Clinical trial NCT04634409: A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
Official title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: AbCellera Biologics Inc.
name: Shanghai Junshi Bioscience Co., Ltd.
name: GlaxoSmithKline
name: Vir Biotechnology, Inc.
First posted: 2020-11-18
Enrollment: 1755
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.


Eligibility criteria: Inclusion Criteria:

* For low-risk participant arms 9-11 only: Are greater than or equal to (≥)18 and less than (\<)65 years of age at the time of randomization and do not have the risk factors defined in the bullet point directly below
* For high-risk participant arms 12 and 13 only:

  -- Are ≥18 years of age and satisfy at least one of the following risk factors at the time of screening
  * Are ≥65 years of age
  * Have a body mass index (BMI) ≥ 35
  * Have chronic kidney disease
  * Have type 1 or type 2 diabetes
  * Have immunosuppressive disease
  * Are currently receiving immunosuppressive treatment, or
  * Are ≥55 years of age AND have

    * cardiovascular disease, OR
    * hypertension, OR
    * chronic obstructive pulmonary disease or other chronic respiratory disease
* For high-risk participant arms 12 and 13 only:

  * Are 12-17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening

    * Have a BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm
    * Have sickle cell disease
    * Have congenital or acquired heart disease
    * Have neurodevelopmental disorders, for example, cerebral palsy
    * Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
    * Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control
    * Have type 1 or type 2 diabetes
    * Have chronic kidney disease
    * Have immunosuppressive disease, or
    * Are currently receiving immunosuppressive treatment.

For high-risk participants arm 14 only:

* Are ≥12 years of age and satisfy at least one of the following risk factors at the time of screening Are ≥65 years of age
* Are adults (≥18 years of age) with BMI \>25 kg/m2 , or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts
* Have chronic kidney disease
* Have type 1 or type 2 diabetes
* Have immunosuppressive disease
* Are currently receiving immunosuppressive treatment
* Have cardiovascular disease (including congenital heart disease) or hypertension
* Have chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma \[moderate-to-severe\], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
* Have sickle cell disease
* Have neurodevelopmental disorder (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
* Have a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation \[not related to COVID-19\]
* Are currently not hospitalized
* Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion, nasal congestion or runny nose, new loss of smell, chills
* Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
* Are men or non-pregnant women who agree to contraceptive requirements
* Understand and agree to comply with planned study procedures
* Agree to the collection of nasopharyngeal swabs and venous blood
* The participant or legally authorized representative give signed informed consent and/or assent

Exclusion Criteria:

* For low-risk participants only: BMI ≥35
* Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) \<300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
* Require mechanical ventilation or anticipated impending need for mechanical ventilation
* Have known allergies to any of the components used in the formulation of the interventions
* Have hemodynamic instability requiring use of pressors within 24 hours of randomization
* Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
* Have any co-morbidity requiring surgery within \<7 days, or that is considered life-threatening within 29 days
* Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
* Have a history of a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test prior to the one serving as eligibility for this study
* Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
* Have received treatment with a SARS-CoV-2 specific monoclonal antibody
* Have a history of convalescent COVID-19 plasma treatment
* For low-risk arms only: have received a SARS-CoV-2 vaccine or have participated in a previous SARS-CoV-2 vaccine study and are currently blinded to treatment allotment
* Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
* Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Are pregnant or breast feeding
* Are investigator site personnel directly affiliated with this study
* Have body weight \<40 kilograms

