COVID-19 Study to Evaluate Safety, Tolerability, and Effi... | NCT05081388

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
REGN14256 + imdevimab	Experimental	Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1 Phase 3: (Open label) (≥12 and <18 Years)	Drug: REGN14256 Drug: imdevimab
REGN14256	Experimental	Phase 1, Phase 2: Randomized 1:1:1:1:1	Drug: REGN14256
Imdevimab	Experimental	Phase 1, Phase 2: Randomized 1:1:1:1:1	Drug: imdevimab
casirivimab + imdevimab	Experimental	Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1	Drug: imdevimab Drug: casirivimab + imdevimab
Placebo	Experimental	Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
REGN14256	Drug	Sub-cutaneous (SC) single dose	REGN14256 REGN14256 + imdevimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment Emergent Adverse Events (TEAEs)	Phase 1	Through Day 29
Severity of TEAEs	Severity was based on Grading. Grade 1 was less severe. Grade 5 was more severe. - Mild; Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated - Moderate; Minimal, local, or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL) - Severe; Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; ADL2 limiting self-care - Life-threatening; Life threatening consequences; urgent intervention indicated - Death; Death related to adverse events	Through Day 29
Percentage of Participants With Injection-site Reactions (ISRs)	Phase 1 only	Through Day 169
Severity of ISRs (Injection Site Reactions)	Severity was based on Grading. Grade 1 was less severe. Grade 5 was more severe. Grade 1 - Tenderness with or without associated symptoms (eg, warmth, erythema, itching) Grade 2 - Pain; lipodystrophy; edema; phlebitis Grade 3 - Ulceration or necrosis; severe tissue damage; operative intervention indicated Grade 4 - Life-threatening consequences; urgent intervention indicated Grade 5 - Death	Through Day 29
Percentage of Participants With Hypersensitivity Reactions	Phase 1	Through Day 169
Severity of Hypersensitivity Reactions Over Time	Grade 1 - Systemic intervention not indicated. Grade 2 - Oral intervention indicated Grade 3 - Bronchospasm; hospitalization indicated for clinical sequelae; intravenous intervention indicated Grade 4 - Life-threatening consequences; urgent intervention indicated Grade 5 - Death

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)	Phase 1	Through Day 169
TEAEs (Treatment-Emergent Adverse Events)	Phase 2 and Phase 3

Eligibility Module

Eligibility Criteria

Phase 1 will enroll adult patients (≥18 years of age), Phase 2 will enroll adult patients, Phase 3 will enroll adult patients and an additional adolescent cohort of patients (≥12 and <18 years of age)

Key Inclusion Criteria:

For the adolescent cohort in Phase 3 only: Weighs ≥40 kg at randomization
Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARSCoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization. A historical record of a positive result is acceptable as long as the sample was collected ≤72 hours prior to randomization
Has symptoms consistent with COVID-19 (as determined by the investigator) with onset ≤7 days before randomization, and doesn't have a medical condition or other factors associated with high risk for progression to severe COVID-19 as outlined in the exclusion criteria
Maintains O2 saturation ≥93% on room air

Key Exclusion Criteria:

Has a medical condition or other factors associated with high risk for progression to severe COVID-19:
1. Cancer
2. Cardiovascular disease (such as heart failure, coronary artery disease, cardiomyopathies, congenital heart disease or hypertension)
3. Chronic lung disease including chronic obstructive pulmonary disease, asthma (moderate to severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension
4. Chronic kidney disease at any stage
5. Chronic liver disease (such as alcohol-related, nonalcoholic fatty liver disease, cirrhosis)
6. Dementia or other chronic neurological condition
7. Diabetes mellitus (type 1 or type 2)
8. Immunodeficiency disease or taking immunosuppressive treatment
9. Medical-related technological dependence [for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)]
10. Neurodevelopmental disorder (for example, cerebral palsy) or other condition that confers medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
11. Overweight (defined as BMI >25 kg/m2) or obesity (defined as BMI ≥30 kg/m2)
12. Poorly controlled HIV infection or AIDS
13. Pregnancy
14. Sickle cell disease or thalassemia
15. Stroke or cerebrovascular disease
Prior, current (at randomization) or planned use (within time period given per CDC guidance [90 days]) of any authorized or approved vaccine for COVID-19
Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
Has a known prior SARS-CoV-2 infection or positive SARS-CoV-2 serologic test
Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected >72 hours prior to randomization
Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, 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 any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test
Has been discharged, or is planned to be discharged, to a quarantine center
Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19
For Phase 1only: Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and for at least 6 months after study drug administration as described in the protocol

Note: Other protocol-defined inclusion/ exclusion criteria apply

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Regeneron Research Site		La Mesa	California	91941	United States
Ark Clinical Research

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
FG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 6, 2021	Jun 29, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Treatment Emergent Adverse Events (TEAEs)

Phase 1

The study was terminated in the Phase 1 portion of the study. The Safety Analysis Set (SAF) includes all randomized participants who received any study drug; it is based on the treatment received. Only Phase 1 data was collected. Phase 2 and Phase 3 portions of the study were never opened.

