Clinical trial NCT04425629: Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric 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 Ambulatory Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Keywords: Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
coronavirus
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 10078
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1/Phase 2/Phase 3
Primary purpose: TREATMENT

Brief summary: Phase 1

* To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
* To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2

Phase 2

• To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2

Phase 3

* Cohort 1 (≥18 Years Old, Not Pregnant at Randomization)

  • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death
* Cohort 2 (\<18 Years Old, Not Pregnant at Randomization)

  * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
  * To further characterize the concentrations of REGN10933 and REGN10987 in serum over time
* Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of REGN10933+REGN10987


Eligibility criteria: Key Inclusion Criteria:

* Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, and an appropriate sample such as nasopharyngeal \[NP\], nasal, oropharyngeal \[OP\], or saliva)
* Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization
* Maintains O2 saturation ≥93% on room air
* Is able to understand and complete study-related questionnaires (patients aged ≥12 years only)

Key Exclusion Criteria:

* Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
* Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
* Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
* Prior use (prior to randomization), current use (at randomization) or planned use (within 90 days of study drug administration or per current CDC recommendations, as applicable) of any authorized or approved vaccine for COVID-19
* Has participated, is participating or plans to participate in a clinical research study evaluation any authorized, approved or investigational vaccine for COVID-19

NOTE: Other Protocol defined Inclusion/Exclusion criteria apply

Primary outcomes:
measure: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3]
timeFrame: Through Day 29
measure: Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
timeFrame: Through Day 4
measure: Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
timeFrame: Through Day 29
measure: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2)
timeFrame: Baseline up to Day 7
measure: Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
timeFrame: Through Day 29
measure: Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo)
timeFrame: Through Day 29
measure: Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2)
timeFrame: Up to Nominal Sampling Day 28
Secondary outcomes:
measure: Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo)
timeFrame: Up to Day 29
measure: Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo)
timeFrame: Through Day 29
measure: Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo)
timeFrame: Day 4 thru Day 29
measure: Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 2.4g vs. Placebo)
timeFrame: From Day 4 Through Day 29
measure: Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort)
timeFrame: Day 5, Day 7, Day 15, Day 29
measure: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2)
timeFrame: Day 1 to Day 29
measure: Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit Through Day 29 (Ph1, Ph2)
timeFrame: Through Day 29
measure: Percentage of Participants With ≥1 COVID-19 Related Hospitalization, Emergency Room, or Urgent Care Visit Through Day 29 (Ph1, Ph2)
timeFrame: Through Day 29
measure: Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
timeFrame: Up to Day 29
measure: Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV
timeFrame: Through Day 29
measure: Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV
timeFrame: Through day 29
measure: Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3)
timeFrame: Up to Nominal Sampling Day 28
measure: Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1)
timeFrame: Through Day 29
measure: Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1)
timeFrame: Through Day 29
measure: Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1)
timeFrame: Through Day 29
measure: Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
timeFrame: Through Day 29
measure: Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph3 Cohort 2 - Cohort 3)
timeFrame: Through Day 29
measure: Immunogenicity as Measured by ADA to REGN10987 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
timeFrame: Through Day 29
measure: Immunogenicity as Measured by ADA to REGN10987 (Ph3 Cohort 2 and Cohort 3)
timeFrame: Through Day 29
measure: Immunogenicity as Measured by Neutralizing Antibodies (NAbs) to REGN10933 (Ph3 Cohort 2, Ph3 Cohort 3)
timeFrame: Through Day 29
measure: Immunogenicity as Measured by NAbs to REGN10987 (Ph3 Cohort 2 - Cohort 3)
timeFrame: Through Day 29
measure: Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2)
timeFrame: Through Day 29
measure: Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2)
timeFrame: Through Day 29
measure: Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV
timeFrame: Through Day 29
measure: Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV
timeFrame: Through Day 29
measure: Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2)
timeFrame: Through Day 29
measure: Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only)
timeFrame: Through Day 29
measure: Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only)
timeFrame: Though Day 29
measure: Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only)
timeFrame: Through Day 29
measure: Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only)
timeFrame: Through Day 29
measure: Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
timeFrame: Day 4 Through Day 29
measure: Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
timeFrame: Day 4 Through Day 29
measure: Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
timeFrame: Through Day 29
