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

  • STATUS
    Recruiting
  • days left to enroll
    21
  • participants needed
    2104
  • sponsor
    Regeneron Pharmaceuticals
Updated on 18 November 2020
Investigator
Clinical Trials Administrator
Primary Contact
Regeneron Study Site (9.6 mi away) Contact
+81 other location
covid-19
SARS
oropharyngeal
viral shedding
molecular diagnostic

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

Details
Treatment Placebo, REGN10933+REGN10987 combination therapy
Clinical Study IdentifierNCT04425629
SponsorRegeneron Pharmaceuticals
Last Modified on18 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Covid-19 or *COVID-19?
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
Symptomatic Cohort (All Phases): Has symptoms consistent with COVID-19, as determined by the investigator, with onset 7 days before randomization or
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

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
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