COVID-19Phase 2NCT04666441

COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection

A Phase 2 study testing REGN10933+REGN10987 combination therapy in people with COVID-19, run by Regeneron Pharmaceuticals at 57 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: REGN10933+REGN10987 combination therapy
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,149 participants
Where: 57 sitesUnited States
Study dates: 15 Dec 2020to 21 Sep 2021
Phase: Phase 2
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 18 years and older
All sexes
No healthy volunteers
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, 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

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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

Who cannot join

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, (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)

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Prior use (prior to randomization), current use (at randomization), or planned use (within time period given per CDC guidance but no sooner than 22 days of study drug administration) of any authorized or approved vaccine for COVID-19
Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test
Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19
NOTE: Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

57 sites in 1 country.

City, postcode or hospital

57 sites in 1 country

United States57 sites

Regeneron Study Site
Amarillo, Texas, 79109
Regeneron Study Site
Ames, Iowa, 50010-3014
Regeneron Study Site
Atlanta, Georgia, 30322
Regeneron Study Site
Baltimore, Maryland, 21201
Regeneron Study Site
Canoga Park, California, 91303
Regeneron Study Site
Charleston, South Carolina, 29425
Regeneron Study Site
Charlotte, North Carolina, 28209
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
Dayton, Ohio, 45409
Regeneron Study Site
Dayton, Ohio, 45432
Regeneron Study Site
DeLand, Florida, 32720
Regeneron Study Site
Downers Grove, Illinois, 60515
Regeneron Study Site
Durham, North Carolina, 27705
Regeneron Study Site
Falls Church, Virginia, 22042
Regeneron Study Site
Ft. Pierce, Florida, 34982
Regeneron Study Site
Hialeah, Florida, 33010
Regeneron Study Site
Hialeah, Florida, 33012
Regeneron Study Site
Houston, Texas, 77008
Regeneron Study Site
Houston, Texas, 77030
Regeneron Study Site
Houston, Texas, 77057
Regeneron Study Site
Houston, Texas, 77093
Regeneron Study Site
Iowa City, Iowa, 52242
Regeneron Study Site
Lake Charles, Louisiana, 70601
Regeneron Study Site
Las Vegas, Nevada, 89109
Regeneron Study Site
Long Beach, California, 90806
Regeneron Study Site
Los Angeles, California, 90036
Regeneron Study Site
Maitland, Florida, 32751
Regeneron Study Site
Marrero, Louisiana, 70072
Regeneron Study Site
Mesa, Arizona, 85210
Regeneron Study Site
Miami, Florida, 33126
Regeneron Study Site
Miami, Florida, 33184
Regeneron Study Site
New York, New York, 10037
Regeneron Study Site
Pearland, Texas, 77584
Regeneron Study Site
Philadelphia, Pennsylvania, 19140
Regeneron Study Site
Red Oak, Texas, 75154
Regeneron Study Site
Rolling Hills Estates, California, 90274
Regeneron Study Site
San Antonio, Texas, 78249
Regeneron Study Site
San Francisco, California, 94127
Regeneron Study Site
Santa Monica, California, 90404
Regeneron Study Site
Shreveport, Louisiana, 71118
Regeneron Study Site
Splendora, Texas, 77372
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
Tucson, Arizona, 85712
Regeneron Study Site
Tyler, Texas, 75701
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

Other trials in United States

About this study

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

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
To assess the immunogenicity of REGN10933 and REGN10987

Conditions: COVID-19
Being tested: REGN10933+REGN10987 combination therapy, Placebo
Keywords: Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus, Non-hospitalized
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.

REGN10933+REGN10987 combination therapyDrug
Also called REGN-COV2, REGEN-COV™, Ronapreve™, casirivimab
Administered IV or SC single dose
PlaceboDrug
Administered IV or SC single dose to match

Study groups in NCT04666441
Study group	Role	What they receive
IV Dose 1	Experimental	Combination therapy intravenous (IV) single dose Receives: Drug: REGN10933+REGN10987 combination therapy
IV Dose 2	Experimental	Combination therapy IV single dose Receives: Drug: REGN10933+REGN10987 combination therapy
IV Dose 3	Experimental	Combination therapy IV single dose Receives: Drug: REGN10933+REGN10987 combination therapy
IV Dose 4	Experimental	Combination therapy IV single dose Receives: Drug: REGN10933+REGN10987 combination therapy
Placebo IV Dose	Experimental	Matching placebo IV single dose Receives: Drug: Placebo
SC Dose 1	Experimental	Combination therapy subcutaneous (SC) single dose Receives: Drug: REGN10933+REGN10987 combination therapy
SC Dose 2	Experimental	Combination therapy SC single dose Receives: Drug: REGN10933+REGN10987 combination therapy
Placebo SC Dose	Experimental	Matching placebo SC single dose Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Measured: Day 1 to Day 7