measure: Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
timeFrame: Through Day 29
measure: Number of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Phase 3 Cohort 2)
timeFrame: Through Day 29
measure: Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
timeFrame: Through Day 29
measure: Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
timeFrame: Through Day 29
measure: Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2)
timeFrame: Through Day 29
measure: Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
timeFrame: Through Day 29
measure: Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
timeFrame: Through Day 29
measure: Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
timeFrame: Through Day 29
measure: Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
timeFrame: Through Day 29
measure: Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
timeFrame: Through Day 29
measure: Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
timeFrame: Through Day 29
measure: Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
timeFrame: Through Day 29
measure: Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
timeFrame: Through Day 29
measure: Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g
timeFrame: by Day 29, Day 120, and Day 169
measure: Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g
timeFrame: by Day 29, Day 120, and Day 169
measure: Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only)
timeFrame: Through Day 29
measure: Correlation of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only)
timeFrame: Up to Day 29
measure: Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasal Swabs - (Phase 1 Only)
timeFrame: Baseline Up To Day 29
measure: Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Saliva Samples - (Phase 1 Only)
timeFrame: Baseline Up to Day 29
measure: Concordance of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only)
timeFrame: Up To Day 29
measure: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by RT-qPCR in Saliva Samples - (Phase 1)
timeFrame: Baseline up to Day 22
measure: Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only)
timeFrame: Through Day 29
measure: Duration of Symptoms Consistent With COVID-19 (Phase 2 Only)
timeFrame: Through Day 29
measure: Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
timeFrame: Through Day 29
measure: Number of Participants Admitted to a Hospital Due to COVID-19 (Phase 1, Phase 2)
timeFrame: Through Day 29
measure: Time to Negative RT-qPCR in All Tested Samples With no Subsequent Positive RT-qPCR in Any Tested Samples - (Phase 1 Only)
timeFrame: Through Day 29
measure: Proportion of Participants With All-cause Mortality (Phase 2 Asymptomatic)
timeFrame: Through Day 29
measure: Time to All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
timeFrame: Through Day 169
measure: Time to All-cause Death (Ph3 Cohort 1- 2.4g vs Placebo)
timeFrame: Through Day 169
measure: Time to All-cause Death (Phase 3 Cohort 2)
timeFrame: Through Day 29
measure: Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 1.2g vs Placebo)
timeFrame: Through Day 29
measure: Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 2.4g vs Placebo)
timeFrame: Through Day 29
measure: Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Phase 3 Cohort 2)
timeFrame: Through Day 29
measure: Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo)
timeFrame: Baseline up to Day 29
measure: Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo)
timeFrame: Baseline up to Day 29
measure: Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2)
timeFrame: Baseline up to Day 29
measure: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 1)
timeFrame: Baseline to Day 7
measure: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 2)
timeFrame: Baseline to Day 7
measure: Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only)
timeFrame: Day 0, Day 5, Day 7, Day 15, Day 29
measure: Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only)
timeFrame: Day 0, Day 5, Day 7, Day 15, Day 29
measure: Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 1.2g IV
timeFrame: Through Day 29
measure: Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 2.4g IV
timeFrame: Through Day 29
measure: Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 2)
timeFrame: Through Day 29
measure: Number of Days of Hospitalization Due to COVID-19 (Phase 2 Asymptomatic)
timeFrame: Up to Day 29
measure: Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 1.2g IV
timeFrame: Through Day 29
measure: Percentage of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 2.4g IV
timeFrame: Through Day 29
measure: Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 2)
timeFrame: Through Day 29
measure: Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Next Phase 2) #87
timeFrame: Through Day 29
measure: Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 1.2g
timeFrame: Through Day 29
measure: Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 2.4g
timeFrame: Through Day 29
measure: Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 2)
timeFrame: Through Day 29
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Regeneron Study Site
state: Arizona
city: Tucson
country: United States
facility: Regeneron Study Site
state: Arizona
city: Tucson
country: United States
facility: Regeneron Study Site
state: Arizona
city: Canoga Park
country: United States
facility: Regeneron Study Site
state: California
city: La Mesa
country: United States
facility: Regeneron Study Site
state: California
city: La Palma
country: United States
facility: Regeneron Study Site
state: California
city: Long Beach
country: United States
facility: Regeneron Study Site 1
state: California
city: Long Beach
country: United States
facility: Regeneron Study Site 2
state: California
city: Long Beach
country: United States
facility: Regeneron Study Site 3
state: California
city: Los Angeles
country: United States
facility: Regeneron Study Site
state: California
city: Montclair
country: United States
facility: Regeneron Study Site
state: California
city: Rolling Hills Estates
country: United States
facility: Regeneron Study Site
state: California
city: Sacramento
country: United States
facility: Regeneron Study Site
state: California
city: San Francisco
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: Colorado Springs
country: United States
facility: Regeneron Study Site
state: Colorado
city: Washington
country: United States
facility: Regeneron Study Site
state: District of Columbia
city: Boca Raton
country: United States
facility: Regeneron Study Site
state: Florida
city: DeLand
country: United States
facility: Regeneron Study Site
state: Florida
city: Fort Pierce
country: United States
facility: Regeneron Study Site
state: Florida
city: Hialeah
country: United States
facility: Regeneron Study Site
state: Florida
city: Loxahatchee Groves
country: United States
facility: Regeneron Study Site
state: Florida
city: Maitland
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site 1
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site 2
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Saint Petersburg
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: West Palm Beach
country: United States
facility: Regeneron Study Site
state: Florida
city: Winter Haven
country: United States
facility: Regeneron Study Site
state: Florida
city: Winter Park
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: Columbus
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: Downers Grove
country: United States
facility: Regeneron Study Site 1
state: Illinois
city: Downers Grove
country: United States
facility: Regeneron Study Site 2
state: Illinois
city: Downers Grove
country: United States
facility: Regeneron Study Site
state: Illinois
city: Ames
country: United States
facility: Regeneron Study Site
state: Iowa
city: Iowa City
country: United States
facility: Regeneron Study Site
state: Iowa
city: Lake Charles
country: United States
facility: Regeneron Study Site
state: Louisiana
city: Marrero
country: United States
facility: Regeneron Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Regeneron Study Site
state: Louisiana
city: Shreveport
country: United States
facility: Regeneron Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Regeneron Study Site
state: Maryland
city: Royal Oak
country: United States
facility: Regeneron Study Site
state: Michigan
city: Jackson
country: United States
facility: Regeneron Study Site
state: Mississippi
city: Las Vegas
country: United States
facility: Regeneron Study Site
state: Nevada
city: Ridgewood
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Teaneck
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Santa Fe
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: 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: Charlotte
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Durham
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Wilmington
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Columbus
country: United States
facility: Regeneron Study Site
state: Ohio
city: Dayton
country: United States
facility: Regeneron Study Site
state: Ohio
city: Dayton
country: United States
facility: Regeneron Study Site
state: Ohio
city: Philadelphia
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Providence
country: United States
facility: Regeneron Study Site
state: Rhode Island
city: Charleston
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Clinton
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Regeneron Study Site
state: South Dakota
city: Memphis
country: United States
facility: Regeneron Study Site 2
state: Tennessee
city: Memphis
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Amarillo
country: United States
facility: Regeneron Study Site
state: Texas
city: Corpus Christi
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: 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: Pearland
country: United States
facility: Regeneron Study Site
state: Texas
city: Red Oak
country: United States
facility: Regeneron Study Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site
state: Texas
city: Tyler
country: United States
facility: Regeneron Study Site
state: Texas
city: Falls Church
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
state: Washington
city: Seattle
country: United States
facility: Regeneron Study Site
state: Washington
city: Madison
country: United States
facility: Regeneron Study Site
state: Wisconsin
city: Guadalajara
country: Mexico
facility: Regeneron Study Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Regeneron Study Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Regeneron Study Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Regeneron Study Site
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Regeneron Study Site
state: Nuevo León
city: Merida
country: Mexico
facility: Regeneron Study Site
state: Yucatan
city: Chihuahua
country: Mexico
facility: Regeneron Study Site
city: Ciudad de Mexico
country: Mexico
facility: Regeneron Study Site
city: Durango
country: Mexico
facility: Regeneron Study Site
city: Mérida
country: Mexico
facility: Regeneron Study Site
city: Veracruz
country: Mexico
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: Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Xiao J, Hooper AT, Hamilton JD, Musser BJ, Rofail D, Hussein M, Im J, Atmodjo DY, Perry C, Pan C, Mahmood A, Hosain R, Davis JD, Turner KC, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Roque-Guerrero L, Acloque G, Aazami H, Cannon K, Simon-Campos JA, Bocchini JA, Kowal B, DiCioccio AT, Soo Y, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. N Engl J Med. 2021 Dec 2;385(23):e81. doi: 10.1056/NEJMoa2108163. Epub 2021 Sep 29.
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: Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Musser BJ, Soo Y, Rofail D, Im J, Perry C, Pan C, Hosain R, Mahmood A, Davis JD, Turner KC, Hooper AT, Hamilton JD, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Kohli A, Sachdeva Y, Graber X, Kowal B, DiCioccio T, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):238-251. doi: 10.1056/NEJMoa2035002. Epub 2020 Dec 17.