Clinical trial NCT04459676: Study to Assess Efficacy and Safety Relative to Standard of Care in Patients With COVID-19 Pneumonia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Pneumonia
Keywords: COVID-19
Acute Lung Injury
Acute Respiratory Distress Syndrome
Pneumonia
Respiratory Failure
AKI
Lead sponsor: Angion Biomedica Corp
Sponsor class: INDUSTRY
Collaborators: name: CTI Clinical Trial and Consulting Services
First posted: 2020-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Proportion of patients alive, without the need for mechanical ventilation and free of the need for RRT (on an ongoing basis) at Day 28
timeFrame: From the time of randomization until (Day 1) until death or until Day28, whichever comes first
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital Vera Cruz - NUPEC Nucleo de Pesquisa Clínica
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Pontifícia Universidade Catolica de Campinas
state: Sao Paulo
city: Botucatu
country: Brazil
facility: UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)
city: Sao Paulo
country: Brazil
facility: Hospital Vila Nova Star
city: Sao Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São
city: São Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: São Paulo
country: Brazil
facility: Hospital Heliópolis-SP
city: São Paulo
country: Brazil
facility: Santa Casa de Misericordia de Sao Paulo
Study officials:
affiliation: Angion Biomedica
name: John Neylan, MD
role: STUDY_DIRECTOR
References: