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

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

Recruiting
18 years and older
All
Phase 2

Overview

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

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 score of 5 on the WHO's disease severity scale assessment 8-point Ordinal Scale at the time of randomization.
  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 details
    Pulmonary Disease
    Upper respiratory infection
    Pneumonia
    Pneumonia
    Covid 19

NCT04459676

Angion Biomedica Corp

5 August 2020

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