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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

Primary Purpose

COVID-19

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

casirivimab+imdevimab combination therapy

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

casirivimab+imdevimab low dose

Arm Description

Low dose or body-weight equivalent for those under 18 years of age.

Outcomes

Primary Outcome Measures

Proportion of patients with treatment-emergent serious adverse events (SAEs)

Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)

Proportion of patients with infusion-related reactions

Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)

Proportion of patients with hypersensitivity reactions

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), as measured by quantitative reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples

Primary: Phase 1, Phase 2 Secondary: Phase 3 (Cohort 1, for patients enrolled prior to protocol amendment 6 only), Phase 3 (Cohort 2)

Proportion of patients with at least one (≥1) COVID-19-related hospitalization or all-cause death

Primary: Phase 3 (Cohort 1) Secondary: Phase 3 (Cohort 2)

Concentration of REGN10933 in serum over time

Primary: Phase 3 (Cohort 2) Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)

Concentration of REGN10987 in serum over time

Primary: Phase 3 (Cohort 2) Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)

Secondary Outcome Measures

Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in saliva samples

Phase 1 Only

Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in nasal swab samples

Phase 1 Only

Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples

Phase 1 Only

Time to negative RT-qPCR in nasopharyngeal swabs with no subsequent positive RT-qPCR

Phase 2 Only

Change from baseline in viral load at each visit, as measured by RT-qPCR in nasopharyngeal swabs

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

Change from baseline in viral load at each visit, as measured by RT-qPCR in saliva samples

Phase 1 Only

Change from baseline in viral load at each visit, as measured by RT-qPCR in nasal swabs

Phase 1 Only

Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva)

Phase 1 Only

Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva)

Phase 1 Only

Time-weighted average change from baseline in viral load (log10 copies/mL) from day 1 to post-baseline study days

Phase 1, Phase 2

Proportion of participants with ≥1 COVID-19-related medically-attended visit

Phase 1, Phase 2

Proportion of participants with ≥2 COVID-19-related medically-attended visit

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

Total number of COVID-19-related medically-attended visits

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

Proportion of participants admitted to a hospital due to COVID-19

Phase 1, Phase 2

Proportion of participants with ≥1 outpatient or telemedicine visit due to COVID-19

Phase 1, Phase 2

Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933

Phase 1 Only

Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987

Phase 1 Only

Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933

Phase 1 Only

Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987

Phase 1 Only

Assessment of PK parameter: Time to Cmax (tmax) for REGN10933

Phase 1 Only

Assessment of PK parameter: Time to Cmax (tmax) for REGN10987

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

Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987

Phase 1 Only

Immunogenicity as measured by anti-drug (ADA) to REGN10933

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

Immunogenicity as measured by ADA to REGN10987

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

Immunogenicity as measured by neutralizing antibodies (NAbs) to REGN10933

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

Immunogenicity as measured by NAbs to REGN10987

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

Proportion of participants with high viral load at each visit

Phase 2 Only

Proportion of participants with viral loads below the limit of detection at each visit

Phase 2 Only

Proportion of participants with viral loads below the lower limit of quantitation at each visit

Phase 2 Only

Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19

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

Proportion of participants requiring mechanical ventilation due to COVID-19

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

Number of days of hospitalization due to COVID-19

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

Proportion of participants with all-cause mortality

Phase 2 Only

Time to first onset of symptoms consistent with COVID-19 (asymptomatic cohort only)

Phase 2 Only

Duration of symptoms consistent with COVID-19

Phase 2 Only

Proportion of participants with ≥1 COVID-19-related hospitalization or all-cause death

Phase 3 (Cohort 1 and Cohort 2)

Time to COVID-19 symptoms resolution

Phase 3 (Cohort 1)

Proportion of participants with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death

Phase 3 (Cohort 1 and Cohort 2)

Proportion of patients with (≥1) COVID-19-related medically-attended visit or all-cause death

Phase 3 (Cohort 1 and Cohort 2)

Proportion of participants with ≥1 COVID-19-related medically-attended visit by type of visit

Phase 3 (Cohort 1 and Cohort 2) Type of visit defined as hospitalization, emergency room, urgent care, and/or physician's office/telemedicine

