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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04459676
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Angion Biomedica Corp

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

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Standard of Care (SOC) + ANG-3777 Drug: Standard Of Care (SOC) + Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 31, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Active Comparator: ANG-3777 + SOC

ANG-3777 Administered IV for 30 min and SOC

Repeat within 24 hours after previous dosing for a total of 4 days

Drug: Standard of Care (SOC) + ANG-3777
Standard of Care (SOC) + ANG-3777
Other Names:
  • BB3
  • Hepatocyte growth factor mimetic

Placebo Comparator: Standard of Care + Placebo
Standard of Care + Placebo
Drug: Standard Of Care (SOC) + Placebo
Standard Of Care + Placebo




Primary Outcome Measures :
  1. Proportion of patients alive, without the need for mechanical ventilation and free of the need for RRT (on an ongoing basis) at Day 28 [ Time Frame: From the time of randomization until (Day 1) until death or until Day28, whichever comes first ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459676


Contacts
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Contact: Deb Gouveia 781-521-4286 dgouveia@angion.com
Contact: John Neylan, MD jneylan@angion.com

Locations
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Brazil
UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu Recruiting
Botucatu, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP) Recruiting
Ribeirão Preto, Brazil
Hospital Guilherme Alvaro Not yet recruiting
Santos, Brazil
Escola Paulista de Medicina (Universidade Federal de São Paulo) Not yet recruiting
São Paulo, Brazil
Hospital Alemao Oswaldo Cruz Recruiting
São Paulo, Brazil
Hospital Heliópolis-SP Not yet recruiting
São Paulo, Brazil
Santa Casa de Misericordia de Sao Paulo Not yet recruiting
São Paulo, Brazil
Sponsors and Collaborators
Angion Biomedica Corp
CTI Clinical Trial and Consulting Services
Investigators
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Study Director: John Neylan, MD Angion Biomedica
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Responsible Party: Angion Biomedica Corp
ClinicalTrials.gov Identifier: NCT04459676    
Other Study ID Numbers: ANG3777-ALI-201
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Angion Biomedica Corp:
COVID-19
Acute Lung Injury
Acute Respiratory Distress Syndrome
Pneumonia
Respiratory Failure
AKI
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action