Status:
TERMINATED
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
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
COVID-19
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- Maintains O2 saturation ≥93% on room air
- Is able to understand and complete study-related questionnaires (patients aged ≥12 years only)
- Key
Exclusion
- 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 COVID-19
- Has participated, is participating or plans to participate in a clinical research study evaluation any authorized, approved or investigational vaccine for COVID-19
- NOTE: Other Protocol defined Inclusion/Exclusion criteria apply
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2022
Estimated Enrollment :
10078 Patients enrolled
Trial Details
Trial ID
NCT04425629
Start Date
June 16 2020
End Date
June 9 2022
Last Update
December 21 2023
Active Locations (114)
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1
Regeneron Study Site
Mesa, Arizona, United States, 85210
2
Regeneron Study Site
Tucson, Arizona, United States, 85712
3
Regeneron Study Site
Tucson, Arizona, United States, 85724
4
Regeneron Study Site
Canoga Park, California, United States, 91303