Cumulative incidence of patients with ≥1 COVID-19-related hospitalization or all-cause death

Phase 3 (Cohort 1 and Cohort 2)

Cumulative incidence of patients with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death

Phase 3 (Cohort 1 and Cohort 2)

Cumulative incidence of patients with ≥1 COVID-19-related medically-attended visit or all-cause death

Phase 3 (Cohort 1 and Cohort 2)

Proportion of participants requiring supplemental oxygen due to COVID-19

Phase 3 (Cohort 1 and Cohort 2)

Time to all-cause death

Phase 3 (Cohort 1 and Cohort 2)

All-cause death

Phase 3 (Cohort 1 and Cohort 2)

Full Information

NCT ID

NCT04425629

First Posted

June 8, 2020

Last Updated

July 26, 2022

Sponsor

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04425629

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

Emerging SARS-CoV-2 variants impacting susceptibility to study drug

Study Start Date

June 16, 2020 (Actual)

Primary Completion Date

January 21, 2022 (Actual)

Study Completion Date

June 9, 2022 (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

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

6. Conditions and Keywords

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

COVID-19

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

Phase 1/Phase 2/Phase 3

Masking

None (Open Label)

Allocation

N/A

Enrollment

10078 (Actual)

8. Arms, Groups, and Interventions

Arm Title

casirivimab+imdevimab low dose

Arm Type

Experimental

Arm Description

Low dose or body-weight equivalent for those under 18 years of age.

Intervention Type

Drug

Intervention Name(s)

casirivimab+imdevimab combination therapy

Other Intervention Name(s)

REGN-COV2, REGN10933, REGN10987, REGEN-COV™, Ronapreve™

Intervention Description

Administered intravenously (IV) single dose

Primary Outcome Measure Information:

Title

Proportion of patients with treatment-emergent serious adverse events (SAEs)

Description

Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)

Time Frame

Through Day 29

Title

Proportion of patients with infusion-related reactions

Description

Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)

Time Frame

Through Day 4

Title

Proportion of patients with hypersensitivity reactions

Description

Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)

Time Frame

Through Day 29

Title

Description

Primary: Phase 1, Phase 2 Secondary: Phase 3 (Cohort 1, for patients enrolled prior to protocol amendment 6 only), Phase 3 (Cohort 2)

Time Frame

Baseline up to Day 7

Title

Proportion of patients with at least one (≥1) COVID-19-related hospitalization or all-cause death

Description

Primary: Phase 3 (Cohort 1) Secondary: Phase 3 (Cohort 2)

Time Frame

Through Day 29

Title

Concentration of REGN10933 in serum over time

Description

Primary: Phase 3 (Cohort 2) Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)

Time Frame

Through Day 29

Title

Concentration of REGN10987 in serum over time

Description

Primary: Phase 3 (Cohort 2) Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)

Time Frame

Through Day 29

Secondary Outcome Measure Information:

Title

Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in saliva samples

Description

Phase 1 Only

Time Frame

Baseline up to Day 22

Title

Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in nasal swab samples

Description

Phase 1 Only

Time Frame

Baseline up to Day 22

Title

Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples

Description

Phase 1 Only

Time Frame

Through Day 29

Title

Time to negative RT-qPCR in nasopharyngeal swabs with no subsequent positive RT-qPCR

Description

Phase 2 Only

Time Frame

Through Day 29

Title

Change from baseline in viral load at each visit, as measured by RT-qPCR in nasopharyngeal swabs

Description

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

Time Frame

Baseline up to Day 29

Title

Change from baseline in viral load at each visit, as measured by RT-qPCR in saliva samples

Description

Phase 1 Only

Time Frame

Baseline up to Day 29

Title

Change from baseline in viral load at each visit, as measured by RT-qPCR in nasal swabs

Description

Phase 1 Only

Time Frame

Baseline up to Day 29

Title

Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva)

Description

Phase 1 Only

Time Frame

Up to Day 29

Title

Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva)

Description

Phase 1 Only

Time Frame

Up to Day 29

Title

Time-weighted average change from baseline in viral load (log10 copies/mL) from day 1 to post-baseline study days

Description

Phase 1, Phase 2

Time Frame

Day 1 to Day 29

Title

Proportion of participants with ≥1 COVID-19-related medically-attended visit

Description

Phase 1, Phase 2

Time Frame

Through Day 29

Title

Proportion of participants with ≥2 COVID-19-related medically-attended visit

Description

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

Time Frame

Through Day 29

Title

Total number of COVID-19-related medically-attended visits

Description

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

Time Frame

Through Day 29

Title

Proportion of participants admitted to a hospital due to COVID-19

Description

Phase 1, Phase 2

Time Frame

Through Day 29

Title

Proportion of participants with ≥1 outpatient or telemedicine visit due to COVID-19

Description

Phase 1, Phase 2

Time Frame

Through Day 29

Title

Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933

Description

Phase 1 Only

Time Frame

Through Day 29

Title

Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987

Description

Phase 1 Only

Time Frame

Through Day 29

Title

Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933

Description

Phase 1 Only

Time Frame

Through Day 29

Title

Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987

Description

Phase 1 Only

Time Frame

Through Day 29

Title

Assessment of PK parameter: Time to Cmax (tmax) for REGN10933

Description

Phase 1 Only

Time Frame

Through Day 29

Title

Assessment of PK parameter: Time to Cmax (tmax) for REGN10987

Description

Phase 1 Only

Time Frame

Through Day 29

Title

Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933

Description

Phase 1 Only

Time Frame

Through Day 29

Title

Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987

Description

Phase 1 Only

Time Frame

Through Day 29

Title

Immunogenicity as measured by anti-drug (ADA) to REGN10933

Description

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

Time Frame

Through Day 29

Title

Immunogenicity as measured by ADA to REGN10987

Description

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

Time Frame

Through Day 29

Title

Immunogenicity as measured by neutralizing antibodies (NAbs) to REGN10933

Description

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

Time Frame

Through Day 29

Title

Immunogenicity as measured by NAbs to REGN10987

Description

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

Time Frame

Through Day 29

Title

Proportion of participants with high viral load at each visit

Description

Phase 2 Only

Time Frame

Through Day 29

Title

Proportion of participants with viral loads below the limit of detection at each visit

Description

Phase 2 Only

Time Frame

Through Day 29

Title

Proportion of participants with viral loads below the lower limit of quantitation at each visit

Description

Phase 2 Only

Time Frame

Through Day 29

Title

Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19

Description

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

Time Frame

Through Day 29

Title

Proportion of participants requiring mechanical ventilation due to COVID-19

Description

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

Time Frame

Through Day 29

Title

Number of days of hospitalization due to COVID-19

Description

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

Time Frame

Through Day 29

Title

Proportion of participants with all-cause mortality

Description

Phase 2 Only

Time Frame

Through Day 29

Title

Time to first onset of symptoms consistent with COVID-19 (asymptomatic cohort only)

Description

Phase 2 Only

Time Frame

Up to Day 29

Title

Duration of symptoms consistent with COVID-19

Description

Phase 2 Only

Time Frame

Up to Day 29

Title

Proportion of participants with ≥1 COVID-19-related hospitalization or all-cause death

Description

Phase 3 (Cohort 1 and Cohort 2)

Time Frame

From Day 4 Through Day 29

Title

Time to COVID-19 symptoms resolution

Description

Phase 3 (Cohort 1)

Time Frame

Through Day 29

Title

Proportion of participants with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death

Description

Phase 3 (Cohort 1 and Cohort 2)

Time Frame

Through day 29

Title

Proportion of patients with (≥1) COVID-19-related medically-attended visit or all-cause death

Description

Phase 3 (Cohort 1 and Cohort 2)

Time Frame

Through Day 29

Title

Proportion of participants with ≥1 COVID-19-related medically-attended visit by type of visit

Description

Phase 3 (Cohort 1 and Cohort 2) Type of visit defined as hospitalization, emergency room, urgent care, and/or physician's office/telemedicine

Time Frame

Through day 29

Title

Cumulative incidence of patients with ≥1 COVID-19-related hospitalization or all-cause death

Description

Phase 3 (Cohort 1 and Cohort 2)

