COVID-19, Pneumonia
Conditions
Keywords
COVID-19, Acute Lung Injury, Acute Respiratory Distress Syndrome, Pneumonia, Respiratory Failure, AKI
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
Interventions
DRUGStandard of Care (SOC) + ANG-3777
Standard of Care (SOC) + ANG-3777
DRUGStandard Of Care (SOC) + Placebo
Standard Of Care + Placebo
Sponsors
CTI Clinical Trial and Consulting Services
Angion Biomedica Corp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed