Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19

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: NCT04425629

Recruitment Status : Terminated (Emerging SARS-CoV-2 variants impacting susceptibility to study drug)

First Posted : June 11, 2020

Results First Posted : December 21, 2023

Last Update Posted : December 21, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Regeneron Pharmaceuticals

Study Description

Brief Summary:

Phase 1

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

Phase 2

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

Phase 3

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

• To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death
Cohort 2 (<18 Years Old, Not Pregnant at Randomization)
- To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
- To further characterize the concentrations of REGN10933 and REGN10987 in serum over time
Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of REGN10933+REGN10987

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: casirivimab+imdevimab combination therapy	Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10078 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Intervention Model Description:	Phase 1/Phase 2/Phase 3
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19
Actual Study Start Date :	June 16, 2020
Actual Primary Completion Date :	January 21, 2022
Actual Study Completion Date :	June 9, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

Drug Information available for: Imdevimab Casirivimab

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease Severe Acute Respiratory Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: casirivimab+imdevimab low dose Low dose or body-weight equivalent for those under 18 years of age.	Drug: casirivimab+imdevimab combination therapy Administered intravenously (IV) single dose Other Names: REGN-COV2 REGN10933 REGN10987 REGEN-COV™ Ronapreve™

Outcome Measures

Primary Outcome Measures :

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] [ Time Frame: Through Day 29 ]
Primary:

Phase 1, Phase 3 (Cohort 2 and Cohort 3)

Secondary:

Phase 2, Phase 3 (Cohort 1)
Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3) [ Time Frame: Through Day 4 ]
Primary:

Phase 1, Phase 3 (Cohort 2 and Cohort 3)

Secondary:

Phase 2, Phase 3 (Cohort 1)
Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3) [ Time Frame: Through Day 29 ]
Primary:

Phase 1, Phase 3 (Cohort 2 and Cohort 3)

Secondary:

Phase 2, Phase 3 (Cohort 1)
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2) [ Time Frame: Baseline up to Day 7 ]
Primary:

Phase 1, Phase 2
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo) [ Time Frame: Through Day 29 ]
Primary:

Phase 3 (Cohort 1)
Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2) [ Time Frame: Up to Nominal Sampling Day 28 ]
Phase 3 Cohort 2

[Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]

Secondary Outcome Measures :

Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo) [ Time Frame: Up to Day 29 ]
Phase 3 Cohort 1
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 1)
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo) [ Time Frame: Day 4 thru Day 29 ]
Phase 3 (Cohort 1)
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 2.4g vs. Placebo) [ Time Frame: From Day 4 Through Day 29 ]
Phase 3 (Cohort 1)
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort) [ Time Frame: Day 5, Day 7, Day 15, Day 29 ]
Next Phase 2 Symptomatic
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2) [ Time Frame: Day 1 to Day 29 ]
Phase 1, Phase 2
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit Through Day 29 (Ph1, Ph2) [ Time Frame: Through Day 29 ]
Phase 1, Phase 2
Percentage of Participants With ≥1 COVID-19 Related Hospitalization, Emergency Room, or Urgent Care Visit Through Day 29 (Ph1, Ph2) [ Time Frame: Through Day 29 ]
Phase 1, Phase 2
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only) [ Time Frame: Up to Day 29 ]
Phase 2 Only
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1 - Placebo vs. 1.2 g IV
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV [ Time Frame: Through day 29 ]
Phase 3 (Cohort 1)
Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3) [ Time Frame: Up to Nominal Sampling Day 28 ]
Secondary:

Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 3) - Symptomatic Participants

[Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1) [ Time Frame: Through Day 29 ]
Phase 1 Only
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1) [ Time Frame: Through Day 29 ]
Phase 1 Only
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1) [ Time Frame: Through Day 29 ]
Phase 1 Only
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1) [ Time Frame: Through Day 29 ]
Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph3 Cohort 2 - Cohort 3) [ Time Frame: Through Day 29 ]
Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants
Immunogenicity as Measured by ADA to REGN10987 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1) [ Time Frame: Through Day 29 ]
Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants
Immunogenicity as Measured by ADA to REGN10987 (Ph3 Cohort 2 and Cohort 3) [ Time Frame: Through Day 29 ]
Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants
Immunogenicity as Measured by Neutralizing Antibodies (NAbs) to REGN10933 (Ph3 Cohort 2, Ph3 Cohort 3) [ Time Frame: Through Day 29 ]
Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants

(TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Immunogenicity as Measured by NAbs to REGN10987 (Ph3 Cohort 2 - Cohort 3) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants

(TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2) [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 2)
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2) [ Time Frame: Through Day 29 ]
Phase 1, Phase 2 Medically-attended Visits include Hospitalizations, ER visits, Urgent Care Clinic visits, Outpatient/physician office/telemedicine visits
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 1)
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2) [ Time Frame: Through Day 29 ]
Phase 1 and Phase 2
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only) [ Time Frame: Through Day 29 ]
Phase 1 Only
Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only) [ Time Frame: Though Day 29 ]
Phase 1 Only
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only) [ Time Frame: Through Day 29 ]
Phase 1 Only
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only) [ Time Frame: Through Day 29 ]
Phase 1 Only - Tlast (Time of last quantifiable concentration)
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) [ Time Frame: Day 4 Through Day 29 ]
Phase 3 Cohort 1
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) [ Time Frame: Day 4 Through Day 29 ]
Phase 3 Cohort 1
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Number of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Phase 3 Cohort 2) [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 2)
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2) [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 2)
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g [ Time Frame: by Day 29, Day 120, and Day 169 ]
Phase 3 Cohort 1
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g [ Time Frame: by Day 29, Day 120, and Day 169 ]
Phase 3 Cohort 1 Placebo vs. 2.4g IV
Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only) [ Time Frame: Through Day 29 ]
Next Phase 2 Only
Correlation of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only) [ Time Frame: Up to Day 29 ]
Phase 1 Only
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasal Swabs - (Phase 1 Only) [ Time Frame: Baseline Up To Day 29 ]
Phase 1 Only
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Saliva Samples - (Phase 1 Only) [ Time Frame: Baseline Up to Day 29 ]
Phase 1 Only
Concordance of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only) [ Time Frame: Up To Day 29 ]
Phase 1 Only
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by RT-qPCR in Saliva Samples - (Phase 1) [ Time Frame: Baseline up to Day 22 ]
Phase 1 Only
Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only) [ Time Frame: Through Day 29 ]
Phase 2 Only
Duration of Symptoms Consistent With COVID-19 (Phase 2 Only) [ Time Frame: Through Day 29 ]
Phase 2 Only
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only) [ Time Frame: Through Day 29 ]
Phase 2 Only
Number of Participants Admitted to a Hospital Due to COVID-19 (Phase 1, Phase 2) [ Time Frame: Through Day 29 ]
Phase 1, Phase 2
Time to Negative RT-qPCR in All Tested Samples With no Subsequent Positive RT-qPCR in Any Tested Samples - (Phase 1 Only) [ Time Frame: Through Day 29 ]
Phase 1 Only
Proportion of Participants With All-cause Mortality (Phase 2 Asymptomatic) [ Time Frame: Through Day 29 ]
Phase 2 Asymptomatic
Time to All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo) [ Time Frame: Through Day 169 ]
Phase 3 Cohort 1 (1.2g IV)
Time to All-cause Death (Ph3 Cohort 1- 2.4g vs Placebo) [ Time Frame: Through Day 169 ]
Phase 3 Cohort 1 (2.4g IV)
Time to All-cause Death (Phase 3 Cohort 2) [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 2)
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 1.2g vs Placebo) [ Time Frame: Through Day 29 ]
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 2.4g vs Placebo) [ Time Frame: Through Day 29 ]
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Phase 3 Cohort 2) [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 2)
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo) [ Time Frame: Baseline up to Day 29 ]
Phase 3 Cohort 1
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo) [ Time Frame: Baseline up to Day 29 ]
Phase 3 Cohort 1
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2) [ Time Frame: Baseline up to Day 29 ]
Phase 3 Cohort 2
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 1) [ Time Frame: Baseline to Day 7 ]
Phase 3 (Cohort 1)
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 2) [ Time Frame: Baseline to Day 7 ]
Phase 3 (Cohort 2)
Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only) [ Time Frame: Day 0, Day 5, Day 7, Day 15, Day 29 ]
Next Phase 2 Symptomatic
Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only) [ Time Frame: Day 0, Day 5, Day 7, Day 15, Day 29 ]
Next Phase 2 Symptomatic
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 1.2g IV [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 1)
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 2.4g IV [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 1)
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 2) [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 2)
Number of Days of Hospitalization Due to COVID-19 (Phase 2 Asymptomatic) [ Time Frame: Up to Day 29 ]
Phase 2 Only
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 1.2g IV [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 1)
Percentage of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 2.4g IV [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 1)
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 2) [ Time Frame: Through Day 29 ]
Phase 3 (Cohort 2)
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Next Phase 2) #87 [ Time Frame: Through Day 29 ]
Next Phase 2
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 1.2g [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 2.4g [ Time Frame: Through Day 29 ]
Phase 3 Cohort 1
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 2) [ Time Frame: Through Day 29 ]
Phase 3 Cohort 2

Eligibility Criteria

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:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

