COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04425629

Clinical Trials Administrator - Regeneron Pharmaceuticals

clinicaltrials@regeneron.com

2020-06-11

Terminated

RCT

Randomized

Single group assignment

Open label

multi-center

Treatment

key inclusion criteria: - 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

- 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

3

Regeneron Pharmaceuticals

2

100

Mexico;Romania;United States

Mild disease at enrollment

1: Mild disease at enrollment

10078

Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2);Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3);Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3);Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3];Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo);Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo);Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2)

None

Phase 3

[{"arm_notes": "", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]