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Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04425629
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 8, 2020
First Posted Date  ICMJE June 11, 2020
Last Update Posted Date November 10, 2020
Actual Study Start Date  ICMJE June 16, 2020
Estimated Primary Completion Date December 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
  • Proportion of patients with treatment-emergent serious adverse events (SAEs) [ Time Frame: Through Day 29 ]
    Primary: Phase 1 Secondary: Phase 2, Phase 3
  • Proportion of patients with infusion-related reactions [ Time Frame: Through Day 4 ]
    Primary: Phase 1 Secondary: Phase 2, Phase 3
  • Proportion of patients with hypersensitivity reactions [ Time Frame: Through Day 29 ]
    Primary: Phase 1 Secondary: Phase 2, Phase 3
  • Time-weighted average change from baseline in viral shedding as measured by quantitative reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples [ Time Frame: Baseline up to Day 22 ]
    Primary: Phase 1, Phase 2 Secondary: Phase 3
  • Proportion of patients with at least one COVID-19 related medically attended visit [ Time Frame: Through Day 29 ]
    Primary: Phase 3 Secondary: Phase 1, Phase 2
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2020)
  • Proportion of patients with treatment-emergent serious adverse events (SAEs) [ Time Frame: Through Day 29 ]
    Primary: Phase 1 Secondary: Phase 2, Phase 3
  • Proportion of patients with infusion-related reactions [ Time Frame: Through Day 4 ]
    Primary: Phase 1 Secondary: Phase 2, Phase 3
  • Proportion of patients with hypersensitivity reactions [ Time Frame: Through Day 29 ]
    Primary: Phase 1 Secondary: Phase 2, Phase 3
  • Time-weighted average change from baseline in viral shedding as measured by quantitative reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples [ Time Frame: Baseline up to Day 22 ]
    Phase 1 only
  • Time-weighted average change from baseline in viral shedding as measured by RT-qPCR in saliva samples [ Time Frame: Baseline up to Day 22 ]
    Primary: Phase 2 Secondary: Phase 1, Phase 3
  • Proportion of patients with at least one COVID-19 related medically attended visit [ Time Frame: Through Day 29 ]
    Primary: Phase 3 Secondary: Phase 1, Phase 2
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2020)
  • Time-weighted average change from baseline in viral shedding measured by RT-qPCR in saliva samples [ Time Frame: Baseline up to Day 22 ]
    Phase 1 Only
  • Time-weighted average change from baseline in viral shedding measured by RT-qPCR in nasal swab samples [ Time Frame: Baseline up to Day 22 ]
    Phase 1 Only
  • Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples [ Time Frame: Through Day 29 ]
    Phase 1 Only
  • Time to negative RT-qPCR in NP swabs with no subsequent positive RT-qPCR [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3
  • Change from baseline in viral shedding as measured by RT-qPCR in NP swabs [ Time Frame: Baseline up to Day 29 ]
  • Change from baseline in viral shedding as measured by RT-qPCR in saliva samples [ Time Frame: Baseline up to Day 29 ]
    Phase 1 Only
  • Change from baseline in viral shedding as measured by RT-qPCR in nasal swabs [ Time Frame: Baseline up to Day 29 ]
    Phase 1 Only
  • Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva) [ Time Frame: Up to Day 29 ]
    Phase 1 Only
  • Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva) [ Time Frame: Up to Day 29 ]
    Phase 1 Only
  • Time-weighted average change from baseline in viral shedding [ Time Frame: Baseline up to Day 29 ]
  • Proportion of patients with at least two COVID-19 related medically attended visits [ Time Frame: Through Day 29 ]
    Phase 1 Phase 2
  • Total number of COVID-19 related medically-attended visits [ Time Frame: Through Day 29 ]
  • Proportion of patients admitted to a hospital due to COVID-19 [ Time Frame: Through Day 29 ]
  • Proportion of patients admitted to an intensive care unit (ICU) due to COVID-19 [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3
  • Proportion of patients at least 1 outpatient or telemedicine visit due to COVID-19 [ Time Frame: Through Day 29 ]
  • Proportion of patients requiring mechanical ventilation due to COVID-19 [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3
  • Number of days of hospitalization due to COVID-19 [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3
  • Number of deaths due to any cause (All-Cause Mortality) [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3
  • Time to first onset of symptoms consistent with COVID-19 (asymptomatic cohort only) [ Time Frame: Up to Day 29 ]
    Phase 2
  • Duration of symptoms consistent with COVID-19 [ Time Frame: Up to Day 29 ]
    Phase 2
  • Serum concentration of REGN10933 over time [ Time Frame: Through Day 29 ]
  • Serum concentration of REGN10987 over time [ Time Frame: Through Day 29 ]
  • Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: Time to Cmax (tmax) for REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: Time to Cmax (tmax) for REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Incidence of anti-drug antibodies (ADA) to REGN10933 [ Time Frame: Through Day 29 ]
  • Incidence of anti-drug antibodies (ADA) to REGN10987 [ Time Frame: Through Day 29 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2020)
  • Time-weighted average change from baseline in viral shedding measured by RT-qPCR in nasal swab samples [ Time Frame: Baseline up to Day 22 ]
  • Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples [ Time Frame: Through Day 29 ]
  • Change from baseline in Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral shedding as measured by RT-qPCR in NP swabs [ Time Frame: Baseline up to Day 29 ]
    Phase 1 only
  • Change from baseline in SARS-CoV-2 viral shedding as measured by RT-qPCR in saliva samples [ Time Frame: Baseline up to Day 29 ]
  • Change from baseline in SARS-CoV-2 viral shedding as measured by RT-qPCR in nasal swabs [ Time Frame: Baseline up to Day 29 ]
  • Proportion of patients with at least two COVID-19 related medically attended visits [ Time Frame: Through Day 29 ]
  • Total number of COVID-19 related medically-attended visits [ Time Frame: Through Day 29 ]
  • Proportion of patients admitted to a hospital due to COVID-19 [ Time Frame: Through Day 29 ]
  • Proportion of patients admitted to an intensive care unit (ICU) due to COVID-19 [ Time Frame: Through Day 29 ]
  • Proportion of patients at least 1 outpatient or telemedicine visit due to COVID-19 [ Time Frame: Through Day 29 ]
  • Proportion of patients requiring mechanical ventilation due to COVID-19 [ Time Frame: Through Day 29 ]
  • Serum concentration of REGN10933 over time [ Time Frame: Through Day 29 ]
  • Serum concentration of REGN10987 over time [ Time Frame: Through Day 29 ]
  • Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: Time to Cmax (tmax) for REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: Time to Cmax (tmax) for REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only
  • Incidence of anti-drug antibodies (ADA) to REGN10933 [ Time Frame: Through Day 29 ]
  • Incidence of anti-drug antibodies (ADA) to REGN10987 [ Time Frame: Through Day 29 ]
  • Number of days of hospitalization due to COVID-19 [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3
  • Number of deaths due to any cause (All-Cause Mortality) [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult Patients With COVID-19
Official Title  ICMJE 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
Brief Summary