Time Frame

Through Day 29

Title

Cumulative incidence of patients with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death

Description

Phase 3 (Cohort 1 and Cohort 2)

Time Frame

Through Day 29

Title

Cumulative incidence of patients with ≥1 COVID-19-related medically-attended visit or all-cause death

Description

Phase 3 (Cohort 1 and Cohort 2)

Time Frame

Through Day 29

Title

Proportion of participants requiring supplemental oxygen due to COVID-19

Description

Phase 3 (Cohort 1 and Cohort 2)

Time Frame

Through Day 29

Title

Time to all-cause death

Description

Phase 3 (Cohort 1 and Cohort 2)

Time Frame

Through Day 169

Title

All-cause death

Description

Phase 3 (Cohort 1 and Cohort 2)

Time Frame

By Day 29, Day 120, and Day 169

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or saliva) Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization Maintains O2 saturation ≥93% on room air Is able to understand and complete study-related questionnaires (patients aged ≥12 years only) Key Exclusion Criteria: Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational) Prior use (prior to randomization), current use (at randomization) or planned use (within 90 days of study drug administration or per current CDC recommendations, as applicable) of any authorized or approved vaccine for COVID-19 Has participated, is participating or plans to participate in a clinical research study evaluation any authorized, approved or investigational vaccine for COVID-19 NOTE: Other Protocol defined Inclusion/Exclusion criteria apply

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

Canoga Park

State/Province

California

ZIP/Postal Code

91303

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 1

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Regeneron Study Site 2

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Regeneron Study Site 3

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

90036

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

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

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

San Francisco

State/Province

California

ZIP/Postal Code

94127

Country

United States

Facility Name

Regeneron Study Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

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

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

20037

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

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

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 1

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Regeneron Study Site 2

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

33130

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

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

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

33606

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 Haven

State/Province

Florida

ZIP/Postal Code

33880

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

30309

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

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

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

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

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 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

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

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

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

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70114

Country

United States

Facility Name

Regeneron Study Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71118

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

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

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

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

Regeneron Study Site

City

Ridgewood

State/Province

New Jersey

ZIP/Postal Code

07450

Country

United States

Facility Name

Regeneron Study Site

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

Regeneron Study Site

City

Santa Fe

State/Province

New Mexico

ZIP/Postal Code

87505

Country

United States

Facility Name

Regeneron Study Site

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

Jamaica

State/Province

New York

ZIP/Postal Code

11432

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10025

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

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

Regeneron Study Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

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

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Regeneron Study Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45409

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

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Regeneron Study Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

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

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57108

Country

United States

Facility Name

Regeneron Study Site 2

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38103

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

Amarillo

State/Province

Texas

ZIP/Postal Code

79109

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

75246

Country

United States

Facility Name

Regeneron Study Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Regeneron Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

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

77030

Country

United States

Facility Name

Regeneron Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77055

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

78215

Country

United States

Facility Name

Regeneron Study Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

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

75708

Country

United States

Facility Name

Regeneron Study Site

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

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

98109

Country

United States

Facility Name

Regeneron Study Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

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

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

Regeneron Study Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

Facility Name

Regeneron Study Site

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45070

Country

Mexico

Facility Name

Regeneron Study Site

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64718

Country

Mexico

Facility Name

Regeneron Study Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64710

Country

Mexico

Facility Name

Regeneron Study Site

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Regeneron Study Site

City

Chihuahua

ZIP/Postal Code

31238

Country

Mexico

Facility Name

Regeneron Study Site

City

Ciudad de Mexico

ZIP/Postal Code

3100

Country

Mexico

Facility Name

Regeneron Study Site

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

Regeneron Study Site

City

Mérida

ZIP/Postal Code

97000

Country

Mexico

Facility Name

Regeneron Study Site

City

Veracruz

ZIP/Postal Code

91900

Country

Mexico

Facility Name

Regeneron Study Site

City

Bucuresti

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., 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).

IPD Sharing URL

https://vivli.org/

Citations:

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

34587383

Citation

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

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

33332778

Citation

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

Results Reference

derived

Learn more about this trial

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

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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

COVID-19

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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

Learn more about this trial