COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04666441 |
Recruitment Status :
Recruiting
First Posted : December 14, 2020
Last Update Posted : January 13, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987 across different intravenous and subcutaneous doses compared to placebo.
The secondary objectives of the study are:
- To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared to placebo
- To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
- To assess the concentrations of REGN10933 and REGN10987 in serum over time
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: REGN10933+REGN10987 combination therapy Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study to Assess the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Outpatients With SARS-CoV-2 Infection |
Actual Study Start Date : | December 15, 2020 |
Estimated Primary Completion Date : | March 1, 2021 |
Estimated Study Completion Date : | April 24, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: IV Dose 1
Combination therapy intravenous (IV) single dose
|
Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
|
Experimental: IV Dose 2
Combination therapy IV single dose
|
Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
|
Experimental: IV Dose 3
Combination therapy IV single dose
|
Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
|
Experimental: IV Dose 4
Combination therapy IV single dose
|
Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
|
Experimental: Placebo IV Dose
Matching placebo IV single dose
|
Drug: Placebo
Administered IV or SC single dose to match |
Experimental: SC Dose 1
Combination therapy subcutaneous (SC) single dose
|
Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
|
Experimental: SC Dose 2
Combination therapy SC single dose
|
Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
|
Experimental: Placebo SC Dose
Matching placebo SC single dose
|
Drug: Placebo
Administered IV or SC single dose to match |
- Time-weighted average daily change from baseline in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples [ Time Frame: Baseline to day 7 ]Measured in patients who have a central-lab determined RT-qPCR positive test and are seronegative at baseline
- Time-weighted average daily change from baseline in viral load (log10 copies/mL) [ Time Frame: Baseline to day 5 ]
- Time-weighted average daily change from baseline in viral load (log10 copies/mL) in patients with high viral load [ Time Frame: Baseline to day 7 ]
- Time-weighted average daily change from baseline in viral load (log10 copies/mL) in patients with high viral load [ Time Frame: Baseline to day 5 ]
- Proportion of patients with high viral load [ Time Frame: At each visit, through day 22 ]
- Proportion of patients with viral loads below the limit of detection [ Time Frame: At each visit, through day 22 ]
- Proportion of patients with viral loads below the lower limit of quantitation [ Time Frame: At each visit, through day 22 ]
- Time-weighted average daily change from baseline in cycle threshold (Ct) as measured by RT-qPCR in NP samples [ Time Frame: Baseline to day 7 ]
- Time-weighted average daily change from baseline in Ct from day 1 to day 5, as measured by RT-qPCR in NP samples [ Time Frame: Baseline to day 5 ]
- Change from baseline in Ct as measured by RT-qPCR in NP samples [ Time Frame: At each visit, Baseline through day 22 ]
- Change from baseline in viral load as measured by RT-qPCR in NP samples [ Time Frame: At each visit, Baseline through day 22 ]
- Proportion of patients with treatment-emergent serious adverse events (SAEs) [ Time Frame: Through day 29 ]
- Proportion of patients with infusion-related reactions (grade ≥2) [ Time Frame: Through day 4 ]
- Proportion of patients with injection-site reactions (grade ≥2) [ Time Frame: Through day 4 ]
- Proportion of patients with hypersensitivity reactions (grade ≥2) [ Time Frame: Through day 29 ]
- Concentrations of REGN10933 in serum [ Time Frame: Through day 22 ]
- Concentrations of REGN10987 in serum [ Time Frame: Through day 22 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Has SARS-CoV-2-positive antigen or molecular diagnostic test ≤72 hours prior to randomization, as defined by the protocol
-
Low-risk symptomatic patient: Has symptoms consistent with COVID-19 (as determined by the investigator) with onset ≤7 days before randomization, and meets all of the following 8 criteria:
- Age ≤50
- No obesity, with obesity defined as BMI ≥30 kg/m2
- Does not have cardiovascular disease or hypertension
- Does not have chronic lung disease or asthma
- Does not have type 1 or type 2 diabetes mellitus
- Does not have chronic kidney disease, with or without dialysis
- Does not have chronic liver disease
- Is not pregnant or
- Asymptomatic patient: Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time <2 months prior to randomization
- Maintains O2 saturation ≥93% on room air
Key Exclusion Criteria:
- Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
- Has a known 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
- Is immunosuppressed, based on investigator's assessment
