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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

Primary Purpose

Healthy Participants

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

REGN10933 + REGN10987

Placebo

About this trial

This is an interventional treatment trial for Healthy Participants focused on measuring Asymptomatic, Individuals at risk of exposure to SARS-CoV-2, Household Contacts of a Person Infected with SARS-CoV-2

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

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)
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
Participant anticipates living in the same household with the index case until study day 29
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
Willing and able to comply with study visits and study-related procedures/assessments.
Provide informed consent signed by study participant or legally acceptable representative.

Key Exclusion Criteria:

History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test at any time before the screening
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
Active respiratory or non-respiratory symptoms consistent with COVID-19
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
Nursing home resident
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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

REGN10933 + REGN10987

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP

Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.

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

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US).

Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs

Secondary Outcome Measures

Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP

High viral load (> 4 log 10 copies/ml)

Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP

Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP

High viral load (> 4 log 10 copies/ml)

Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP

Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)

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)

Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP

Symptomatic SARS-CoV-2 infection (CDC definition) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.

Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP

Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)

Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP

Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP

Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)

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

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

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

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

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

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

Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.

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

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

Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP

The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP

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

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

Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)

Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period

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

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

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)

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

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)

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

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

Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples

Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples

Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit

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

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

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

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

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

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

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

Concentrations of REGN10987 in Serum Over Time (Cohort A)

Concentrations of REGN10987 in Serum Over Time (Cohort B)

Concentrations of REGN10933 in Serum Over Time (Cohort A)

Concentrations of REGN10933 in Serum Over Time (Cohort B)

Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933

Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987

Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933

(TE&TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay

Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987

(TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay

Full Information

NCT ID

NCT04452318

First Posted

June 26, 2020

Last Updated

April 20, 2023

Sponsor

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04452318

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

July 13, 2020 (Actual)

Primary Completion Date

October 4, 2021 (Actual)

Study Completion Date

October 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Participants

Keywords

Asymptomatic, Individuals at risk of exposure to SARS-CoV-2, Household Contacts of a Person Infected with SARS-CoV-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3303 (Actual)

8. Arms, Groups, and Interventions

Arm Title

REGN10933 + REGN10987

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

REGN10933 + REGN10987

Other Intervention Name(s)

REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™

Intervention Description

Subcutaneous (SC) or Intramuscular (IM) injections

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

SC or IM injections

Primary Outcome Measure Information:

Title

Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP

Description

Time Frame

Up to 1 month

Title

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

Description

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US).

Time Frame

Up to 14 Days

Title

Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs

Time Frame

Up to 8 months

Secondary Outcome Measure Information:

Title

Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP

Description

High viral load (> 4 log 10 copies/ml)

Time Frame

Up to 1 month

Title

Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP

Time Frame

Up to 1 month

Title

Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP

Description

High viral load (> 4 log 10 copies/ml)

Time Frame

Up to 1 month

Title

Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP

Time Frame

Up to 1 month

Title

Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP

Description

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)

Time Frame

Up to 1 month

Title

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)

Time Frame

Up to 1 month

Title

Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP

Description

Time Frame

Up to 1 month

Title

Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP

Time Frame

Up to 1 month

Title

Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP

Description

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)

Time Frame

Up to 1 month

Title

Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP

Time Frame

Up to 1 month

Title

Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP

Time Frame

Week 1, Week 2, Week 3, Week 4

Title

Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP

Description

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)

Time Frame

Week 1, Week 2, Week 3, Week 4

Title

Time Frame

Up to 1 month

Title

Time Frame

Up to 1 month

Title

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

Time Frame

Up to 1 month

Title

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

Time Frame

Up to 1 month

Title

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

Time Frame

Up to 1 month

Title

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

Description

Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.

Time Frame

Up to 1 month

Title

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

Time Frame

Up to 1 month

Title

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

Time Frame

Up to 1 month

Title

Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP

Description

The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP

Time Frame

Up to 14 Days

Title

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

Time Frame

Up to Day 29

Title

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

Description

Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)

Time Frame

Up to 1 month

Title

Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs

Time Frame

Up to 8 months

Title

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP

Time Frame

Up to Day 29

Title

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period

Time Frame

Day 30 Up to Day 225 (Approximately 8 months)

Title

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP

Time Frame

Up to Day 29

Title

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period

Time Frame

Day 30 Up to Day 225 (Approximately 8 months)

Title

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP

Time Frame

Up to Day 29

Title

Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period

Time Frame

Day 30 Up to Day 225 (Approximately 8 months)

Title

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

Time Frame

Up to 14 Days

Title

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

Description

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)

Time Frame

Up to 1 month

Title

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

Description

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)

