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

Phase 2

• Conditions: COVID-19; Pneumonia
• Interventions: Drug: Standard of Care (SOC) + ANG-3777; Drug: Standard Of Care (SOC) + Placebo

• Registration Number: NCT04459676
• Lead Sponsor: Angion Biomedica Corp

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-07
• Study Start: 2020-07-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-15
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANG-3777 + SOC	Standard of Care (SOC) + ANG-3777	ANG-3777 Administered IV for 30 min and SOC Repeat within 24 hours after previous dosing for a total of 4 days
Standard of Care + Placebo	Standard Of Care (SOC) + Placebo	Standard of Care + Placebo

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP); 🇧🇷 Ribeirão Preto, Brazil

Pontifícia Universidade Catolica de Campinas; 🇧🇷 Campinas, Sao Paulo, Brazil

UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu; 🇧🇷 Botucatu, Brazil

Hospital Alemao Oswaldo Cruz; 🇧🇷 São Paulo, Brazil

Hospital Vila Nova Star; 🇧🇷 Sao Paulo, Brazil

Irmandade da Santa Casa de Misericórdia de São; 🇧🇷 Sao Paulo, Brazil

Santa Casa de Misericordia de Sao Paulo; 🇧🇷 São Paulo, Brazil

Hospital Heliópolis-SP; 🇧🇷 São Paulo, Brazil

Santa Casa de Misericórdia de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Vera Cruz - NUPEC Nucleo de Pesquisa Clínica; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil