Trial Outcomes & Findings for COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease (NCT NCT05081388)
NCT ID: NCT05081388
Last Updated: 2025-10-28
Results Overview
Phase 1
TERMINATED
PHASE1/PHASE2
25 participants
Through Day 29
2025-10-28
Participant Flow
The study was initiated in November 2021, however, due to the reduced activity of REGN14256+imdevimab against the emerging Omicron variant and not due to any safety concerns, study enrollment was paused and later terminated. As a result, only 25 participants were randomized into the phase 1 portion of the study and the phase 2 and phase 3 portions of the study were never opened.
The study was initiated in November 2021, however, due to the reduced activity of REGN14256+imdevimab against the emerging Omicron variant and not due to any safety concerns, study enrollment was paused and later terminated. As a result, only 25 participants were randomized into the phase 1 portion of the study and the phase 2 and phase 3 portions of the study were never opened
Participant milestones
| Measure |
Placebo
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
6
|
6
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
6
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Subject decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=5 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.8 Years
STANDARD_DEVIATION 1.50 • n=5 Participants
|
50.4 Years
STANDARD_DEVIATION 14.05 • n=7 Participants
|
38.2 Years
STANDARD_DEVIATION 19.81 • n=5 Participants
|
30.3 Years
STANDARD_DEVIATION 7.87 • n=4 Participants
|
42.0 Years
STANDARD_DEVIATION 9.90 • n=21 Participants
|
37.4 Years
STANDARD_DEVIATION 14.63 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Through Day 29Population: 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.
Phase 1
Outcome measures
| Measure |
Placebo
n=3 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=5 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Treatment Emergent Adverse Events (TEAEs)
|
1 Events
|
3 Events
|
1 Events
|
1 Events
|
2 Events
|
PRIMARY outcome
Timeframe: Through Day 29Population: 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.
Severity was based on Grading. Grade 1 was less severe. Grade 5 was more severe. 1. \- Mild; Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated 2. \- Moderate; Minimal, local, or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL) 3. \- Severe; Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; ADL2 limiting self-care 4. \- Life-threatening; Life threatening consequences; urgent intervention indicated 5. \- Death; Death related to adverse events
Outcome measures
| Measure |
Placebo
n=3 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=5 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Severity of TEAEs
With at least one Grade 1 TEAE
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Severity of TEAEs
With at least one Grade 2 TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of TEAEs
With at least one Grade 3 TEAE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of TEAEs
With at least one Grade 4 TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of TEAEs
With at least one Grade 5 TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Day 169Population: 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.
Phase 1 only
Outcome measures
| Measure |
Placebo
n=3 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=5 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Percentage of Participants With Injection-site Reactions (ISRs)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Through Day 29Population: 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.
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
Outcome measures
| Measure |
Placebo
n=3 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=5 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Severity of ISRs (Injection Site Reactions)
With at least one Grade 1 ISR
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
|
Severity of ISRs (Injection Site Reactions)
With at least one Grade 2 ISR
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Severity of ISRs (Injection Site Reactions)
With at least one Grade 3 ISR
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Severity of ISRs (Injection Site Reactions)
With at least one Grade 4 ISR
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Severity of ISRs (Injection Site Reactions)
With at least one Grade 5 ISR
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
PRIMARY outcome
Timeframe: Through Day 169Population: 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.
Phase 1
Outcome measures
| Measure |
Placebo
n=3 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=5 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Percentage of Participants With Hypersensitivity Reactions
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Through Day 169Population: 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.
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
Outcome measures
| Measure |
Placebo
n=3 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=5 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Severity of Hypersensitivity Reactions Over Time
With at least one Grade 1
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Severity of Hypersensitivity Reactions Over Time
With at least one Grade 2
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Severity of Hypersensitivity Reactions Over Time
With at least one Grade 3
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Severity of Hypersensitivity Reactions Over Time
With at least one Grade 4
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Severity of Hypersensitivity Reactions Over Time
With at least one Grade 5
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
PRIMARY outcome
Timeframe: Day 1 to day 7Population: 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.
Phase 1 Measured by SARS-CoV-2 quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples
Outcome measures
| Measure |
Placebo
n=3 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
n=2 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Time-weighted Average (TWA) Daily Change From Baseline in Viral Load (log10 Copies/mL)
|
-4.02 log10 copies/mL
Standard Deviation 1.461
|
-2.28 log10 copies/mL
Standard Deviation 0.286
|
-2.30 log10 copies/mL
Standard Deviation 0.964
|
-2.72 log10 copies/mL
Standard Deviation 1.517
|
-1.76 log10 copies/mL
Standard Deviation 0.003
|
SECONDARY outcome
Timeframe: Through Day 169Population: 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.
