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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452318
Recruitment Status : Completed
First Posted : June 30, 2020
Results First Posted : May 15, 2023
Last Update Posted : May 15, 2023
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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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


Condition or disease Intervention/treatment Phase
Healthy Participants Drug: REGN10933 + REGN10987 Drug: Placebo Phase 3

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 13, 2020
Actual Primary Completion Date : October 4, 2021
Actual Study Completion Date : October 4, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: REGN10933 + REGN10987 Drug: REGN10933 + REGN10987
Subcutaneous (SC) or Intramuscular (IM) injections
Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™
Placebo Comparator: Placebo Drug: Placebo
SC or IM injections


Outcome Measures
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Primary Outcome Measures :
  1. Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP [ Time Frame: Up to 1 month ]
    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.

  2. 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 [ Time Frame: Up to 14 Days ]
    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).

  3. 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 Measures :
  1. Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP [ Time Frame: Up to 1 month ]
    High viral load (> 4 log 10 copies/ml)

  2. 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 ]
  3. Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP [ Time Frame: Up to 1 month ]
    High viral load (> 4 log 10 copies/ml)

  4. 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 ]
  5. Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP [ Time Frame: Up to 1 month ]
    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)

  6. 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 ]
  7. Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP [ Time Frame: Up to 1 month ]
    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.

  8. 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 ]
  9. Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP [ Time Frame: Up to 1 month ]
    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)

  10. 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 ]
  11. 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 ]
  12. Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]
    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)

  13. 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 [ Time Frame: Up to 1 month ]
  14. 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 [ Time Frame: Up to 1 month ]
  15. 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 ]
  16. 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 ]
  17. 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 ]
  18. 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 [ Time Frame: Up to 1 month ]
    Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.

  19. 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 ]
  20. 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 ]
  21. Cohort A: 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 ]
    The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP

  22. 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 ]
  23. 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 [ Time Frame: Up to 1 month ]
    Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)

  24. Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs [ Time Frame: Up to 8 months ]
  25. Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP [ Time Frame: Up to Day 29 ]
  26. 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) ]
  27. 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 ]
  28. 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) ]
  29. 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 ]
  30. 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) ]
  31. 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 ]
  32. 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 [ Time Frame: Up to 1 month ]
    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)

  33. 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 [ Time Frame: Up to 14 Days ]
    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)

  34. 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 ]
  35. 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 ]
  36. Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples [ Time Frame: Up to day 8 visit ]
  37. Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples [ Time Frame: Up to day 15 visit ]
  38. 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 ]
  39. 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 ]
  40. 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 ]
  41. 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 ]
  42. 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 [ Time Frame: Up to 1 month ]
  43. 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 ]
  44. 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 ]
  45. 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 ]
  46. 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 ]
  47. 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 ]
  48. 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 ]
  49. 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 ]
  50. Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 [ Time Frame: Up to 8 months ]
  51. Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 [ Time Frame: Up to 8 months ]
  52. Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 [ Time Frame: Up to 8 months ]
    (TE&TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay

  53. Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 [ Time Frame: Up to 8 Months ]
    (TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Day and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452318


Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Regeneron Pharmaceuticals:
Study Protocol  [PDF] March 25, 2021
Statistical Analysis Plan  [PDF] March 26, 2021
Informed Consent Form  [PDF] January 22, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04452318    
Other Study ID Numbers: R10933-10987-COV-2069
2020-003654-71 ( EudraCT Number )
First Posted: June 30, 2020    Key Record Dates
Results First Posted: May 15, 2023
Last Update Posted: May 15, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
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).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Asymptomatic
Individuals at risk of exposure to SARS-CoV-2
Household Contacts of a Person Infected with SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Casirivimab and imdevimab drug combination
Antiviral Agents
Anti-Infective Agents