Primary outcomes:
measure: Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27
timeFrame: Day 7
measure: Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
timeFrame: Day 7
measure: Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
timeFrame: Day 7
Secondary outcomes:
measure: Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
timeFrame: Day 7
measure: Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
timeFrame: Day 7
measure: Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
timeFrame: Day 7
measure: Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
timeFrame: Day 7
measure: Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
timeFrame: Day 7
measure: Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
timeFrame: Baseline through Day 29
measure: Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
timeFrame: Baseline through Day 29
measure: Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
timeFrame: Baseline through Day 29
measure: Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
timeFrame: Baseline through Day 29
measure: Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
timeFrame: Baseline through Day 29
measure: Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
timeFrame: Baseline, Day 7
measure: Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
timeFrame: Baseline, Day 7
measure: Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
timeFrame: Baseline, Day 7
measure: Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
timeFrame: Baseline, Day 7
measure: Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
timeFrame: Baseline, Day 7
measure: Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
timeFrame: Baseline, Day 7
measure: Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
timeFrame: Baseline, Day 7
measure: Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
timeFrame: Baseline, Day 7
measure: Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution
timeFrame: Day 7
measure: Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution
timeFrame: Day 7
measure: Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
timeFrame: Day 7
measure: Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
timeFrame: Day 7
measure: Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution
timeFrame: Day 7
measure: Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement
timeFrame: Day 7
measure: Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement
timeFrame: Day 7
measure: Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
timeFrame: Day 7
measure: Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
timeFrame: Day 7
measure: Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement
timeFrame: Day 7
measure: Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
timeFrame: Baseline through Day 29
measure: Treatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
timeFrame: Baseline through Day 29
measure: Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
timeFrame: Baseline through Day 29
measure: Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
timeFrame: Baseline through Day 29
measure: Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
timeFrame: Baseline through Day 29
measure: Pharmacokinetics (PK): Mean Concentration of Bamlanivimab
timeFrame: Day 29
measure: Pharmacokinetics (PK): Mean Concentration of Etesevimab
timeFrame: Day 29
measure: Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
timeFrame: Day 29
measure: Pharmacokinetics (PK): Mean Concentration of VIR-7831
timeFrame: Day 29
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mesa
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center
state: Arizona
city: Sun City West
country: United States
facility: CRI of Arizona, LLC
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine PC
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Little Rock
country: United States
facility: KLR Business Group, Inc. dba Arkansas Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Applied Rsch Ctr - Arkansas Inc.
state: Arkansas
city: Anaheim
country: United States
facility: Smart Cures Clin Research
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Covina
country: United States
facility: VCT-Covina
state: California
city: Escondido
country: United States
facility: Neighborhood Healthcare
state: California
city: Lancaster
country: United States
facility: Chemidox Clinical Trials
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials LLC
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Modesto
country: United States
facility: Central Valley Research, LLC
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Sacramento
country: United States
facility: Sutter Institute For Medical Research
state: California
city: Santa Ana
country: United States
facility: Wolverine Clinical Trials, LLC
state: California
city: Santa Rosa
country: United States
facility: St. Joe Heritage HC-Santa Rosa
state: California
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
city: Thousand Oaks
country: United States
facility: Mazur, Statner, Dutta, Nathan
state: California
city: Torrance
country: United States
facility: South Bay Clinical Research Institute
state: California
city: Walnut Creek
country: United States
facility: Infect Disease Doctors Med Grp
state: California
city: Westminster
country: United States
facility: Allianz Research Institute
state: California
city: Colorado Springs
country: United States
facility: Future Innovative Treatments LLC
state: Colorado
city: Washington
country: United States
facility: Georgetown Univ Sch of Med
state: District of Columbia
city: Bradenton
country: United States
facility: Synergy Healthcare LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Inc.
state: Florida
city: Hialeah
country: United States
facility: I R & Health Center, Inc.
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Hollywood
country: United States
facility: Elixia CRC
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami
country: United States
facility: Hope Clinical Trials, Inc.
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc.
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners, LLC d/b/a CSP Miami
state: Florida
city: Sunrise
country: United States
facility: Testing Matters Lab
state: Florida
city: Tampa
country: United States
facility: Advent Health Tampa
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Inst
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC DBA CSP Orlando
state: Florida
city: Buford
country: United States
facility: Gwinnett Research Inst
state: Georgia
city: College Park
country: United States
facility: Paramount Rch Sol - College Pk
state: Georgia
city: Columbus
country: United States
facility: IACT Health - VHC
state: Georgia
city: Macon
country: United States
facility: Central Georgia Infectious Disease
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Dyer
country: United States
facility: Franciscan Health Hammond
state: Indiana
city: Evansville
country: United States
facility: Qualmedica Research Evansville
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Indianapolis
country: United States
facility: St.Vincent - Indy
state: Indiana
city: Owensboro
country: United States
facility: Qualmedica Research, LLC
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research,LLC
state: Louisiana
city: Moss Bluff
country: United States
facility: Imperial Health Urgent Care Center - Moss Bluff
state: Louisiana
city: New Orleans
country: United States
facility: Nola Research Works, LLC
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: U of MA Mem Med Ctr
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Farmington Hills
country: United States
facility: Revive Research Institute
state: Michigan
city: Sterling Heights
country: United States
facility: Revival Research Institute
state: Michigan
city: Fayette
country: United States
facility: Sky Clinical Prime and Health Wellness Clinic
state: Mississippi
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Ridgeland
country: United States
facility: Sky Clin Resch - Quinn HC
state: Mississippi
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Las Vegas
country: United States
facility: SVG Clinical
state: Nevada
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Prime Global Research, LLC
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions, LLC
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomed Research
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Primary Care
state: Ohio
city: Cincinnati
country: United States
facility: Hometown UC and Rch- Cincy
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Columbus
country: United States
facility: Urgent Care Specialists, LLC
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Inc
state: Ohio
city: Dayton
country: United States
facility: Urgent Care Specialists, LLC
state: Ohio
city: Dayton
country: United States
facility: META Medical Research Institute
state: Ohio
city: Tulsa
country: United States
facility: Ascension St. John Tulsa OK
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Hosp for Neurosci
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Anderson
country: United States
facility: VITALINK - Anderson
state: South Carolina
city: Clinton
country: United States
facility: Carolina Medical Research - Clinton
state: South Carolina
city: Gaffney
country: United States
facility: VITALINK - Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Carolina Medical Research - Greenville
state: South Carolina
city: Greenville
country: United States
facility: VITALINK - Greenville
state: South Carolina
city: Spartanburg
country: United States
facility: VITALINK - Spartanburg
state: South Carolina
city: Union
country: United States
facility: VITALINK - Union
state: South Carolina
city: Chattanooga
country: United States
facility: Univ Diab & Endo Consult
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Beaumont
country: United States
facility: Gadolin Research, LLC
state: Texas
city: Conroe
country: United States
facility: Conroe Willis Medical Research
state: Texas
city: Corpus Christi
country: United States
facility: Crossroads Clinical Research
state: Texas
city: Dallas
country: United States
facility: B S & W Med Center
state: Texas
city: Fort Worth
country: United States
facility: Baylor - Fort Worth
state: Texas
city: Fort Worth
country: United States
facility: North Texas Clinical Trials, LLC
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Ins
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management, LLC.
state: Texas
city: Houston
country: United States
facility: 1960 Family Practice, PA
state: Texas
city: Irving
country: United States
facility: B S & W Med Center
state: Texas
city: Katy
country: United States
facility: Zion Urgent Care Clinic
state: Texas
city: McAllen
country: United States
facility: BioPharma Family Practice Center McAllen
state: Texas
city: McAllen
country: United States
facility: BRCR Medical Center, Inc
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Medical Research
state: Texas
city: Pasadena
country: United States
facility: Bay Area Infectious Diseases Associates
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research
state: Texas
city: Round Rock
country: United States
facility: Baylor - Round Rock
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Splendora
country: United States
facility: APD Clinical Research
state: Texas
city: Victoria
country: United States
facility: Crossroads Clin Rch-Victoria
state: Texas
city: Webster
country: United States
facility: CLS Research Ctr, PLLC
state: Texas
city: Annandale
country: United States
facility: CARE ID
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Health Research
state: Washington
city: Ciudad de Buenos Aires
country: Argentina
facility: Sanatorio Sagrado Corazón
state: AR
city: Ciudad de Buenos Aires
country: Argentina
facility: Clínica Zabala
state: AR
city: Caba
country: Argentina
facility: Sanatorio de la Trinidad Mitre
state: Buenos Aires
city: Munro
country: Argentina
facility: Clínica Privada Independencia
state: Buenos Aires
city: San Nicolás
country: Argentina
facility: Go Centro Medico San Nicolás
state: Buenos Aires
city: Zárate
country: Argentina
facility: Instituto de Investigaciones Clinicas Zarate
state: Buenos Aires
city: Rio Cuarto
country: Argentina
facility: Instituto Médico Rio Cuarto
state: Cordoba
city: Villa Regina
country: Argentina
facility: Clinica Central S.A.
state: Rio Negro
city: Viedma
country: Argentina
facility: Centro de Investigaciones Clínicas - Clínica Viedma
state: RN
city: Rosario
country: Argentina
facility: INECO Neurociencias Oroño
state: Santa Fe
city: Cordoba
country: Argentina
facility: Hospital San Roque
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: Dorado
country: Puerto Rico
facility: Dorado Medical Complex Inc
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
citation: Nathan R, Shawa I, De La Torre I, Pustizzi JM, Haustrup N, Patel DR, Huhn G. A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2. Infect Dis Ther. 2021 Dec;10(4):1933-1947. doi: 10.1007/s40121-021-00515-6. Epub 2021 Aug 10.