Status:
COMPLETED
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) * To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 * T...
Eligibility Criteria
Inclusion
- Key
- 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 category:
- Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
- 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2021
Estimated Enrollment :
2252 Patients enrolled
Trial Details
Trial ID
NCT04426695
Start Date
June 10 2020
End Date
October 22 2021
Last Update
January 27 2023
Active Locations (123)
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1
Regeneron Study Site
Birmingham, Alabama, United States, 35249
2
Regeneron Study Site
Chandler, Arizona, United States, 85224
3
Regeneron Study Site
Phoenix, Arizona, United States, 85006
4
Regeneron Study Site 1
Tucson, Arizona, United States, 85724