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

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Angion Biomedica Corp
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Updated on 5 August 2020
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pneumonia
renal impairment
covid-19
SARS
chest imaging
acute respiratory syndrome (sars)

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

Details
Condition Pulmonary Disease, Upper respiratory infection, Pneumonia, Pneumonia, Covid 19
Age 18years - 100years
Treatment Standard of Care (SOC) + ANG-3777, Standard Of Care (SOC) + Placebo
Clinical Study IdentifierNCT04459676
SponsorAngion Biomedica Corp
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patient is a male or nonpregnant female 18 years of age or older
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
Patient has pneumonia confirmed by chest imaging
Patient has score of 5 on the WHO's disease severity scale assessment 8-point Ordinal Scale at the time of randomization
Patient has ability to provide informed consent signed by study patient or legally acceptable representative
Patient has willingness and ability to comply with study-related procedures/assessments

Exclusion Criteria

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
Patient is pregnant or breast-feeding
Patient, in the opinion of the investigator, is unlikely to survive for 48 hours from the time of screening
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
Patient with alanine aminotransferase (ALT) or aspartate transaminase (AST) > 3x upper limit of normal (ULN) and/or total bilirubin > 2xULN at baseline
Patient requires treatment with the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin (Cipro) and/or fluvoxamine (Luvox)
Patients participating in any other clinical trial with an investigational drug product or procedure
Recipients of solid organ and/or hematopoietic cell transplantation
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
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