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

  • STATUS
    Recruiting
  • End date
    Aug 28, 2021
  • participants needed
    6420
  • sponsor
    Regeneron Pharmaceuticals
Updated on 18 January 2021
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

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 load of SARS-CoV-2

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

Phase 3

  • Cohort 1 (18 Years Old, Not Pregnant at Randomization)

To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, using the composite measure of COVID-19-related medically-attended visit or all-cause death

  • Cohort 2 (<18 Years Old, Not Pregnant at Randomization)
  • To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
  • To further characterize the concentrations of REGN10933 and REGN10987 in serum over time
  • To assess the immunogenicity of REGN10933 and REGN10987
  • Cohort 3 (Pregnant at Randomization)
  • To evaluate the safety and tolerability of REGN10933+REGN10987
  • To characterize the concentrations of REGN10933 and REGN10987 in serum over time
  • To assess the immunogenicity of REGN10933 and REGN10987

Details
Treatment Placebo, REGN10933+REGN10987 combination therapy
Clinical Study IdentifierNCT04425629
SponsorRegeneron Pharmaceuticals
Last Modified on18 January 2021

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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?
Do you have any of these conditions: *COVID-19 or Covid-19?
Do you have any of these conditions: *COVID-19 or Covid-19?
Do you have any of these conditions: *COVID-19 or Covid-19?
Do you have any of these conditions: Covid-19 or *COVID-19?
Do you have any of these conditions: Covid-19 or *COVID-19?
Has SARS-CoV-2-positive diagnostic test (from a sample collected 72 hours prior to randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or saliva)
Has symptoms consistent with COVID-19, as determined by the investigator, with onset 7 days before randomization
Is able to understand and complete study-related questionnaires (patients aged 12 years only)
Maintains O2 saturation 93% on room air

Exclusion Criteria

Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), 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 90 days of study drug administration or per current CDC recommendations, as applicable) of any authorized or approved vaccine for SARS-CoV-2
Has participated, is participating or plans to participate in a clinical research study evaluation any authorized, approved or investigational vaccine for SARS-CoV-2
NOTE: Other Protocol defined Inclusion/Exclusion criteria apply
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