Posted

Number

Events

Through Day 29

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	REGN14256 + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened

Units	Counts
Participants	OG0003 OG0015 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0013 OG0021 OG003

Primary

Severity of TEAEs

Severity was based on Grading. Grade 1 was less severe. Grade 5 was more severe.

- Mild; Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
- Moderate; Minimal, local, or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL)
- Severe; Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; ADL2 limiting self-care
- Life-threatening; Life threatening consequences; urgent intervention indicated
- Death; Death related to adverse events

Posted

Number

Participants

Through Day 29

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)

Primary

Percentage of Participants With Injection-site Reactions (ISRs)

Phase 1 only

The Safety Analysis Set (SAF) includes all randomized participants who received any study drug; it is based on the treatment received. The study was terminated during Phase 1. Only Phase 1 data was collected. Phase 2 and Phase 3 portions of the study were never opened.

Posted

Number

Percentage of Participants

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened

Primary

Severity of ISRs (Injection Site Reactions)

Severity was based on Grading. Grade 1 was less severe. Grade 5 was more severe.

Grade 1 - Tenderness with or without associated symptoms (eg, warmth, erythema, itching) Grade 2 - Pain; lipodystrophy; edema; phlebitis Grade 3 - Ulceration or necrosis; severe tissue damage; operative intervention indicated Grade 4 - Life-threatening consequences; urgent intervention indicated Grade 5 - Death

Posted

Number

Events

Through Day 29

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003

Primary

Percentage of Participants With Hypersensitivity Reactions

Phase 1

Posted

Number

Percentage of Participants

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened

Primary

Severity of Hypersensitivity Reactions Over Time

Grade 1 - Systemic intervention not indicated. Grade 2 - Oral intervention indicated Grade 3 - Bronchospasm; hospitalization indicated for clinical sequelae; intravenous intervention indicated Grade 4 - Life-threatening consequences; urgent intervention indicated Grade 5 - Death

The study was terminated in the Phase 1 portion of the study. The Safety Analysis Set (SAF) includes all randomized participants who received any study drug; it is based on the treatment received. Phase 2 and Phase 3 portions of the study were never opened.

Posted

Number

Events

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)

Primary

Time-weighted Average (TWA) Daily Change From Baseline in Viral Load (log10 Copies/mL)

Phase 1 Measured by SARS-CoV-2 quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples

The modified full analysis set (mFAS) includes all randomized patients with a positive central lab determined SARS-CoV-2 RT-qPCR result from nasopharyngeal (NP) swab samples at randomization and is based on the treatment received. The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened.

Posted

Mean

Standard Deviation

log10 copies/mL

Day 1 to day 7

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)

Secondary

Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Phase 1

The Safety Analysis Set (SAF) includes all randomized participants who received any study drug; it is based on the treatment received. The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened.

Posted

Number

Percentage

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004

Secondary

TEAEs (Treatment-Emergent Adverse Events)

Phase 2 and Phase 3

Posted

Through Day 29

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	REGN14256 + Imdevimab (1200 mg SC)

Secondary

Severity of TEAEs (Treatment-Emergent Adverse Event)

Phase 2 and Phase 3

Posted

Through Day 29

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	REGN14256 + Imdevimab (1200 mg SC)

Secondary

Percentage of Participants With ISRs (Injection-Site Reactions)

Phase 2 and Phase 3

Posted

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	REGN14256 + Imdevimab (1200 mg SC)

Secondary

Severity of ISRs (Injection-Site Reactions)

Phase 2 and Phase 3

Posted

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	REGN14256 + Imdevimab (1200 mg SC)

Secondary

Percentage of Participants With Hypersensitivity Reactions

Phase 2 and Phase 3

Posted

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	REGN14256 + Imdevimab (1200 mg SC)

Secondary

Severity of Hypersensitivity Reactions Over Time

Phase 2 and Phase 3

Posted

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	REGN14256 + Imdevimab (1200 mg SC)

Secondary

Percentage of Participants With Treatment-emergent SAEs (Serious Adverse Events)

Phase 2 and Phase 3

The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened

Posted

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	REGN14256 + Imdevimab (1200 mg SC)

Secondary

Time-weighted Average Change From Baseline in Viral Load

Phase 2 and Phase 3

Time-weighted average (TWA) daily change from baseline in viral load (log10 copies/mL) as measured by SARS-CoV-2 quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened. No data collected.

Posted

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 2 and Phase 3 portions of the study were never opened
OG004

Secondary

Change From Baseline in Viral Load (Phase 1)

Phase 1 Change from baseline in viral load (log10 copies/mL) as measured by SARS-CoV-2 quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

Posted

Mean

Standard Deviation

log10 copies/mL

Through Day 7

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)

Secondary

Change From Baseline in Viral Load

Phase 2, and Phase 3 As measured by RT-qPCR in NP samples

The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened. No data collected.

