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 17 January 2021
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 (Patients 18 Years)

To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by COVID-19-related medically-attended visits

  • Cohort 2 (Patients 0 to <18 Years)
  • To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
  • To characterize further 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 on17 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?
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 is acceptable as long as the sample was collected 72 hours prior to randomization
(Cohort 1): Has symptoms consistent with COVID-19, as determined by the investigator, with onset 7 days before randomization, or
(Cohort 2): Has symptoms consistent with COVID-19, as determined by the investigator, with onset 7 days before randomization, or is asymptomatic at randomization and has no prior symptoms consistent with COVID-19 (as determined by the investigator)
Maintains O2 saturation 93% on room air
Is able to understand and complete study-related questionnaires (cohort 1 and cohort 2 patients aged 12 years only)

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, 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, IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
NOTE: Other Protocol defined Inclusion/Exclusion criteria apply
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