The primary objectives are:

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 shedding of SARS-CoV-2

Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral shedding of SARS-CoV-2

Phase 3

• To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Phase 1/Phase 2/Phase 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: REGN10933+REGN10987 combination therapy
    Administered intravenously (IV) single dose
  • Drug: Placebo
    Placebo IV Single Dose
Study Arms  ICMJE
  • Experimental: REGN10933+REGN10987 low dose
    Intervention: Drug: REGN10933+REGN10987 combination therapy
  • Experimental: REGN10933+REGN10987 high dose
    Intervention: Drug: REGN10933+REGN10987 combination therapy
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2020)
2104
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2020)
1054
Estimated Study Completion Date  ICMJE December 19, 2020
Estimated Primary Completion Date December 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable
  • Meets 1 of the following 2 criteria:

    1. Symptomatic Cohort (All Phases): Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization or
    2. Asymptomatic Cohort (Phase 2): Meets all of the following:

      • Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time <2 months prior to randomization
      • Has had no positive SARS-CoV-2 test results from a sample collected >7 days prior to randomization
      • Has had no known contact (of any duration) with an individual who has confirmed COVID-19 or confirmed positive SARS-COV-2 test result >14 days prior to randomization.
  • Has experienced COVID-19 symptoms for <7 days
  • Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤7 days before randomization

Key Exclusion Criteria:

  • Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19
  • Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 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 EUA approved treatments, where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening

NOTE: Other Protocol defined Inclusion/Exclusion criteria apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE Romania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04425629
Other Study ID Numbers  ICMJE R10933-10987-COV-2067
2020-003690-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP