Clinical trial NCT04452318: COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Participants
Keywords: Asymptomatic
Individuals at risk of exposure to SARS-CoV-2
Household Contacts of a Person Infected with SARS-CoV-2
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-06-30
Enrollment: 3303
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objectives:

Cohort A:

• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR

Cohort A and Cohort A1:

• To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo

Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term)

Cohort B and Cohort B1

• To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration compared to placebo

Detailed description: Cohort A: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR negative at baseline

Cohort A1: pediatric subjects (\<12 years) who are SARS-CoV-2 RT--qPCR negative at baseline

Cohort B: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR positive at baseline

Cohort B1: pediatric subjects (\<12 years) who are SARS-CoV-2 RT--qPCR positive at baseline

Eligibility criteria: Key Inclusion Criteria:

1. Adult subjects 18 years of age (irrespective of weight) and above at the signing of informed consent or adolescent participants ≥12 to \<18 years of age, or pediatric participants \<12 years of age at the signing of the assent (parent/guardian sign the informed consent)
2. Asymptomatic household contact with exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). To be included in the study, participants must be randomized within 96 hours of collection of the index cases' positive SARS-COV-2 diagnostic test sample
3. Participant anticipates living in the same household with the index case until study day 29
4. Is judged by the investigator to be in good health based on medical history and physical examination at screening/baseline, including participants who are healthy or have a chronic, stable medical condition
5. Willing and able to comply with study visits and study-related procedures/assessments.
6. Provide informed consent signed by study participant or legally acceptable representative.

Key Exclusion Criteria:

1. History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test at any time before the screening
2. Participant has lived with individuals who have had previous SARS-CoV-2 infection or currently lives with individuals who have SARS-CoV-2 infection, with the exception of the index case(s), the first individual(s) known to be infected in the household
3. Active respiratory or non-respiratory symptoms consistent with COVID-19
4. History of respiratory illness with sign/symptoms of SARS-CoV-2 infection, in the opinion of the investigator, within the prior 6 months to screening
5. Nursing home resident
6. Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Primary outcomes:
measure: Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP
timeFrame: Up to 1 month
measure: Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
timeFrame: Up to 14 Days
measure: Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs
timeFrame: Up to 8 months
Secondary outcomes:
measure: Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP
timeFrame: Up to 1 month
measure: Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)
timeFrame: Up to 1 month
measure: Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Among Individuals With ≥1 RT-qPCR Positive That Has an Onset During the EAP
timeFrame: Up to 1 month
measure: Cohort A: SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Corresponding to the Onset of First Positive RT-qPCR During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Area Under the Curve (AUC) in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP Until the First Confirmed Negative Test
timeFrame: Up to 1 month
measure: Cohort A: Total Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Percentage of Participants With at Least 1 COVID-19-related Hospitalization or Emergency Room Visit Associated With a Positive RT-qPCR During the EAP or All-cause Death
timeFrame: Up to 1 month
measure: Cohort A: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
timeFrame: Up to 14 Days
measure: Cohort A: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
timeFrame: Up to Day 29
measure: Cohort A: Number of Days Missed for Daily Responsibilities Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
timeFrame: Up to 1 month
measure: Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs
timeFrame: Up to 8 months
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
timeFrame: Up to Day 29
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
timeFrame: Day 30 Up to Day 225 (Approximately 8 months)
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP
timeFrame: Up to Day 29
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period
timeFrame: Day 30 Up to Day 225 (Approximately 8 months)
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP
timeFrame: Up to Day 29
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period
timeFrame: Day 30 Up to Day 225 (Approximately 8 months)
measure: Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Broad-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
timeFrame: Up to 14 Days
measure: Cohort B: Percentage of Participants With Asymptomatic Infection Who Develop Signs and Symptoms (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
timeFrame: Up to 1 month
measure: Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Strict-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
timeFrame: Up to 14 Days
measure: Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
timeFrame: Up to 14 Days
measure: Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Strict-term Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
timeFrame: Up to 14 Days
measure: Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples
timeFrame: Up to day 8 visit
measure: Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples
timeFrame: Up to day 15 visit
measure: Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit
timeFrame: Day 22
measure: Cohort B: AUC in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP to the First Confirmed Negative Test
timeFrame: Up to 14 Days
measure: Cohort B: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples in Participants With 1 or More Positive Test That Has an Onset During the EAP
timeFrame: Up to 1 month
measure: Cohort B: Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
timeFrame: Up to 1 month
measure: Cohort B: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset at Baseline or During the EAP
timeFrame: Up to 1 month
measure: Cohort B: Percentage of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
timeFrame: Up to 14 Days
measure: Cohort B: Number of Days Missed for Daily Responsibilities (Where Applicable) Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
timeFrame: Up to 1 month
measure: Cohort B: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
timeFrame: Up to 1 month
measure: Concentrations of REGN10987 in Serum Over Time (Cohort A)
timeFrame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
measure: Concentrations of REGN10987 in Serum Over Time (Cohort B)
timeFrame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
measure: Concentrations of REGN10933 in Serum Over Time (Cohort A)
timeFrame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
measure: Concentrations of REGN10933 in Serum Over Time (Cohort B)
timeFrame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
measure: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
timeFrame: Up to 8 months
measure: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
timeFrame: Up to 8 months
measure: Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933
timeFrame: Up to 8 months
measure: Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987
timeFrame: Up to 8 Months
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: 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
state: California
city: Los Angeles
country: United States
facility: Regeneron Study Site
state: California
city: Los Angeles
country: United States
facility: Regeneron Study Site
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: Northridge
country: United States
facility: Regeneron Study Site
state: California
city: Oxnard
country: United States
facility: Regeneron Study Site
state: California
city: Sacramento
country: United States
facility: Regeneron Study Site
state: California
city: Sacramento
country: United States
facility: Regeneron Study Site
state: California
city: San Diego
country: United States
facility: Regeneron Study Site
state: California
city: San Francisco
country: United States
facility: Regeneron Study Site
state: California
city: Stanford
country: United States
facility: Regeneron Study Site
state: California
city: Torrance
country: United States
facility: Regeneron Study Site
state: California
city: Torrance
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: Clearwater
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: Jacksonville
country: United States
facility: Regeneron Study Site
state: Florida
city: Lakeland
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
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: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Orlando
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 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: Columbus
country: United States
facility: Regeneron Study Site
state: Georgia
city: Decatur
country: United States
facility: Regeneron Study Site
state: Georgia
city: Eatonton
country: United States
facility: Regeneron Study Site
state: Georgia
city: Marietta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Sandy Springs
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 2
state: Illinois
city: Chicago
country: United States
facility: Regeneron Study Site 3
state: Illinois
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: Ames
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: Metairie
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: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Detroit
country: United States
facility: Regeneron Study Site
state: Michigan
city: Royal Oak
country: United States
facility: Regeneron Study Site
state: Michigan
city: Minneapolis
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Gulfport
country: United States
facility: Regeneron Study Site
state: Mississippi
city: Jackson
country: United States
facility: Regeneron Study Site
state: Mississippi
city: Hazelwood
country: United States
facility: Regeneron Study Site
state: Missouri
city: Saint Louis
country: United States
facility: Regeneron Study Site
state: Missouri
city: Las Vegas
country: United States
facility: Regeneron Study Site
state: Nevada
city: Las Vegas
country: United States
facility: Regeneron Study Site
state: Nevada
city: Morristown
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Newark
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: Bronx
country: United States
facility: Regeneron Study Site 1
state: New York
city: Bronx
country: United States
facility: Regeneron Study Site 2
state: New York
city: Bronx
country: United States
facility: Regeneron Study Site
state: New York
city: Buffalo
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: Chapel Hill
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Charlotte
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Fayetteville
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Raleigh
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Wilmington
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Regeneron Study Site
state: Ohio
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: Danville
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Wilkes-Barre
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: Charleston
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Clinton
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Gaffney
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Regeneron Study Site
state: South Dakota
city: Chattanooga
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Knoxville
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Memphis
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Nashville
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Bellaire
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: 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: Tyler
country: United States
facility: Regeneron Study Site
state: Texas
city: Charlottesville
country: United States
facility: Regeneron Study Site
state: Virginia
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
state: Washington
city: Yakima
country: United States
facility: Regeneron Study Site
state: Washington
city: Madison
country: United States
facility: Regeneron Study Site
state: Wisconsin
city: Chisinau
country: Moldova, Republic of
facility: Regeneron Study Site
city: Bucharest
country: Romania
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Herman GA, O'Brien MP, Forleo-Neto E, Sarkar N, Isa F, Hou P, Chan KC, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Musser BJ, Davis JD, Turner KC, Mahmood A, Hooper AT, Hamilton JD, Parrino J, Subramaniam D, Baum A, Kyratsous CA, DiCioccio AT, Stahl N, Braunstein N, Yancopoulos GD, Weinreich DM; COVID-19 Phase 3 Prevention Trial Team. Efficacy and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2022 Oct;22(10):1444-1454. doi: 10.1016/S1473-3099(22)00416-9. Epub 2022 Jul 5.
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