Secondary outcomes (17)

Time-Weighted Average Daily Change From Day 1 in Viral Load
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Measured: Day 1 to Day 5
Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline.
Measured: Day 1 to Day 7
Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline.
Measured: Day 1 to Day 5
Number of Participants With High Viral Load
Number of participants with viral load greater than 10,000 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Measured: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Number of Participants With Viral Loads Below the Limit of Detection
Number of participants with viral load less than 299 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Measured: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Number of Participants With Viral Loads Below the Lower Limit of Quantification
Number of participants with viral load less than 714 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Measured: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples
Change from Day 1 in Viral Load (log10 copies/mL) as Measured by Quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) Swab Samples
Measured: Day 3, Day 5, Day 7, Day 15, Day 22
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Measured: Through day 29
Number of Participants With Infusion-Related Reactions Grade 2 or Above
Measured: Through day 4
Number of Participants With Injection-Site Reactions Grade 3 or Above
Measured: Through day 4
Number of Participants With Hypersensitivity Reactions Grade 2 or Above
Measured: Through day 29
Concentration of REGN10933 in Serum
Measured: Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
Measured: Through day 120
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933
Measured: Through day 120
Concentration of REGN10987 in Serum
Measured: Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
Measured: Through day 120
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987
Measured: Through day 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202021 Sep 2021

First posted14 Dec 2020
Study start15 Dec 2020
Primary completion4 Mar 2021
Study completion21 Sep 2021

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 (3)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04666441
Sponsor's protocol ID: R10933-10987-COV-20145
Status last verified: Mar 2022
First submitted: 10 Dec 2020
Last updated: 8 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

Publications

Portal-Celhay C, Forleo-Neto E, Eagan W, Musser BJ, Davis JD, Turner KC, Norton T, Hooper AT, Hamilton JD, Pan C, Mahmood A, Baum A, Kyratsous CA, Kim Y, Parrino J, Kampman W, Roque-Guerrero L, Stoici R, Fatakia A, Soo Y, Geba GP, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman GA, Yancopoulos GD, Weinreich DM; COVID-19 Phase 2 Dose-Ranging Study Team. Virologic Efficacy of Casirivimab and Imdevimab COVID-19 Antibody Combination in Outpatients With SARS-CoV-2 Infection: A Phase 2 Dose-Ranging Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225411. doi: 10.1001/jamanetworkopen.2022.25411.
PubMed 35969402
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
PubMed 35713300
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04666441
Acronym / sponsor ID: R10933-10987-COV-20145
Conditions: COVID-19
Keywords: Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus, Non-hospitalized
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,149 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 15 Dec 2020 (actual)
Primary completion: 4 Mar 2021 (actual)
Study completion: 21 Sep 2021 (actual)
First posted: 14 Dec 2020 (actual)
Results: Posted 8 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
To assess the immunogenicity of REGN10933 and REGN10987

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
IV Dose 1	Experimental	Drug: REGN10933+REGN10987 combination therapyCombination therapy intravenous (IV) single dose
IV Dose 2	Experimental	Drug: REGN10933+REGN10987 combination therapyCombination therapy IV single dose
IV Dose 3	Experimental	Drug: REGN10933+REGN10987 combination therapyCombination therapy IV single dose
IV Dose 4	Experimental	Drug: REGN10933+REGN10987 combination therapyCombination therapy IV single dose
Placebo IV Dose	Experimental	Drug: PlaceboMatching placebo IV single dose
SC Dose 1	Experimental	Drug: REGN10933+REGN10987 combination therapyCombination therapy subcutaneous (SC) single dose
SC Dose 2	Experimental	Drug: REGN10933+REGN10987 combination therapyCombination therapy SC single dose
Placebo SC Dose	Experimental	Drug: PlaceboMatching placebo SC single dose

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Has SARS-CoV-2-positive diagnostic test from a sample collected ≤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:
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 (10 listed)

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

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
REGN10933+REGN10987 combination therapyAlso: REGN-COV2, REGEN-COV™, Ronapreve™, casirivimabAdministered IV or SC single dose	Drug	IV Dose 1, IV Dose 2, IV Dose 3, IV Dose 4, SC Dose 1, SC Dose 2
PlaceboAdministered IV or SC single dose to match	Drug	Placebo IV Dose, Placebo SC Dose

