COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection
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| ClinicalTrials.gov Identifier: NCT04666441 |
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Recruitment Status :
Completed
First Posted : December 14, 2020
Results First Posted : April 8, 2022
Last Update Posted : April 8, 2022
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Sponsor:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
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Brief 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 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: REGN10933+REGN10987 combination therapy Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1149 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 |
| Actual Primary Completion Date : | March 4, 2021 |
| Actual Study Completion Date : | September 21, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Arm | Intervention/treatment |
|---|---|
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Experimental: IV Dose 1
Combination therapy intravenous (IV) single dose
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Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
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Experimental: IV Dose 2
Combination therapy IV single dose
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Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
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Experimental: IV Dose 3
Combination therapy IV single dose
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Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
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Experimental: IV Dose 4
Combination therapy IV single dose
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Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
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Experimental: Placebo IV Dose
Matching placebo IV single dose
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Drug: Placebo
Administered IV or SC single dose to match |
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Experimental: SC Dose 1
Combination therapy subcutaneous (SC) single dose
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Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
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Experimental: SC Dose 2
Combination therapy SC single dose
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Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
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Experimental: Placebo SC Dose
Matching placebo SC single dose
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Drug: Placebo
Administered IV or SC single dose to match |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
- 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 (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.
- 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 ]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.
- 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 load greater than 10,000 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
- 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 load less than 299 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
- 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 ]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.
- 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 ]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
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Has SARS-CoV-2-positive diagnostic test from a sample collected ≤72 hours prior to randomization, as defined by the protocol
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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, (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 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
Information from the National Library of Medicine
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
Locations
Show 57 study locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
Study Documents (Full-Text)
Documents provided by Regeneron Pharmaceuticals:
Documents provided by Regeneron Pharmaceuticals:
Study Protocol [PDF] March 2, 2021
Statistical Analysis Plan [PDF] March 2, 2021
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04666441 |
| Other Study ID Numbers: |
R10933-10987-COV-20145 |
| First Posted: | December 14, 2020 Key Record Dates |
| Results First Posted: | April 8, 2022 |
| Last Update Posted: | April 8, 2022 |
| Last Verified: | March 2022 |
| 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 |
Keywords provided by Regeneron Pharmaceuticals:
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Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus Non-hospitalized |
Additional relevant MeSH terms:
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COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |