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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

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

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


Condition or disease Intervention/treatment Phase
COVID-19 Drug: REGN10933+REGN10987 combination therapy Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2104 participants
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
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
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : December 19, 2020
Estimated Study Completion Date : December 19, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: REGN10933+REGN10987 low dose Drug: REGN10933+REGN10987 combination therapy
Administered intravenously (IV) single dose

Experimental: REGN10933+REGN10987 high dose Drug: REGN10933+REGN10987 combination therapy
Administered intravenously (IV) single dose

Placebo Comparator: Placebo Drug: Placebo
Placebo IV Single Dose




Primary Outcome Measures :
  1. Proportion of patients with treatment-emergent serious adverse events (SAEs) [ Time Frame: Through Day 29 ]

    Primary:

    Phase 1

    Secondary:

    Phase 2, Phase 3


  2. Proportion of patients with infusion-related reactions [ Time Frame: Through Day 4 ]

    Primary:

    Phase 1

    Secondary:

    Phase 2, Phase 3


  3. Proportion of patients with hypersensitivity reactions [ Time Frame: Through Day 29 ]

    Primary:

    Phase 1

    Secondary:

    Phase 2, Phase 3


  4. 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


  5. 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



Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Time to negative RT-qPCR in NP swabs with no subsequent positive RT-qPCR [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3

  5. Change from baseline in viral shedding as measured by RT-qPCR in NP swabs [ Time Frame: Baseline up to Day 29 ]
  6. Change from baseline in viral shedding as measured by RT-qPCR in saliva samples [ Time Frame: Baseline up to Day 29 ]
    Phase 1 Only

  7. Change from baseline in viral shedding as measured by RT-qPCR in nasal swabs [ Time Frame: Baseline up to Day 29 ]
    Phase 1 Only

  8. Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva) [ Time Frame: Up to Day 29 ]
    Phase 1 Only

  9. Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva) [ Time Frame: Up to Day 29 ]
    Phase 1 Only

  10. Time-weighted average change from baseline in viral shedding [ Time Frame: Baseline up to Day 29 ]
  11. Proportion of patients with at least two COVID-19 related medically attended visits [ Time Frame: Through Day 29 ]
    Phase 1 Phase 2

  12. Total number of COVID-19 related medically-attended visits [ Time Frame: Through Day 29 ]
  13. Proportion of patients admitted to a hospital due to COVID-19 [ Time Frame: Through Day 29 ]
  14. Proportion of patients admitted to an intensive care unit (ICU) due to COVID-19 [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3

  15. Proportion of patients at least 1 outpatient or telemedicine visit due to COVID-19 [ Time Frame: Through Day 29 ]
  16. Proportion of patients requiring mechanical ventilation due to COVID-19 [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3

  17. Number of days of hospitalization due to COVID-19 [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3

  18. Number of deaths due to any cause (All-Cause Mortality) [ Time Frame: Through Day 29 ]
    Phase 2, Phase 3

  19. Time to first onset of symptoms consistent with COVID-19 (asymptomatic cohort only) [ Time Frame: Up to Day 29 ]
    Phase 2

  20. Duration of symptoms consistent with COVID-19 [ Time Frame: Up to Day 29 ]
    Phase 2

  21. Serum concentration of REGN10933 over time [ Time Frame: Through Day 29 ]
  22. Serum concentration of REGN10987 over time [ Time Frame: Through Day 29 ]
  23. Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only

  24. Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only

  25. Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only

  26. Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only

  27. Assessment of PK parameter: Time to Cmax (tmax) for REGN10933 [ Time Frame: Through Day 29 ]
    Phase 1 only

  28. Assessment of PK parameter: Time to Cmax (tmax) for REGN10987 [ Time Frame: Through Day 29 ]
    Phase 1 only

  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 [ Time Frame: Through Day 29 ]
    Phase 1 only

  30. 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

  31. Incidence of anti-drug antibodies (ADA) to REGN10933 [ Time Frame: Through Day 29 ]
  32. Incidence of anti-drug antibodies (ADA) to REGN10987 [ Time Frame: Through Day 29 ]


Information from the National Library of Medicine

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.


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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 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


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): NCT04425629


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04425629    
Other Study ID Numbers: R10933-10987-COV-2067
2020-003690-21 ( EudraCT Number )
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
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: 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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
coronavirus