Time Frame

Up to 14 Days

Title

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

Time Frame

Up to 14 Days

Title

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

Time Frame

Up to 14 Days

Title

Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples

Time Frame

Up to day 8 visit

Title

Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples

Time Frame

Up to day 15 visit

Title

Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit

Time Frame

Day 22

Title

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

Time Frame

Up to 14 Days

Title

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

Time Frame

Up to 1 month

Title

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

Time Frame

Up to 1 month

Title

Time Frame

Up to 1 month

Title

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

Time Frame

Up to 14 Days

Title

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

Time Frame

Up to 1 month

Title

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

Time Frame

Up to 1 month

Title

Concentrations of REGN10987 in Serum Over Time (Cohort A)

Time Frame

0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose

Title

Concentrations of REGN10987 in Serum Over Time (Cohort B)

Time Frame

0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose

Title

Concentrations of REGN10933 in Serum Over Time (Cohort A)

Time Frame

0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose

Title

Concentrations of REGN10933 in Serum Over Time (Cohort B)

Time Frame

0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose

Title

Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933

Time Frame

Up to 8 months

Title

Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987

Time Frame

Up to 8 months

Title

Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933

Description

(TE&TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay

Time Frame

Up to 8 months

Title

Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987

Description

(TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay

Time Frame

Up to 8 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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) 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 Participant anticipates living in the same household with the index case until study day 29 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 Willing and able to comply with study visits and study-related procedures/assessments. Provide informed consent signed by study participant or legally acceptable representative. Key Exclusion Criteria: History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test at any time before the screening 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 Active respiratory or non-respiratory symptoms consistent with COVID-19 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 Nursing home resident 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Regeneron Study Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Regeneron Study Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Regeneron Study Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Regeneron Study Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Regeneron Study Site

City

La Palma

State/Province

California

ZIP/Postal Code

90623

Country

United States

Facility Name

Regeneron Study Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Regeneron Study Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90035

Country

United States

Facility Name

Regeneron Study Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Regeneron Study Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Regeneron Study Site

City

Montclair

State/Province

California

ZIP/Postal Code

91763

Country

United States

Facility Name

Regeneron Study Site

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Regeneron Study Site

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Regeneron Study Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Regeneron Study Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95821

Country

United States

Facility Name

Regeneron Study Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Regeneron Study Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94127

Country

United States

Facility Name

Regeneron Study Site

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Regeneron Study Site

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Regeneron Study Site

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

Regeneron Study Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Regeneron Study Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Regeneron Study Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20005

Country

United States

Facility Name

Regeneron Study Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33487

Country

United States

Facility Name

Regeneron Study Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Regeneron Study Site

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Regeneron Study Site

City

Fort Pierce

State/Province

Florida

ZIP/Postal Code

34982

Country

United States

Facility Name

Regeneron Study Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33010

Country

United States

Facility Name

Regeneron Study Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Regeneron Study Site

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33810

Country

United States

Facility Name

Regeneron Study Site

City

Loxahatchee Groves

State/Province

Florida

ZIP/Postal Code

33470

Country

United States

Facility Name

Regeneron Study Site

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Regeneron Study Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Regeneron Study Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Regeneron Study Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Regeneron Study Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Regeneron Study Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Regeneron Study Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33184

Country

United States

Facility Name

Regeneron Study Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Regeneron Study Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Regeneron Study Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Regeneron Study Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Regeneron Study Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Regeneron Study Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Regeneron Study Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

Regeneron Study Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Regeneron Study Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Regeneron Study Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Regeneron Study Site

City

Eatonton

State/Province

Georgia

ZIP/Postal Code

31024

Country

United States

Facility Name

Regeneron Study Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Regeneron Study Site

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Regeneron Study Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Regeneron Study Site 2

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Regeneron Study Site 3

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Regeneron Study Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Regeneron Study Site 1

City

Downers Grove

State/Province

Illinois

ZIP/Postal Code

60515

Country

United States

Facility Name

Regeneron Study Site 2

City

Downers Grove

State/Province

Illinois

ZIP/Postal Code

60515

Country

United States

Facility Name

Regeneron Study Site

City

Ames

State/Province

Iowa

ZIP/Postal Code

50010-3014

Country

United States

Facility Name

Regeneron Study Site

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Regeneron Study Site

City

Marrero

State/Province

Louisiana

ZIP/Postal Code

70072

Country

United States

Facility Name

Regeneron Study Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Regeneron Study Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Regeneron Study Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Regeneron Study Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Regeneron Study Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Regeneron Study Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Regeneron Study Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Regeneron Study Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Regeneron Study Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Regeneron Study Site

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

Regeneron Study Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Regeneron Study Site

City

Gulfport

State/Province

Mississippi

ZIP/Postal Code

39503

Country

United States

Facility Name

Regeneron Study Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Regeneron Study Site

City

Hazelwood

State/Province

Missouri

ZIP/Postal Code

63042

Country

United States

Facility Name

Regeneron Study Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Regeneron Study Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

Facility Name

Regeneron Study Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

Regeneron Study Site

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07960

Country

United States

Facility Name

Regeneron Study Site

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103

Country

United States

Facility Name

Regeneron Study Site

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07901

Country

United States

Facility Name

Regeneron Study Site

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666-4245

Country

United States

Facility Name

Regeneron Study Site 1

City

Bronx

State/Province

New York

ZIP/Postal Code

10451

Country

United States

Facility Name

Regeneron Study Site 2

City

Bronx

State/Province

New York

ZIP/Postal Code

10451

Country

United States

Facility Name

Regeneron Study Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Regeneron Study Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14203

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10027

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10037

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Regeneron Study Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Regeneron Study Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

Regeneron Study Site

City

Fayetteville

State/Province

North Carolina

ZIP/Postal Code

28304

Country

United States

Facility Name

Regeneron Study Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Regeneron Study Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Regeneron Study Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Regeneron Study Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267-0405

Country

United States

Facility Name

Regeneron Study Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Regeneron Study Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Regeneron Study Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45432

Country

United States

Facility Name

Regeneron Study Site

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822

Country

United States

Facility Name

Regeneron Study Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Regeneron Study Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Regeneron Study Site

City

Wilkes-Barre

State/Province

Pennsylvania

ZIP/Postal Code

18711

Country

United States

Facility Name

Regeneron Study Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Regeneron Study Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Regeneron Study Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Regeneron Study Site

City

Clinton

State/Province

South Carolina

ZIP/Postal Code

29325

Country

United States

Facility Name

Regeneron Study Site

City

Gaffney

State/Province

South Carolina

ZIP/Postal Code

29340

Country

United States

Facility Name

Regeneron Study Site

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Regeneron Study Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Regeneron Study Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Regeneron Study Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38103

Country

United States

Facility Name

Regeneron Study Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Regeneron Study Site

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Regeneron Study Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78413

Country

United States

Facility Name

Regeneron Study Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75224

Country

United States

Facility Name

Regeneron Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Facility Name

Regeneron Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Regeneron Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77026

Country

United States

Facility Name

Regeneron Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77057

Country

United States

Facility Name

Regeneron Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77093

Country

United States

Facility Name

Regeneron Study Site

City

Pearland

State/Province

Texas

ZIP/Postal Code

77584

Country

United States

Facility Name

Regeneron Study Site

City

Red Oak

State/Province

Texas

ZIP/Postal Code

75154

Country

United States

Facility Name

Regeneron Study Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78249

Country

United States

Facility Name

Regeneron Study Site

City

Tyler

State/Province

Texas

ZIP/Postal Code

75701

Country

United States

Facility Name

Regeneron Study Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Regeneron Study Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Regeneron Study Site

City

Everett

State/Province

Washington

ZIP/Postal Code

98201

Country

United States

Facility Name

Regeneron Study Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Regeneron Study Site

City

Yakima

State/Province

Washington

ZIP/Postal Code

98902

Country

United States

Facility Name

Regeneron Study Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Regeneron Study Site

City

Chisinau

ZIP/Postal Code

MD-2025

Country

Moldova, Republic of

Facility Name

Regeneron Study Site

City

Bucharest

ZIP/Postal Code

021105

Country

Romania

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.

IPD Sharing Access Criteria

Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

35803290

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. Erratum In: Lancet Infect Dis. 2022 Sep;22(9):e239.

Results Reference

derived

PubMed Identifier

35713300

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.

Results Reference

derived

PubMed Identifier

35029629

Citation

O'Brien MP, Forleo-Neto E, Sarkar N, Isa F, Hou P, Chan KC, Musser BJ, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Brown ER, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM; COVID-19 Phase 3 Prevention Trial Team. Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial. JAMA. 2022 Feb 1;327(5):432-441. doi: 10.1001/jama.2021.24939. Erratum In: JAMA. 2022 May 24;327(20):2024.

Results Reference

derived

PubMed Identifier

34473343

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.

Results Reference

derived

PubMed Identifier

34347950

Citation

O'Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Hou P, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM; Covid-19 Phase 3 Prevention Trial Team. Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. N Engl J Med. 2021 Sep 23;385(13):1184-1195. doi: 10.1056/NEJMoa2109682. Epub 2021 Aug 4.

Results Reference

derived

PubMed Identifier

34159344

Citation

O'Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Hou P, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM. Subcutaneous REGEN-COV Antibody Combination for Covid-19 Prevention. medRxiv. 2021 Jun 17:2021.06.14.21258567. doi: 10.1101/2021.06.14.21258567. Preprint.

Results Reference

derived

PubMed Identifier

34159343

Citation

O'Brien MP, Forleo-Neto E, Sarkar N, Isa F, Hou P, Chan KC, Musser BJ, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Brown ER, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM; COVID-19 Phase 3 Prevention Trial Team. Subcutaneous REGEN-COV Antibody Combination in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial. medRxiv. 2021 Sep 18:2021.06.14.21258569. doi: 10.1101/2021.06.14.21258569. Preprint.

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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

Healthy Participants

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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