NOTE: Other Protocol defined Inclusion/Exclusion criteria apply

Contacts and Locations

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): NCT04425629

Locations

Show 114 study locations

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United States, Arizona
Regeneron Study Site
Mesa, Arizona, United States, 85210
Regeneron Study Site
Tucson, Arizona, United States, 85712
Regeneron Study Site
Tucson, Arizona, United States, 85724
United States, California
Regeneron Study Site
Canoga Park, California, United States, 91303
Regeneron Study Site
La Mesa, California, United States, 91942
Regeneron Study Site
La Palma, California, United States, 90623
Regeneron Study Site 1
Long Beach, California, United States, 90806
Regeneron Study Site 2
Long Beach, California, United States, 90806
Regeneron Study Site 3
Long Beach, California, United States, 90806
Regeneron Study Site
Los Angeles, California, United States, 90036
Regeneron Study Site
Montclair, California, United States, 91763
Regeneron Study Site
Rolling Hills Estates, California, United States, 90274
Regeneron Study Site
Sacramento, California, United States, 95817
Regeneron Study Site
San Francisco, California, United States, 94127
Regeneron Study Site
Santa Monica, California, United States, 90404
Regeneron Study Site
Stanford, California, United States, 94305
United States, Colorado
Regeneron Study Site
Aurora, Colorado, United States, 80045
Regeneron Study Site
Colorado Springs, Colorado, United States, 80907
United States, District of Columbia
Regeneron Study Site
Washington, District of Columbia, United States, 20037
United States, Florida
Regeneron Study Site
Boca Raton, Florida, United States, 33487
Regeneron Study Site
DeLand, Florida, United States, 32720
Regeneron Study Site
Fort Pierce, Florida, United States, 34982
Regeneron Study Site
Hialeah, Florida, United States, 33010
Regeneron Study Site
Loxahatchee Groves, Florida, United States, 33470
Regeneron Study Site
Maitland, Florida, United States, 32751
Regeneron Study Site
Miami, Florida, United States, 33012
Regeneron Study Site 1
Miami, Florida, United States, 33126
Regeneron Study Site 2
Miami, Florida, United States, 33126
Regeneron Study Site
Miami, Florida, United States, 33130
Regeneron Study Site
Miami, Florida, United States, 33144
Regeneron Study Site
Miami, Florida, United States, 33184
Regeneron Study Site
Saint Petersburg, Florida, United States, 33705
Regeneron Study Site
Sarasota, Florida, United States, 34239
Regeneron Study Site
Tampa, Florida, United States, 33606
Regeneron Study Site
West Palm Beach, Florida, United States, 33407
Regeneron Study Site
Winter Haven, Florida, United States, 33880
Regeneron Study Site
Winter Park, Florida, United States, 32789
United States, Georgia
Regeneron Study Site
Atlanta, Georgia, United States, 30309
Regeneron Study Site
Atlanta, Georgia, United States, 30322
Regeneron Study Site
Augusta, Georgia, United States, 30912
Regeneron Study Site
Columbus, Georgia, United States, 31904
Regeneron Study Site
Marietta, Georgia, United States, 30060
United States, Illinois
Regeneron Study Site
Chicago, Illinois, United States, 60607
Regeneron Study Site 1
Downers Grove, Illinois, United States, 60515
Regeneron Study Site 2
Downers Grove, Illinois, United States, 60515
Regeneron Study Site
Downers Grove, Illinois, United States, 60515
United States, Iowa
Regeneron Study Site
Ames, Iowa, United States, 50010-3014
Regeneron Study Site
Iowa City, Iowa, United States, 52242
United States, Louisiana
Regeneron Study Site
Lake Charles, Louisiana, United States, 70601
Regeneron Study Site
Marrero, Louisiana, United States, 70072
Regeneron Study Site
New Orleans, Louisiana, United States, 70114
Regeneron Study Site
Shreveport, Louisiana, United States, 71118
United States, Maryland
Regeneron Study Site
Baltimore, Maryland, United States, 21201
United States, Michigan
Regeneron Study Site
Royal Oak, Michigan, United States, 48073
United States, Mississippi
Regeneron Study Site
Jackson, Mississippi, United States, 39216
United States, Nevada
Regeneron Study Site
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Regeneron Study Site
Ridgewood, New Jersey, United States, 07450
Regeneron Study Site
Teaneck, New Jersey, United States, 07666
United States, New Mexico
Regeneron Study Site
Santa Fe, New Mexico, United States, 87505
United States, New York
Regeneron Study Site
Bronx, New York, United States, 10451
Regeneron Study Site
Bronx, New York, United States, 10461
Regeneron Study Site
Jamaica, New York, United States, 11432
Regeneron Study Site
New York, New York, United States, 10003
Regeneron Study Site
New York, New York, United States, 10019
Regeneron Study Site
New York, New York, United States, 10025
Regeneron Study Site
New York, New York, United States, 10029
Regeneron Study Site
New York, New York, United States, 10032
Regeneron Study Site
New York, New York, United States, 10037
United States, North Carolina
Regeneron Study Site
Charlotte, North Carolina, United States, 28209
Regeneron Study Site
Durham, North Carolina, United States, 27710
Regeneron Study Site
Wilmington, North Carolina, United States, 28401
United States, Ohio
Regeneron Study Site
Columbus, Ohio, United States, 43215
Regeneron Study Site
Dayton, Ohio, United States, 45409
Regeneron Study Site
Dayton, Ohio, United States, 45432
United States, Pennsylvania
Regeneron Study Site
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
Regeneron Study Site
Providence, Rhode Island, United States, 02903
United States, South Carolina
Regeneron Study Site
Charleston, South Carolina, United States, 29425
Regeneron Study Site
Clinton, South Carolina, United States, 29325
United States, South Dakota
Regeneron Study Site
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Regeneron Study Site 2
Memphis, Tennessee, United States, 38103
Regeneron Study Site
Memphis, Tennessee, United States, 38103
United States, Texas
Regeneron Study Site
Amarillo, Texas, United States, 79109
Regeneron Study Site
Corpus Christi, Texas, United States, 78413
Regeneron Study Site
Dallas, Texas, United States, 75246
Regeneron Study Site
Dallas, Texas, United States, 75390
Regeneron Study Site
Houston, Texas, United States, 77004
Regeneron Study Site
Houston, Texas, United States, 77008
Regeneron Study Site
Houston, Texas, United States, 77030
Regeneron Study Site
Houston, Texas, United States, 77055
Regeneron Study Site
Houston, Texas, United States, 77057
Regeneron Study Site
Houston, Texas, United States, 77093
Regeneron Study Site
Pearland, Texas, United States, 77584
Regeneron Study Site
Red Oak, Texas, United States, 75154
Regeneron Study Site
San Antonio, Texas, United States, 78215
Regeneron Study Site
San Antonio, Texas, United States, 78217
Regeneron Study Site
San Antonio, Texas, United States, 78249
Regeneron Study Site
Tyler, Texas, United States, 75708
United States, Virginia
Regeneron Study Site
Falls Church, Virginia, United States, 22042
United States, Washington
Regeneron Study Site
Everett, Washington, United States, 98201
Regeneron Study Site
Seattle, Washington, United States, 98109
Regeneron Study Site
Seattle, Washington, United States, 98122
United States, Wisconsin
Regeneron Study Site
Madison, Wisconsin, United States, 53792
Mexico
Regeneron Study Site
Guadalajara, Jalisco, Mexico, 44280
Regeneron Study Site
Guadalajara, Jalisco, Mexico, 44340
Regeneron Study Site
Zapopan, Jalisco, Mexico, 45070
Regeneron Study Site
Monterrey, Nuevo Leon, Mexico, 64718
Regeneron Study Site
Monterrey, Nuevo León, Mexico, 64710
Regeneron Study Site
Merida, Yucatan, Mexico, 97070
Regeneron Study Site
Chihuahua, Mexico, 31238
Regeneron Study Site
Ciudad de Mexico, Mexico, 3100
Regeneron Study Site
Durango, Mexico, 34000
Regeneron Study Site
Mérida, Mexico, 97000
Regeneron Study Site
Veracruz, Mexico, 91900
Romania
Regeneron Study Site
Bucuresti, Romania, 021105

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] August 16, 2021

Statistical Analysis Plan [PDF] March 12, 2021

Informed Consent Form [PDF] August 12, 2020

More Information

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

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.

Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Xiao J, Hooper AT, Hamilton JD, Musser BJ, Rofail D, Hussein M, Im J, Atmodjo DY, Perry C, Pan C, Mahmood A, Hosain R, Davis JD, Turner KC, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Roque-Guerrero L, Acloque G, Aazami H, Cannon K, Simon-Campos JA, Bocchini JA, Kowal B, DiCioccio AT, Soo Y, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. N Engl J Med. 2021 Dec 2;385(23):e81. doi: 10.1056/NEJMoa2108163. Epub 2021 Sep 29.

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.

Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Musser BJ, Soo Y, Rofail D, Im J, Perry C, Pan C, Hosain R, Mahmood A, Davis JD, Turner KC, Hooper AT, Hamilton JD, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Kohli A, Sachdeva Y, Graber X, Kowal B, DiCioccio T, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):238-251. doi: 10.1056/NEJMoa2035002. Epub 2020 Dec 17.

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Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT04425629
Other Study ID Numbers:	R10933-10987-COV-2067 2020-003690-21 ( EudraCT Number )
First Posted:	June 11, 2020 Key Record Dates
Results First Posted:	December 21, 2023
Last Update Posted:	December 21, 2023
Last Verified:	December 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., Food and Drug Administration (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:


Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus

Additional relevant MeSH terms:

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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections 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

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