Primary outcome

Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples
Time frame: Day 1 to Day 7
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

17 secondary outcomes

Time-Weighted Average Daily Change From Day 1 in Viral Load
Time frame: Day 1 to Day 5
Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline
Time frame: Day 1 to Day 7
Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline
Time frame: Day 1 to Day 5
Number of Participants With High Viral Load
Time frame: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Number of Participants With Viral Loads Below the Limit of Detection
Time frame: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Number of Participants With Viral Loads Below the Lower Limit of Quantification
Time frame: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples
Time frame: Day 3, Day 5, Day 7, Day 15, Day 22
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Time frame: Through day 29
Number of Participants With Infusion-Related Reactions Grade 2 or Above
Time frame: Through day 4
Number of Participants With Injection-Site Reactions Grade 3 or Above
Time frame: Through day 4
Number of Participants With Hypersensitivity Reactions Grade 2 or Above
Time frame: Through day 29
Concentration of REGN10933 in Serum
Time frame: Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
Time frame: Through day 120
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933
Time frame: Through day 120
Concentration of REGN10987 in Serum
Time frame: Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
Time frame: Through day 120
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987
Time frame: Through day 120

Results and safety

Results posted to the registry on 8 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo IV Dose	82	80
300mg IV	165	160
600mg IV	162	158
1200mg IV	165	161
2400mg IV	166	166
Placebo SC Dose	82	79
600mg SC	163	158
1200mg SC	164	160

Primary outcome: Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples

Time frame: Day 1 to Day 7. Least squares mean (Standard Error). Unit: log10 copies/mL

Measure	Pooled Placebo (IV + SC) n = 74	300mg IV n = 76	600mg IV n = 66	1200mg IV n = 67	2400mg IV n = 61	600mg SC n = 71	1200mg SC n = 71
Value	-1.68 (0.11)	-2.25 (0.11)	-2.34 (0.12)	-2.24 (0.12)	-2.40 (0.12)	-2.24 (0.12)	-2.24 (0.12)

Pooled Placebo (IV + SC) vs 300mg IV: Difference of LS Means: -0.57 (95% CI -0.88 to -0.25), p = 0.0004, ANCOVA
Pooled Placebo (IV + SC) vs 600mg IV: Difference of LS Means: -0.66 (95% CI -0.99 to -0.34), p <0.0001, ANCOVA
Pooled Placebo (IV + SC) vs 1200mg IV: Difference of LS Means: -0.56 (95% CI -0.89 to -0.24), p = 0.0007, ANCOVA

Population analysed: Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug to Day 169. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo IV	1 of 82 (1.2%)	17 of 82 (20.7%)	0 of 82
REGN10933 + REGN10987 300 mg IV	1 of 165 (0.6%)	21 of 165 (12.7%)	0 of 165
REGN10933 + REGN10987 600 mg IV	0 of 162 (0%)	27 of 162 (16.7%)	0 of 162
REGN10933 + REGN10987 1200 mg IV	1 of 165 (0.6%)	28 of 165 (17%)	0 of 165
REGN10933 + REGN10987 2400 mg IV	3 of 166 (1.8%)	16 of 166 (9.6%)	0 of 166
Placebo SC	0 of 82 (0%)	11 of 82 (13.4%)	0 of 82
REGN10933 + REGN10987 600 mg SC	0 of 163 (0%)	18 of 163 (11%)	0 of 163
REGN10933 + REGN10987 1200 mg SC	1 of 164 (0.6%)	21 of 164 (12.8%)	0 of 164

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35969402Portal-Celhay C, Forleo-Neto E, Eagan W, Musser BJ, Davis JD, Turner KC, Norton T, Hooper AT, Hamilton JD, Pan C, Mahmood A, Baum A, Kyratsous CA, Kim Y, Parrino J, Kampman W, Roque-Guerrero L, Stoici R, Fatakia A, Soo Y, Geba GP, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman GA, Yancopoulos GD, Weinreich DM; COVID-19 Phase 2 Dose-Ranging Study Team. Virologic Efficacy of Casirivimab and Imdevimab COVID-19 Antibody Combination in Outpatients With SARS-CoV-2 Infection: A Phase 2 Dose-Ranging Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225411. doi: 10.1001/jamanetworkopen.2022.25411.
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 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.
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

57 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REGN10933+REGN10987 combination therapy in people with COVID-19, run by Regeneron Pharmaceuticals at 57 sites in United States.

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 12 inclusion and 10 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: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Apr 2022). 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?

Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples (time frame: Day 1 to Day 7). 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 NCT04666441, which also lists 3 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 8 Apr 2022.