Posted

Through Day 7

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	REGN14256 + Imdevimab (1200 mg SC)

Secondary

Percentage of Participants With Viral Loads Below the Limit of Detection

Phase 1, Phase 2, and Phase 3

The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened. No data collected.

Posted

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	REGN14256 + Imdevimab (1200 mg SC)

Secondary

Concentrations of REGN14256 in Serum Over Time (Phase 1)

Phase 1

The PK analysis set includes all treated participants who received REGN14256 and who had at least 1 non-missing result of respective analyte following the first dose of REGN14256. The study was terminated, data was not collected for Phase 2 and Phase 3, as these portions were never opened.

Posted

Mean

Standard Deviation

mg/L

Through Day 169

ID	Title	Description
OG000	REGN14256 600 mg SC	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	REGN14256+Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened

Units	Counts
Participants	OG000

Secondary

Concentrations of REGN14256 in Serum Over Time

Phase 2 and Phase 3

The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened. No data collected.

Posted

Through Day 169

ID	Title	Description
OG000	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	REGN14256 + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened

Units	Counts
Participants	OG000

Secondary

Concentrations of Imdevimab in Serum Over Time (Phase 1)

Phase 1

The PK analysis set includes all treated participants who received imdevimab and who had at least 1 non-missing result of respective analyte following the first dose of imdevimab. The study was terminated, data was not collected for Phase 2 and Phase 3, as these portions were never opened.

Posted

Mean

Standard Deviation

mg/L

Through Day 169

ID	Title	Description
OG000	Imdevimab 600 mg SC	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	Casirivimab+Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256+Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened

Units	Counts
Participants

Secondary

Concentrations of Imdevimab in Serum Over Time

Phase 2 and Phase 3

The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened. No data collected.

Posted

Through Day 169

ID	Title	Description
OG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG001	REGN14256 + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG003	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
OG004	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened

Secondary

Incidence and Titer of Anti-drug Antibodies (ADA) to REGN14256 Over Time

Phase 1, Phase 2, and Phase 3

As prespecified within the SAP (statistical analysis plan), ADA sample analysis was not performed due to early study termination; therefore, ADA analysis data was not generated. No data collected.

Posted

Through Day 169

ID	Title	Description
OG000	Placebo	Placebo
OG001	Imdevimab (600 mg SC)	Imdevimab 600 mg administered subcutaneously
OG002	REGN14256 (600 mg SC)	REGN14256 600 mg administered subcutaneously
OG003	Casirivimab + Imdevimab (1200 mg SC)	Casirivimab + Imdevimab 1200 mg administered subcutaneously
OG004	REGN14256 + Imdevimab (1200 mg SC)	REGN14256 + Imdevimab 1200 mg administered subcutaneously

Secondary

Incidence and Titer of ADA to Imdevimab Over Time

Phase 1, Phase 2, and Phase 3

As prespecified within the SAP (statistical analysis plan), ADA sample analysis was not performed due to early study termination; therefore, ADA analysis data was not generated. No data collected.

Posted

Through Day 169

ID	Title	Description
OG000	Placebo	Placebo
OG001	Imdevimab (600 mg SC)	Imdevimab (600 mg SC)
OG002	REGN14256 (600 mg SC)	REGN14256 (600 mg SC)
OG003	Casirivimab + Imdevimab (1200 mg SC)	Casirivimab + Imdevimab (1200 mg SC)
OG004	REGN14256 + Imdevimab (1200 mg SC)	REGN14256 + Imdevimab (1200 mg SC)

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected5 at risk EG0020 events0 affected6 at risk EG0030 events0 affected4 at risk EG0041 events1 affected6 at risk
Tonsillitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk EG003
Wound infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk EG003
Chills	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk EG003
Injection site reaction	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk EG003
Pyrexia	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk EG003

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
BG001	Imdevimab (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
BG002	REGN14256 (600 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
BG003	Casirivimab + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
BG004	REGN14256 + Imdevimab (1200 mg SC)	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
BG005	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened	3	1	3	1	3
EG001	Imdevimab 600 mg SC	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened	5	1	5	2	5
EG002	REGN14256 600 mg SC	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened	6	0	6	1	6
EG003	REGN14256+Imdevimab 1200 mg SC	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened	4	0	4	2	4
EG004	Casirivimab+Imdevimab 1200 mg SC	Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened	6	0	6	1	6

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment		EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk EG0030 events0 affected4 at risk EG0040 events0 affected6 at risk
Arthritis bacterial	Infections and infestations	MedDRA (25.0)	Systematic Assessment		EG0001 events1 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk EG003

ID	Term
C000719811	REGN14256
C000711488	imdevimab
C000711751	casirivimab and imdevimab drug combination
C000711487	casirivimab