Phase 1
Outcome measures
| Measure |
Placebo
n=3 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=5 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)
|
33.3 Percentage
|
20.0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
SECONDARY outcome
Timeframe: Through Day 29Population: 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. No data collected.
Phase 2 and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 29Population: 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. No data collected.
Phase 2 and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: 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. No data collected.
Phase 2 and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: 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. No data collected.
Phase 2 and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: 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. No data collected.
Phase 2 and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: 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. No data collected.
Phase 2 and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened
Phase 2 and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened. No data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 7Population: 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
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.
Outcome measures
| Measure |
Placebo
n=3 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=5 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
n=2 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Change From Baseline in Viral Load (Phase 1)
Change from Baseline to Day 3
|
-3.93 log10 copies/mL
Standard Deviation 2.691
|
-2.14 log10 copies/mL
Standard Deviation 0.251
|
-1.60 log10 copies/mL
Standard Deviation 1.598
|
-2.27 log10 copies/mL
Standard Deviation 1.097
|
0.23 log10 copies/mL
Standard Deviation NA
Too small a number of data points calculate
|
|
Change From Baseline in Viral Load (Phase 1)
Change from Baseline to Day 5
|
-5.25 log10 copies/mL
Standard Deviation 1.400
|
-3.74 log10 copies/mL
Standard Deviation 1.585
|
-3.28 log10 copies/mL
Standard Deviation 1.085
|
-3.73 log10 copies/mL
Standard Deviation 2.677
|
-1.88 log10 copies/mL
Standard Deviation NA
Too small a number of data points calculate
|
|
Change From Baseline in Viral Load (Phase 1)
Change from Baseline to Day 7
|
-5.76 log10 copies/mL
Standard Deviation 2.220
|
-3.02 log10 copies/mL
Standard Deviation 1.115
|
-4.01 log10 copies/mL
Standard Deviation 2.000
|
-4.31 log10 copies/mL
Standard Deviation 2.121
|
-5.37 log10 copies/mL
Standard Deviation 2.617
|
SECONDARY outcome
Timeframe: Through Day 7Population: The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened. No data collected.
Phase 2, and Phase 3 As measured by RT-qPCR in NP samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened. No data collected.
Phase 1, Phase 2, and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: 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.
Phase 1
Outcome measures
| Measure |
Placebo
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Concentrations of REGN14256 in Serum Over Time (Phase 1)
Pre-dose
|
0 mg/L
Standard Deviation 0
|
0 mg/L
Standard Deviation 0
|
—
|
—
|
—
|
|
Concentrations of REGN14256 in Serum Over Time (Phase 1)
Post-dose
|
3.45 mg/L
Standard Deviation 4.36
|
9.66 mg/L
Standard Deviation 10.6
|
—
|
—
|
—
|
|
Concentrations of REGN14256 in Serum Over Time (Phase 1)
Day 1
|
21.5 mg/L
Standard Deviation 16.6
|
52.4 mg/L
Standard Deviation 43.3
|
—
|
—
|
—
|
|
Concentrations of REGN14256 in Serum Over Time (Phase 1)
Day 2
|
37.5 mg/L
Standard Deviation 25.4
|
58.5 mg/L
Standard Deviation 38.3
|
—
|
—
|
—
|
|
Concentrations of REGN14256 in Serum Over Time (Phase 1)
Day 6
|
53.2 mg/L
Standard Deviation 29.9
|
63.6 mg/L
Standard Deviation 26.2
|
—
|
—
|
—
|
|
Concentrations of REGN14256 in Serum Over Time (Phase 1)
Day 28
|
30.7 mg/L
Standard Deviation 15.7
|
39.9 mg/L
Standard Deviation 14.6
|
—
|
—
|
—
|
|
Concentrations of REGN14256 in Serum Over Time (Phase 1)
Day 59
|
13.5 mg/L
Standard Deviation 7.57
|
19.6 mg/L
Standard Deviation 5.78
|
—
|
—
|
—
|
|
Concentrations of REGN14256 in Serum Over Time (Phase 1)
Day 89
|
7.30 mg/L
Standard Deviation 4.46
|
9.03 mg/L
Standard Deviation 3.43
|
—
|
—
|
—
|
|
Concentrations of REGN14256 in Serum Over Time (Phase 1)
Day 119
|
3.44 mg/L
Standard Deviation 2.42
|
4.23 mg/L
Standard Deviation 1.73
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 169Population: The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened. No data collected.
Phase 2 and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: 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.
