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

  • STATUS
    Recruiting
  • days left to enroll
    82
  • participants needed
    6900
  • sponsor
    Regeneron Pharmaceuticals
Updated on 17 January 2021
Investigator
Clinical Trials Administrator
Primary Contact
Regeneron Study Site (7.6 mi away) Contact
+105 other location
mechanical ventilation
covid-19
SARS
oximetry
oropharyngeal
viral shedding
molecular diagnostic

Summary

The primary objectives are:

Phase 1/2 (Cohort 1)

  • To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
  • To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo Phase 2 (Cohort 1A)
  • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
  • To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo Phase 3 (Cohort 1 and Cohort 1A)
  • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation

Details
Treatment Placebo, REGN10933+REGN10987 combination therapy
Clinical Study IdentifierNCT04426695
SponsorRegeneron Pharmaceuticals
Last Modified on17 January 2021

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Eligibility

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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?
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 and no alternative explanation for current clinical condition. A historical record of positive result from test conducted 72 hours prior to randomization is acceptable
Has symptoms consistent with COVID-19, as determined by investigator, with onset 10 days before randomization
Hospitalized for 72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected
Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
category
Cohort 1: Maintains O2 saturation >93% on low-flow oxygen as defined in the protocol
Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol
Cohort 3: On mechanical ventilation

Exclusion Criteria

Phase 1 Only: Patients maintaining O2 saturation >94% on room air
In the opinion of the investigator, unlikely to survive for >48 hours from screening
Receiving extracorporeal membrane oxygenation (ECMO)
Has new-onset stroke or seizure disorder during hospitalization
Initiated on renal replacement therapy due to COVID-19
NOTE: Other protocol defined inclusion / exclusion criteria apply
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