COVID-19Phase 3NCT04425629
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
A Phase 3 study testing casirivimab+imdevimab combination therapy in people with COVID-19, run by Regeneron Pharmaceuticals at 114 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- casirivimab+imdevimab combination therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,078 participants
- Where
- 114 sitesin 3 countries
- Study dates
- 16 Jun 2020to 9 Jun 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
114 sites in 3 countries.
114 sites in 3 countries
United States102 sites
Regeneron Study Site
Amarillo, Texas, 79109
Regeneron Study Site
Ames, Iowa, 50010-3014
Regeneron Study Site
Atlanta, Georgia, 30309
Regeneron Study Site
Atlanta, Georgia, 30322
Regeneron Study Site
Augusta, Georgia, 30912
Regeneron Study Site
Aurora, Colorado, 80045
Regeneron Study Site
Baltimore, Maryland, 21201
Regeneron Study Site
Boca Raton, Florida, 33487
Regeneron Study Site
Canoga Park, California, 91303
Regeneron Study Site
Charleston, South Carolina, 29425
Regeneron Study Site
Charlotte, North Carolina, 28209
Regeneron Study Site
Chicago, Illinois, 60607
Regeneron Study Site
Clinton, South Carolina, 29325
Regeneron Study Site
Colorado Springs, Colorado, 80907
Regeneron Study Site
Columbus, Georgia, 31904
Regeneron Study Site
Columbus, Ohio, 43215
Regeneron Study Site
Corpus Christi, Texas, 78413
Regeneron Study Site
Dallas, Texas, 75246
Regeneron Study Site
Dallas, Texas, 75390
Regeneron Study Site
Dayton, Ohio, 45409
Regeneron Study Site
Dayton, Ohio, 45432
Regeneron Study Site
DeLand, Florida, 32720
Regeneron Study Site 1
Downers Grove, Illinois, 60515
Regeneron Study Site 2
Downers Grove, Illinois, 60515
Regeneron Study Site
Downers Grove, Illinois, 60515
Regeneron Study Site
Durham, North Carolina, 27710
Regeneron Study Site
Everett, Washington, 98201
Regeneron Study Site
Falls Church, Virginia, 22042
Regeneron Study Site
Ft. Pierce, Florida, 34982
Regeneron Study Site
Hialeah, Florida, 33010
Regeneron Study Site
Houston, Texas, 77004
Regeneron Study Site
Houston, Texas, 77008
Regeneron Study Site
Houston, Texas, 77030
Regeneron Study Site
Houston, Texas, 77055
Regeneron Study Site
Houston, Texas, 77057
Regeneron Study Site
Houston, Texas, 77093
Regeneron Study Site
Iowa City, Iowa, 52242
Regeneron Study Site
Jackson, Mississippi, 39216
Regeneron Study Site
Jamaica, New York, 11432
Regeneron Study Site
La Mesa, California, 91942
Regeneron Study Site
La Palma, California, 90623
Regeneron Study Site
Lake Charles, Louisiana, 70601
Regeneron Study Site
Las Vegas, Nevada, 89109
Regeneron Study Site 1
Long Beach, California, 90806
Regeneron Study Site 2
Long Beach, California, 90806
Regeneron Study Site 3
Long Beach, California, 90806
Regeneron Study Site
Los Angeles, California, 90036
Regeneron Study Site
Loxahatchee Groves, Florida, 33470
Regeneron Study Site
Madison, Wisconsin, 53792
Regeneron Study Site
Maitland, Florida, 32751
Regeneron Study Site
Marietta, Georgia, 30060
Regeneron Study Site
Marrero, Louisiana, 70072
Regeneron Study Site 2
Memphis, Tennessee, 38103
Regeneron Study Site
Memphis, Tennessee, 38103
Regeneron Study Site
Mesa, Arizona, 85210
Regeneron Study Site
Miami, Florida, 33012
Regeneron Study Site 1
Miami, Florida, 33126
Regeneron Study Site 2
Miami, Florida, 33126
Regeneron Study Site
Miami, Florida, 33130
Regeneron Study Site
Miami, Florida, 33144
Regeneron Study Site
Miami, Florida, 33184
Regeneron Study Site
Montclair, California, 91763
Regeneron Study Site
New Orleans, Louisiana, 70114
Regeneron Study Site
New York, New York, 10003
Regeneron Study Site
New York, New York, 10019
Regeneron Study Site
New York, New York, 10025
Regeneron Study Site
New York, New York, 10029
Regeneron Study Site
New York, New York, 10032
Regeneron Study Site
New York, New York, 10037
Regeneron Study Site
Pearland, Texas, 77584
Regeneron Study Site
Philadelphia, Pennsylvania, 19140
Regeneron Study Site
Providence, Rhode Island, 02903
Regeneron Study Site
Red Oak, Texas, 75154
Regeneron Study Site
Ridgewood, New Jersey, 07450
Regeneron Study Site
Rolling Hills Estates, California, 90274
Regeneron Study Site
Royal Oak, Michigan, 48073
Regeneron Study Site
Sacramento, California, 95817
Regeneron Study Site
San Antonio, Texas, 78215
Regeneron Study Site
San Antonio, Texas, 78217
Regeneron Study Site
San Antonio, Texas, 78249
Regeneron Study Site
San Francisco, California, 94127
Regeneron Study Site
Santa Fe, New Mexico, 87505
Regeneron Study Site
Santa Monica, California, 90404
Regeneron Study Site
Sarasota, Florida, 34239
Regeneron Study Site
Seattle, Washington, 98109
Regeneron Study Site
Seattle, Washington, 98122
Regeneron Study Site
Shreveport, Louisiana, 71118
Regeneron Study Site
Sioux Falls, South Dakota, 57108
Regeneron Study Site
St. Petersburg, Florida, 33705
Regeneron Study Site
Stanford, California, 94305
Regeneron Study Site
Tampa, Florida, 33606
Regeneron Study Site
Teaneck, New Jersey, 07666
Regeneron Study Site
The Bronx, New York, 10451
Regeneron Study Site
The Bronx, New York, 10461
Regeneron Study Site
Tucson, Arizona, 85712
Regeneron Study Site
Tucson, Arizona, 85724
Regeneron Study Site
Tyler, Texas, 75708
Regeneron Study Site
Washington D.C., District of Columbia, 20037
Regeneron Study Site
West Palm Beach, Florida, 33407
Regeneron Study Site
Wilmington, North Carolina, 28401
Regeneron Study Site
Winter Haven, Florida, 33880
Regeneron Study Site
Winter Park, Florida, 32789
Mexico11 sites
Regeneron Study Site
Chihuahua City, 31238
Regeneron Study Site
Durango, 34000
Regeneron Study Site
Guadalajara, Jalisco, 44280
Regeneron Study Site
Guadalajara, Jalisco, 44340
Regeneron Study Site
Mérida, Yucatán, 97070
Regeneron Study Site
Mérida, 97000
Regeneron Study Site
Mexico City, 3100
Regeneron Study Site
Monterrey, Nuevo León, 64710
Regeneron Study Site
Monterrey, Nuevo León, 64718
Regeneron Study Site
Veracruz, 91900
Regeneron Study Site
Zapopan, Jalisco, 45070
About this study
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
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
Read more
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
- Conditions
- COVID-19
- Being tested
- casirivimab+imdevimab combination therapy
- Keywords
- Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
casirivimab+imdevimab combination therapyDrug
Also called REGN-COV2, REGN10933, REGN10987, REGEN-COV™
Administered intravenously (IV) single dose
| Study group | Role | What they receive |
|---|---|---|
| casirivimab+imdevimab low dose | Experimental | Low dose or body-weight equivalent for those under 18 years of age. Receives: Drug: casirivimab+imdevimab combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3]
Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
Measured: Through Day 29
Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
Measured: Through Day 4
Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
Measured: Through Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2)
Primary:
Phase 1, Phase 2
Measured: Baseline up to Day 7
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo)
Primary:
Phase 3 (Cohort 1)
Measured: Through Day 29
Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2)
Phase 3 Cohort 2
[Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]
Measured: Up to Nominal Sampling Day 28
Secondary outcomes (84)
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo)
Phase 3 Cohort 1
Measured: Up to Day 29
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo)
Phase 3 (Cohort 1)
Measured: Through Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo)
Phase 3 (Cohort 1)
Measured: Day 4 thru Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 2.4g vs. Placebo)
Phase 3 (Cohort 1)
Measured: From Day 4 Through Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort)
Next Phase 2 Symptomatic
Measured: Day 5, Day 7, Day 15, Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2)
Phase 1, Phase 2
Measured: Day 1 to Day 29
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit Through Day 29 (Ph1, Ph2)
Phase 1, Phase 2
Measured: Through Day 29
Percentage of Participants With ≥1 COVID-19 Related Hospitalization, Emergency Room, or Urgent Care Visit Through Day 29 (Ph1, Ph2)
Phase 1, Phase 2
Measured: Through Day 29
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
Phase 2 Only
Measured: Up to Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV
Phase 3 Cohort 1 - Placebo vs. 1.2 g IV
Measured: Through Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV
Phase 3 (Cohort 1)
Measured: Through day 29
Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3)
Secondary:
Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 3) - Symptomatic Participants
[Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]
Measured: Up to Nominal Sampling Day 28
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1)
Phase 1 Only
Measured: Through Day 29
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1)
Phase 1 Only
Measured: Through Day 29
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1)
Phase 1 Only
Measured: Through Day 29
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants
Measured: Through Day 29
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph3 Cohort 2 - Cohort 3)
Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants
Measured: Through Day 29
Immunogenicity as Measured by ADA to REGN10987 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants
Measured: Through Day 29
Immunogenicity as Measured by ADA to REGN10987 (Ph3 Cohort 2 and Cohort 3)
Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants
Measured: Through Day 29
Immunogenicity as Measured by Neutralizing Antibodies (NAbs) to REGN10933 (Ph3 Cohort 2, Ph3 Cohort 3)
Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants
(TE\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Measured: Through Day 29
Immunogenicity as Measured by NAbs to REGN10987 (Ph3 Cohort 2 - Cohort 3)
Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants
(TE\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Measured: Through Day 29
Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Measured: Through Day 29
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2)
Phase 1, Phase 2 Medically-attended Visits include Hospitalizations, ER visits, Urgent Care Clinic visits, Outpatient/physician office/telemedicine visits
Measured: Through Day 29
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV
Phase 3 (Cohort 1)
Measured: Through Day 29
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV
Phase 3 Cohort 1
Measured: Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2)
Phase 1 and Phase 2
Measured: Through Day 29
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only)
Phase 1 Only
Measured: Through Day 29
Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only)
Phase 1 Only
Measured: Though Day 29
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only)
Phase 1 Only
Measured: Through Day 29
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)
Phase 1 Only - Tlast (Time of last quantifiable concentration)
Measured: Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Measured: Day 4 Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Measured: Day 4 Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Number of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Measured: Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Measured: Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Measured: Through Day 29
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g
Phase 3 Cohort 1
Measured: by Day 29, Day 120, and Day 169
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g
Phase 3 Cohort 1 Placebo vs. 2.4g IV
Measured: by Day 29, Day 120, and Day 169
Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only)
Next Phase 2 Only
Measured: Through Day 29
Correlation of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only)
Phase 1 Only
Measured: Up to Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasal Swabs - (Phase 1 Only)
Phase 1 Only
Measured: Baseline Up To Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Saliva Samples - (Phase 1 Only)
Phase 1 Only
Measured: Baseline Up to Day 29
Concordance of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only)
Phase 1 Only
Measured: Up To Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by RT-qPCR in Saliva Samples - (Phase 1)
Phase 1 Only
Measured: Baseline up to Day 22
Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only)
Phase 2 Only
Measured: Through Day 29
Duration of Symptoms Consistent With COVID-19 (Phase 2 Only)
Phase 2 Only
Measured: Through Day 29
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
Phase 2 Only
Measured: Through Day 29
Number of Participants Admitted to a Hospital Due to COVID-19 (Phase 1, Phase 2)
Phase 1, Phase 2
Measured: Through Day 29
Time to Negative RT-qPCR in All Tested Samples With no Subsequent Positive RT-qPCR in Any Tested Samples - (Phase 1 Only)
Phase 1 Only
Measured: Through Day 29
Proportion of Participants With All-cause Mortality (Phase 2 Asymptomatic)
Phase 2 Asymptomatic
Measured: Through Day 29
Time to All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1 (1.2g IV)
Measured: Through Day 169
Time to All-cause Death (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1 (2.4g IV)
Measured: Through Day 169
Time to All-cause Death (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Measured: Through Day 29
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 1.2g vs Placebo)
Measured: Through Day 29
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 2.4g vs Placebo)
Measured: Through Day 29
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Measured: Through Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo)
Phase 3 Cohort 1
Measured: Baseline up to Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo)
Phase 3 Cohort 1
Measured: Baseline up to Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2)
Phase 3 Cohort 2
Measured: Baseline up to Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 1)
Phase 3 (Cohort 1)
Measured: Baseline to Day 7
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 2)
Phase 3 (Cohort 2)
Measured: Baseline to Day 7
Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only)
Next Phase 2 Symptomatic
Measured: Day 0, Day 5, Day 7, Day 15, Day 29
Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only)
Next Phase 2 Symptomatic
Measured: Day 0, Day 5, Day 7, Day 15, Day 29
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 1.2g IV
Phase 3 (Cohort 1)
Measured: Through Day 29
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 2.4g IV
Phase 3 (Cohort 1)
Measured: Through Day 29
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 2)
Phase 3 (Cohort 2)
Measured: Through Day 29
Number of Days of Hospitalization Due to COVID-19 (Phase 2 Asymptomatic)
Phase 2 Only
Measured: Up to Day 29
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 1.2g IV
Phase 3 (Cohort 1)
Measured: Through Day 29
Percentage of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 2.4g IV
Phase 3 (Cohort 1)
Measured: Through Day 29
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 2)
Phase 3 (Cohort 2)
Measured: Through Day 29
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Next Phase 2) #87
Next Phase 2
Measured: Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 1.2g
Phase 3 Cohort 1
Measured: Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 2.4g
Phase 3 Cohort 1
Measured: Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 2)
Phase 3 Cohort 2
Measured: Through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start16 Jun 2020
- Primary completion21 Jan 2022
- Study completion9 Jun 2022
Why it stopped: Emerging SARS-CoV-2 variants impacting susceptibility to study drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1/Phase 2/Phase 3
- Masking
- None (open label)
- Enrolment
- 10,078 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425629
- Sponsor's protocol ID
- R10933-10987-COV-2067
- Other IDs
- 2020-003690-21
- Status last verified
- Dec 2023
- First submitted
- 8 Jun 2020
- Last updated
- 21 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
- Expanded access
- Available
Publications
Norton TD, Thakur M, Ganguly S, Ali S, Chao J, Waldron A, Xiao J, Patel Y, Turner KC, Davis JD, Irvin SC, Pan C, Atmodjo-Watkins D, Hooper AT, Hamilton JD, Subramaniam D, Bocchini JA, Kowal B, DiCioccio AT, Bhore R, Geba GP, Cox E, Braunstein N, Dakin P, Herman GA. Assessing the safety and pharmacokinetics of casirivimab and imdevimab (CAS+IMD) in a cohort of pregnant outpatients with COVID-19: results from an adaptive, multicentre, randomised, double-blind, phase 1/2/3 study. BMJ Open. 2024 Oct 8;14(10):e087431. doi: 10.1136/bmjopen-2024-087431.
PubMed 39384241Rofail D, Hussein M, Naumann U, Podolanczuk AJ, Norton T, Ali S, Mastey V, Ivanescu C, Hirshberg B, Geba GP. Patient-Reported Outcomes in COVID-19 Treatment with Monoclonal Antibodies Reveal Benefits in Return to Usual Activities. Infect Dis Ther. 2024 Aug;13(8):1861-1876. doi: 10.1007/s40121-024-01013-1. Epub 2024 Jul 3.
PubMed 38961047Murayama A. Industry Payments to Pediatricians in the United States Between 2013 and 2021. Clin Pediatr (Phila). 2024 Oct;63(9):1308-1317. doi: 10.1177/00099228231218850. Epub 2023 Dec 15.
PubMed 38102791Bermejo-Gomez A, Aguilera-Alonso D, Rincon-Lopez EM, Catalan-Alonso P, Bardon-Cancho EJ, Garcia-Morin M, Manrique-Rodriguez S, Navarro-Gomez ML. Use of Monoclonal Antibodies in a Pediatric Patient With Severe Combined Immunodeficiency and Persistent SARS-CoV-2 Infection. Pediatr Infect Dis J. 2023 Aug 1;42(8):e290-e292. doi: 10.1097/INF.0000000000003938. Epub 2023 Apr 27.
PubMed 37079569Hirsch 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.
PubMed 35713300Weinreich 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.
PubMed 34587383Kreuzberger 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.
PubMed 34473343Weinreich 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.
PubMed 33332778
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04425629
- Acronym / sponsor ID
- R10933-10987-COV-2067
- Conditions
- COVID-19
- Keywords
- Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Emerging SARS-CoV-2 variants impacting susceptibility to study drug
- Enrolment
- 10,078 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 21 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1/Phase 2/Phase 3
| Arm | Type | Receives |
|---|---|---|
| casirivimab+imdevimab low dose | Experimental | Drug: casirivimab+imdevimab combination therapyLow dose or body-weight equivalent for those under 18 years of age. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| casirivimab+imdevimab combination therapyAlso: REGN-COV2, REGN10933, REGN10987, REGEN-COV™Administered intravenously (IV) single dose | Drug | casirivimab+imdevimab low dose |
Primary outcome
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3]
Time frame: Through Day 29
Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)
Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Time frame: Through Day 4
Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)
Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Time frame: Through Day 29
Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2)
Time frame: Baseline up to Day 7
Primary: Phase 1, Phase 2
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
Time frame: Through Day 29
Phase 3 Cohort 1
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo)
Time frame: Through Day 29
Primary: Phase 3 (Cohort 1)
Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2)
Time frame: Up to Nominal Sampling Day 28
Phase 3 Cohort 2 [Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]
84 secondary outcomes
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo)
Time frame: Up to Day 29
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo)
Time frame: Through Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo)
Time frame: Day 4 thru Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 2.4g vs. Placebo)
Time frame: From Day 4 Through Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort)
Time frame: Day 5, Day 7, Day 15, Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2)
Time frame: Day 1 to Day 29
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit Through Day 29 (Ph1, Ph2)
Time frame: Through Day 29
Percentage of Participants With ≥1 COVID-19 Related Hospitalization, Emergency Room, or Urgent Care Visit Through Day 29 (Ph1, Ph2)
Time frame: Through Day 29
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
Time frame: Up to Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV
Time frame: Through Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV
Time frame: Through day 29
Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3)
Time frame: Up to Nominal Sampling Day 28
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1)
Time frame: Through Day 29
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1)
Time frame: Through Day 29
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1)
Time frame: Through Day 29
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
Time frame: Through Day 29
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph3 Cohort 2 - Cohort 3)
Time frame: Through Day 29
Immunogenicity as Measured by ADA to REGN10987 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
Time frame: Through Day 29
Immunogenicity as Measured by ADA to REGN10987 (Ph3 Cohort 2 and Cohort 3)
Time frame: Through Day 29
Immunogenicity as Measured by Neutralizing Antibodies (NAbs) to REGN10933 (Ph3 Cohort 2, Ph3 Cohort 3)
Time frame: Through Day 29
Immunogenicity as Measured by NAbs to REGN10987 (Ph3 Cohort 2 - Cohort 3)
Time frame: Through Day 29
Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2)
Time frame: Through Day 29
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2)
Time frame: Through Day 29
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV
Time frame: Through Day 29
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV
Time frame: Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2)
Time frame: Through Day 29
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only)
Time frame: Through Day 29
Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only)
Time frame: Though Day 29
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only)
Time frame: Through Day 29
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only)
Time frame: Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Time frame: Day 4 Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Time frame: Day 4 Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Time frame: Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Time frame: Through Day 29
Number of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Phase 3 Cohort 2)
Time frame: Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Time frame: Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Time frame: Through Day 29
Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2)
Time frame: Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Time frame: Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Time frame: Through Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39384241Norton TD, Thakur M, Ganguly S, Ali S, Chao J, Waldron A, Xiao J, Patel Y, Turner KC, Davis JD, Irvin SC, Pan C, Atmodjo-Watkins D, Hooper AT, Hamilton JD, Subramaniam D, Bocchini JA, Kowal B, DiCioccio AT, Bhore R, Geba GP, Cox E, Braunstein N, Dakin P, Herman GA. Assessing the safety and pharmacokinetics of casirivimab and imdevimab (CAS+IMD) in a cohort of pregnant outpatients with COVID-19: results from an adaptive, multicentre, randomised, double-blind, phase 1/2/3 study. BMJ Open. 2024 Oct 8;14(10):e087431. doi: 10.1136/bmjopen-2024-087431.
- Derived from this study: PubMed 38961047Rofail D, Hussein M, Naumann U, Podolanczuk AJ, Norton T, Ali S, Mastey V, Ivanescu C, Hirshberg B, Geba GP. Patient-Reported Outcomes in COVID-19 Treatment with Monoclonal Antibodies Reveal Benefits in Return to Usual Activities. Infect Dis Ther. 2024 Aug;13(8):1861-1876. doi: 10.1007/s40121-024-01013-1. Epub 2024 Jul 3.
- Derived from this study: PubMed 38102791Murayama A. Industry Payments to Pediatricians in the United States Between 2013 and 2021. Clin Pediatr (Phila). 2024 Oct;63(9):1308-1317. doi: 10.1177/00099228231218850. Epub 2023 Dec 15.
- Derived from this study: PubMed 37079569Bermejo-Gomez A, Aguilera-Alonso D, Rincon-Lopez EM, Catalan-Alonso P, Bardon-Cancho EJ, Garcia-Morin M, Manrique-Rodriguez S, Navarro-Gomez ML. Use of Monoclonal Antibodies in a Pediatric Patient With Severe Combined Immunodeficiency and Persistent SARS-CoV-2 Infection. Pediatr Infect Dis J. 2023 Aug 1;42(8):e290-e292. doi: 10.1097/INF.0000000000003938. Epub 2023 Apr 27.
- Derived from this study: PubMed 35713300Hirsch 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.
- Derived from this study: PubMed 34587383Weinreich 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.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Derived from this study: PubMed 33332778Weinreich 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.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
114 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing casirivimab+imdevimab combination therapy in people with COVID-19, run by Regeneron Pharmaceuticals at 114 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 114 sites in United States, Mexico, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] (time frame: Through Day 29). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04425629, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.