Phase 1
Outcome measures
| Measure |
Placebo
n=5 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab (600 mg SC)
n=6 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 (600 mg SC)
n=4 Participants
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab + Imdevimab (1200 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 + Imdevimab (1200 mg SC)
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Concentrations of Imdevimab in Serum Over Time (Phase 1)
Day 28
|
18.9 mg/L
Standard Deviation 9.94
|
27.9 mg/L
Standard Deviation 8.34
|
20.8 mg/L
Standard Deviation 12.2
|
—
|
—
|
|
Concentrations of Imdevimab in Serum Over Time (Phase 1)
Pre-dose
|
2.46 mg/L
Standard Deviation 3.59
|
0.398 mg/L
Standard Deviation 0.976
|
0.360 mg/L
Standard Deviation 0.720
|
—
|
—
|
|
Concentrations of Imdevimab in Serum Over Time (Phase 1)
Post-dose
|
3.43 mg/L
Standard Deviation 3.13
|
3.06 mg/L
Standard Deviation 2.36
|
9.03 mg/L
Standard Deviation 6.47
|
—
|
—
|
|
Concentrations of Imdevimab in Serum Over Time (Phase 1)
Day 1
|
19.7 mg/L
Standard Deviation 9.74
|
31.2 mg/L
Standard Deviation 10.5
|
27.9 mg/L
Standard Deviation 21.0
|
—
|
—
|
|
Concentrations of Imdevimab in Serum Over Time (Phase 1)
Day 2
|
28.4 mg/L
Standard Deviation 6.08
|
40.7 mg/L
Standard Deviation 11.8
|
31.9 mg/L
Standard Deviation 19.2
|
—
|
—
|
|
Concentrations of Imdevimab in Serum Over Time (Phase 1)
Day 6
|
42.7 mg/L
Standard Deviation 16.8
|
52.2 mg/L
Standard Deviation 16.3
|
38.8 mg/L
Standard Deviation 7.59
|
—
|
—
|
|
Concentrations of Imdevimab in Serum Over Time (Phase 1)
Day 59
|
7.66 mg/L
Standard Deviation 3.68
|
10.3 mg/L
Standard Deviation 4.40
|
7.18 mg/L
Standard Deviation 3.75
|
—
|
—
|
|
Concentrations of Imdevimab in Serum Over Time (Phase 1)
Day 89
|
3.26 mg/L
Standard Deviation 1.80
|
4.37 mg/L
Standard Deviation 2.12
|
3.73 mg/L
Standard Deviation 2.46
|
—
|
—
|
|
Concentrations of Imdevimab in Serum Over Time (Phase 1)
Day 119
|
1.72 mg/L
Standard Deviation 1.06
|
2.60 mg/L
Standard Deviation 1.52
|
2.68 mg/L
Standard Deviation 0.910
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 169Population: The study was terminated, and Phase 2 and Phase 3 portions of the study were never opened. No data collected.
Phase 2 and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: 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.
Phase 1, Phase 2, and Phase 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 169Population: 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.
Phase 1, Phase 2, and Phase 3
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Imdevimab 600 mg SC
REGN14256 600 mg SC
REGN14256+Imdevimab 1200 mg SC
Casirivimab+Imdevimab 1200 mg SC
Serious adverse events
| Measure |
Placebo
n=3 participants at risk
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab 600 mg SC
n=5 participants at risk
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 600 mg SC
n=6 participants at risk
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256+Imdevimab 1200 mg SC
n=4 participants at risk
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab+Imdevimab 1200 mg SC
n=6 participants at risk
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From first dose to end of study (Up to 169 days)
|
20.0%
1/5 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
|
Infections and infestations
Arthritis bacterial
|
33.3%
1/3 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
Other adverse events
| Measure |
Placebo
n=3 participants at risk
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Imdevimab 600 mg SC
n=5 participants at risk
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256 600 mg SC
n=6 participants at risk
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
REGN14256+Imdevimab 1200 mg SC
n=4 participants at risk
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
Casirivimab+Imdevimab 1200 mg SC
n=6 participants at risk
Phase 1 only. Phase 2 and Phase 3 portions of the study were never opened
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From first dose to end of study (Up to 169 days)
|
40.0%
2/5 • Number of events 2 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
16.7%
1/6 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • From first dose to end of study (Up to 169 days)
|
20.0%
1/5 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
|
Infections and infestations
Wound infection
|
33.3%
1/3 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From first dose to end of study (Up to 169 days)
|
20.0%
1/5 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
16.7%
1/6 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
16.7%
1/6 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
|
General disorders
Chills
|
0.00%
0/3 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
16.7%
1/6 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
25.0%
1/4 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
25.0%
1/4 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
33.3%
1/3 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
|
Investigations
Blood creatine phosphokinase increased
|
33.3%
1/3 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
0.00%
0/4 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From first dose to end of study (Up to 169 days)
|
0.00%
0/5 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
25.0%
1/4 • Number of events 1 • From first dose to end of study (Up to 169 days)
|
0.00%
0/6 • From first dose to end of study (Up to 169 days)
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER