, , Brazil

Irmandade da Santa Casa de Misericórdia de São

São Paulo, , Brazil

Santa Casa de Misericordia de Sao Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

ANG3777-ALI-201

Identifier Type: -

Identifier Source: org_study_id