- 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 planned future use of 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)
- Prior, current, or planned use during the study period of any authorized, approved, or investigational vaccine for COVID-19
- Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test
NOTE: Other protocol defined inclusion/exclusion criteria apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666441
Contact: Clinical Trials Administrator | 844-734-6643 | clinicaltrials@regeneron.com |
United States, Arizona | |
Regeneron Study Site | Recruiting |
Mesa, Arizona, United States, 85210 | |
Regeneron Study Site | Recruiting |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Regeneron Study Site | Recruiting |
Canoga Park, California, United States, 91303 | |
Regeneron Study Site | Recruiting |
Long Beach, California, United States, 90806 | |
Regeneron Study Site | Recruiting |
Los Angeles, California, United States, 90036 | |
Regeneron Study Site | Recruiting |
San Francisco, California, United States, 94127 | |
Regeneron Study Site | Recruiting |
Santa Monica, California, United States, 90404 | |
United States, Colorado | |
Regeneron Study Site | Recruiting |
Colorado Springs, Colorado, United States, 80907 | |
United States, Florida | |
Regeneron Study Site | Recruiting |
DeLand, Florida, United States, 32720 | |
Regeneron Study Site | Recruiting |
Fort Pierce, Florida, United States, 34982 | |
Regeneron Study Site | Recruiting |
Hialeah, Florida, United States, 33010 | |
Regeneron Study Site | Recruiting |
Hialeah, Florida, United States, 33012 | |
Regeneron Study Site | Recruiting |
Maitland, Florida, United States, 32751 | |
Regeneron Study Site | Recruiting |
Miami, Florida, United States, 33126 | |
Regeneron Study Site | Recruiting |
Miami, Florida, United States, 33184 | |
Regeneron Study Site | Recruiting |
Saint Petersburg, Florida, United States, 33705 | |
Regeneron Study Site | Recruiting |
Tampa, Florida, United States, 33606 | |
Regeneron Study Site | Recruiting |
West Palm Beach, Florida, United States, 33407 | |
Regeneron Study Site | Recruiting |
Winter Haven, Florida, United States, 33880 | |
Regeneron Study Site | Recruiting |
Winter Park, Florida, United States, 32789 | |
United States, Georgia | |
Regeneron Study Site | Recruiting |
Columbus, Georgia, United States, 31904 | |
United States, Illinois | |
Regeneron Study Site | Recruiting |
Downers Grove, Illinois, United States, 60515 | |
United States, Iowa | |
Regeneron Study Site | Recruiting |
Ames, Iowa, United States, 50010-3014 | |
United States, Louisiana | |
Regeneron Study Site | Recruiting |
Lake Charles, Louisiana, United States, 70601 | |
Regeneron Study Site | Recruiting |
Marrero, Louisiana, United States, 70072 | |
Regeneron Study Site | Recruiting |
Shreveport, Louisiana, United States, 71118 | |
United States, Maryland | |
Regeneron Study Site | Recruiting |
Baltimore, Maryland, United States, 21201 | |
United States, Nevada | |
Regeneron Study Site | Recruiting |
Las Vegas, Nevada, United States, 89109 | |
United States, New Jersey | |
Regeneron Study Site | Recruiting |
Teaneck, New Jersey, United States, 07666 | |
United States, New York | |
Regeneron Study Site | Recruiting |
Bronx, New York, United States, 10451 | |
United States, North Carolina | |
Regeneron Study Site | Recruiting |
Wilmington, North Carolina, United States, 28401 | |
United States, Ohio | |
Regeneron Study Site | Recruiting |
Columbus, Ohio, United States, 43215 | |
Regeneron Study Site | Recruiting |
Dayton, Ohio, United States, 45409 | |
Regeneron Study Site | Recruiting |
Dayton, Ohio, United States, 45432 | |
United States, South Carolina | |
Regeneron Study Site | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Regeneron Study Site | Recruiting |
Clinton, South Carolina, United States, 29325 | |
United States, Texas | |
Regeneron Study Site | Recruiting |
Amarillo, Texas, United States, 79109 | |
Regeneron Study Site | Recruiting |
Corpus Christi, Texas, United States, 78413 | |
Regeneron Study Site | Recruiting |
Houston, Texas, United States, 77008 | |
Regeneron Study Site | Recruiting |
Houston, Texas, United States, 77030 | |
Regeneron Study Site | Recruiting |
Houston, Texas, United States, 77057 | |
Regeneron Study Site | Recruiting |
Houston, Texas, United States, 77093 | |
Regeneron Study Site | Recruiting |
Pearland, Texas, United States, 77584 | |
Regeneron Study Site | Recruiting |
Red Oak, Texas, United States, 75154 | |
Regeneron Study Site | Recruiting |
San Antonio, Texas, United States, 78249 | |
United States, Virginia | |
Regeneron Study Site | Recruiting |
Falls Church, Virginia, United States, 22042 |
Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
Responsible Party: | Regeneron Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04666441 |
Other Study ID Numbers: |
R10933-10987-COV-20145 |
First Posted: | December 14, 2020 Key Record Dates |
Last Update Posted: | January 13, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy. |
Access Criteria: | Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus Non-hospitalized |
Infection |