Clinical trial NCT04426695: Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
Official title: A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
coronavirus
acute respiratory distress syndrome
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 2252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1/Phase 2/Phase 3
Primary purpose: TREATMENT

Brief summary: The primary objectives are:

Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)

* To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2
* To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation

Phase 1/2 (Cohort 1)

* To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
* To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo


Eligibility criteria: Key Inclusion Criteria:

* Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal \[OP\], or saliva) ≤72 hours prior to randomization and no alternative explanation for current clinical condition. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable.
* Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10 days before randomization
* Hospitalized for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:

  1. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
  2. Cohort 1: Maintains O2 saturation \>93% on low-flow oxygen as defined in the protocol
  3. Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol
  4. Cohort 3: On mechanical ventilation

Key Exclusion Criteria:

* Phase 1 Only: Patients maintaining O2 saturation \>94% on room air
* In the opinion of the investigator, unlikely to survive for \>48 hours from screening
* Receiving extracorporeal membrane oxygenation (ECMO)
* Has new-onset stroke or seizure disorder during hospitalization
* Initiated on renal replacement therapy due to COVID-19

NOTE: Other protocol defined inclusion / exclusion criteria apply

Primary outcomes:
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS
timeFrame: Day 1 to Day 7
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS
timeFrame: Day 6 to Day 29
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS
timeFrame: Day 6 to Day 29
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS
timeFrame: Day 6 to Day 29
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS
timeFrame: Day 1 to Day 29
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS
timeFrame: Day 1 to Day 29
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS
timeFrame: Day 1 to Day 29
measure: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events
timeFrame: Up to Day 169
measure: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4
timeFrame: Up to Day 4
measure: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29
timeFrame: Up to Day 29
measure: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS
timeFrame: Up to Day 29
measure: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS
timeFrame: Up to Day 29
Secondary outcomes:
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS
timeFrame: Day 6 to Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS
timeFrame: Day 6 to Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS
timeFrame: Day 1 to Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS
timeFrame: Day 1 to Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS
timeFrame: Up to Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS
timeFrame: by Day 29
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS
timeFrame: Up to Day 56
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS
timeFrame: Up to Day 56
measure: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events
timeFrame: Up to Day 169
measure: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4
timeFrame: Up to Day 4
measure: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29
timeFrame: Up to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS
timeFrame: by Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS
timeFrame: Day 6 to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS
timeFrame: Day 1 to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS
timeFrame: by Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS
timeFrame: Up to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS
timeFrame: Up to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS
timeFrame: by Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS
timeFrame: by Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS
timeFrame: Up to Day 56
measure: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS
timeFrame: Day 1 to Day 11
measure: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29
timeFrame: Day 1 to Day 29
measure: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time
timeFrame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
measure: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time
timeFrame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
timeFrame: by Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS
timeFrame: Day 6 to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS
timeFrame: Day 1 to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS
timeFrame: by Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS
timeFrame: Up to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS
timeFrame: Up to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS
timeFrame: Up to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS
timeFrame: Up to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS
timeFrame: Up to Day 56
measure: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS
timeFrame: Up to Day 29
measure: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS
timeFrame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
measure: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS
timeFrame: Through Day 29
measure: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
timeFrame: Through Day 29
measure: Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)
timeFrame: Up to Day 28
measure: Concentration at the End of Infusion (Ceoi)
timeFrame: Day 1
measure: Concentration at Day 28 (C28)
timeFrame: Day 28
measure: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
timeFrame: Through Day 169
measure: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
timeFrame: Through Day 169
measure: Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933
timeFrame: Through Day 57
measure: Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987
timeFrame: Through Day 57
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regeneron Study Site
state: Alabama
city: Chandler
country: United States
facility: Regeneron Study Site
state: Arizona
city: Phoenix
country: United States
facility: Regeneron Study Site
state: Arizona
city: Tucson
country: United States
facility: Regeneron Study Site 1
state: Arizona
city: Long Beach
country: United States
facility: Regeneron Study Site
state: California
city: Mission Hills
country: United States
facility: Regeneron Study Site
state: California
city: Sacramento
country: United States
facility: Regeneron Study Site
state: California
city: Santa Monica
country: United States
facility: Regeneron Study Site
state: California
city: Stanford
country: United States
facility: Regeneron Study Site
state: California
city: Aurora
country: United States
facility: Regeneron Study Site
state: Colorado
city: Boca Raton
country: United States
facility: Regeneron Study Site
state: Florida
city: Fort Pierce
country: United States
facility: Regeneron Study Site
state: Florida
city: Gainesville
country: United States
facility: Regeneron Study Site
state: Florida
city: Orlando
country: United States
facility: Regeneron Study Site
