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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04459676
• Other study ID #: ANG3777-ALI-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 31, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2021
• Source: Angion Biomedica Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

Drug:
• Standard of Care (SOC) + ANG-3777
Standard of Care (SOC) + ANG-3777
• Standard Of Care (SOC) + Placebo
Standard Of Care + Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Angion Biomedica Corp	CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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