state: Florida
city: Pensacola
country: United States
facility: Regeneron Study Site
state: Florida
city: Sarasota
country: United States
facility: Regeneron Study Site
state: Florida
city: Tampa
country: United States
facility: Regeneron Study Site
state: Florida
city: Atlanta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Atlanta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Augusta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Marietta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Chicago
country: United States
facility: Regeneron Study Site
state: Illinois
city: Chicago
country: United States
facility: Regeneron Study Site
state: Illinois
city: Glenview
country: United States
facility: Regeneron Study Site
state: Illinois
city: Urbana
country: United States
facility: Regeneron Study Site
state: Illinois
city: Indianapolis
country: United States
facility: Regeneron Study Site
state: Indiana
city: Iowa City
country: United States
facility: Regeneron Study Site
state: Iowa
city: Louisville
country: United States
facility: Regeneron Study Site
state: Kentucky
city: Louisville
country: United States
facility: Regeneron Study Site
state: Kentucky
city: New Orleans
country: United States
facility: Regeneron Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Regeneron Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Regeneron Study Site
state: Maryland
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: Regeneron Study Site
state: Michigan
city: Royal Oak
country: United States
facility: Regeneron Study Site
state: Michigan
city: Rochester
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Chesterfield
country: United States
facility: Regeneron Study Site
state: Missouri
city: Saint Louis
country: United States
facility: Regeneron Study Site
state: Missouri
city: Saint Louis
country: United States
facility: Regeneron Study Site
state: Missouri
city: Omaha
country: United States
facility: Regeneron Study Site
state: Nebraska
city: Las Vegas
country: United States
facility: Regeneron Study Site
state: Nevada
city: Englewood
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Hackensack
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Morristown
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Neptune
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Pennington
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Summit
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Teaneck
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Albuquerque
country: United States
facility: Regeneron Study Site
state: New Mexico
city: Bronx
country: United States
facility: Regeneron Study Site
state: New York
city: Bronx
country: United States
facility: Regeneron Study Site
state: New York
city: Brooklyn
country: United States
facility: Regeneron Study Site
state: New York
city: Buffalo
country: United States
facility: Regeneron Study Site
state: New York
city: Buffalo
country: United States
facility: Regeneron Study Site 1
state: New York
city: Buffalo
country: United States
facility: Regeneron Study Site 2
state: New York
city: Jamaica
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: Rochester
country: United States
facility: Regeneron Study Site
state: New York
city: Syracuse
country: United States
facility: Regeneron Study Site
state: New York
city: West Islip
country: United States
facility: Regeneron Study Site
state: New York
city: White Plains
country: United States
facility: Regeneron Study Site
state: New York
city: Chapel Hill
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Greensboro
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Columbus
country: United States
facility: Regeneron Study Site
state: Ohio
city: Columbus
country: United States
facility: Regeneron Study Site
state: Ohio
city: Dayton
country: United States
facility: Regeneron Study Site
state: Ohio
city: Portland
country: United States
facility: Regeneron Study Site
state: Oregon
city: Portland
country: United States
facility: Regeneron Study Site
state: Oregon
city: Philadelphia
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Providence
country: United States
facility: Regeneron Study Site
state: Rhode Island
city: Providence
country: United States
facility: Regeneron Study Site
state: Rhode Island
city: Sioux Falls
country: United States
facility: Regeneron Study Site
state: South Dakota
city: Amarillo
country: United States
facility: Regeneron Study Site 1
state: Texas
city: Amarillo
country: United States
facility: Regeneron Study Site 2
state: Texas
city: Dallas
country: United States
facility: Regeneron Study Site
state: Texas
city: Dallas
country: United States
facility: Regeneron Study Site
state: Texas
city: Dallas
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: Lubbock
country: United States
facility: Regeneron Study Site
state: Texas
city: Sugar Land
country: United States
facility: Regeneron Study Site
state: Texas
city: Tyler
country: United States
facility: Regeneron Study Site
state: Texas
city: Murray
country: United States
facility: Regeneron Study Site
state: Utah
city: Salt Lake City
country: United States
facility: Regeneron Study Site
state: Utah
city: Richmond
country: United States
facility: Regeneron Study Site
state: Virginia
city: Everett
country: United States
facility: Regeneron Study Site
state: Washington
city: Seattle
country: United States
facility: Regeneron Study Site 1
state: Washington
city: Madison
country: United States
facility: Regeneron Study Site
state: Wisconsin
city: Salvador
country: Brazil
facility: Regeneron Study Site
state: Bahia
city: Fortaleza
country: Brazil
facility: Regeneron Study Site
state: Ceara
city: Curitiba
country: Brazil
facility: Regeneron Study Site
state: Paraná
city: Porto Alegre
country: Brazil
facility: Regeneron Study Site
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Regeneron Study Site
state: RS
city: Chapeco
country: Brazil
facility: Regeneron Study Site
state: Santa Catarina
city: Criciuma
country: Brazil
facility: Regeneron Study Site
state: Santa Catarina
city: Botucatu
country: Brazil
facility: Regeneron Study Site
state: Sao Paolo
city: Campinas
country: Brazil
facility: Regeneron Study Site
state: Sao Paolo
city: São Paulo
country: Brazil
facility: Regeneron Study Site
city: São Paulo
country: Brazil
facility: Regeneron Study Site
city: São Paulo
country: Brazil
facility: Regeneron Study Site
city: Las Condes
country: Chile
facility: Regeneron Study Site 1
state: Santiago De Chile
city: Las Condes
country: Chile
facility: Regeneron Study Site 2
state: Santiago De Chile
city: Vitacura
country: Chile
facility: Regeneron Study Site
state: Santiago De Chile
city: Santiago de Chile
country: Chile
facility: Regeneron Study Site
city: Guadalajara
country: Mexico
facility: Regeneron Study Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Regeneron Study Site
state: Nuevo Leon
city: Culiacán
country: Mexico
facility: Regeneron Study Site
state: Sinaloa
city: Culiacan
country: Mexico
facility: Regeneron Study Site
city: Monterrey
country: Mexico
facility: Regeneron Study Site
city: Mérida
country: Mexico
facility: Regeneron Study Site 1
city: Mérida
country: Mexico
facility: Regeneron Study Site 2
city: Veracruz
country: Mexico
facility: Regeneron Study Site
city: Zapopan
country: Mexico
facility: Regeneron Study Site
city: Chisinau
country: Moldova, Republic of
facility: Regeneron Study Site
city: Bucuresti
country: Romania
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
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.