COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection

COVID-19 Clinical Trial

Official title:

A Phase 2 Study to Assess the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Outpatients With SARS-CoV-2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04666441
• Other study ID #: R10933-10987-COV-20145
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2020
• Est. completion date: September 21, 2021

Study information

• Verified date: March 2022
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987 across different intravenous and subcutaneous doses compared to placebo.

The secondary objectives of the study are:

• To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared to placebo

• To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

• To assess the concentrations of REGN10933 and REGN10987 in serum over time

• To assess the immunogenicity of REGN10933 and REGN10987

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1149
• Est. completion date: September 21, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Has SARS-CoV-2-positive diagnostic test from a sample collected =72 hours prior to randomization, as defined by the protocol

• Low-risk symptomatic patient: Has symptoms consistent with COVID-19 (as determined by the investigator) with onset =7 days before randomization, and meets all of the following 8 criteria:

1. Age =50

2. No obesity, with obesity defined as BMI =30 kg/m2

3. Does not have cardiovascular disease or hypertension

4. Does not have chronic lung disease or asthma

5. Does not have type 1 or type 2 diabetes mellitus

6. Does not have chronic kidney disease, with or without dialysis

7. Does not have chronic liver disease

8. Is not pregnant or

• Asymptomatic patient: Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time <2 months prior to randomization

• Maintains O2 saturation =93% on room air

Key Exclusion Criteria:

• Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization

• Has a known positive SARS-CoV-2 serologic test

• Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected >72 hours prior to randomization

• Is immunosuppressed, based on investigator's assessment

• 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, (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 time period given per CDC guidance but no sooner than 22 days of study drug administration) of any authorized or approved vaccine for COVID-19

• Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test

• Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19

NOTE: Other protocol defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
• Placebo
Administered IV or SC single dose to match

Locations

Country	Name	City	State
United States	Regeneron Study Site	Amarillo	Texas
United States	Regeneron Study Site	Ames	Iowa
United States	Regeneron Study Site	Atlanta	Georgia
United States	Regeneron Study Site	Baltimore	Maryland
United States	Regeneron Study Site	Bronx	New York
United States	Regeneron Study Site	Canoga Park	California
United States	Regeneron Study Site	Charleston	South Carolina
United States	Regeneron Study Site	Charlotte	North Carolina
United States	Regeneron Study Site	Clinton	South Carolina
United States	Regeneron Study Site	Colorado Springs	Colorado
United States	Regeneron Study Site	Columbus	Ohio
United States	Regeneron Study Site	Columbus	Georgia
United States	Regeneron Study Site	Corpus Christi	Texas
United States	Regeneron Study Site	Dayton	Ohio
United States	Regeneron Study Site	Dayton	Ohio
United States	Regeneron Study Site	DeLand	Florida
United States	Regeneron Study Site	Downers Grove	Illinois
United States	Regeneron Study Site	Durham	North Carolina
United States	Regeneron Study Site	Falls Church	Virginia
United States	Regeneron Study Site	Fort Pierce	Florida
United States	Regeneron Study Site	Hialeah	Florida
United States	Regeneron Study Site	Hialeah	Florida
United States	Regeneron Study Site	Houston	Texas
United States	Regeneron Study Site	Houston	Texas
United States	Regeneron Study Site	Houston	Texas
United States	Regeneron Study Site	Houston	Texas
United States	Regeneron Study Site	Iowa City	Iowa
United States	Regeneron Study Site	Lake Charles	Louisiana
United States	Regeneron Study Site	Las Vegas	Nevada
United States	Regeneron Study Site	Long Beach	California
United States	Regeneron Study Site	Los Angeles	California
United States	Regeneron Study Site	Maitland	Florida
United States	Regeneron Study Site	Marrero	Louisiana
United States	Regeneron Study Site	Mesa	Arizona
United States	Regeneron Study Site	Miami	Florida
United States	Regeneron Study Site	Miami	Florida
United States	Regeneron Study Site	New York	New York
United States	Regeneron Study Site	Pearland	Texas
United States	Regeneron Study Site	Philadelphia	Pennsylvania
United States	Regeneron Study Site	Red Oak	Texas
United States	Regeneron Study Site	Rolling Hills Estates	California
United States	Regeneron Study Site	Saint Petersburg	Florida
United States	Regeneron Study Site	San Antonio	Texas
United States	Regeneron Study Site	San Francisco	California
United States	Regeneron Study Site	Santa Monica	California
United States	Regeneron Study Site	Shreveport	Louisiana
United States	Regeneron Study Site	Splendora	Texas
United States	Regeneron Study Site	Stanford	California
United States	Regeneron Study Site	Tampa	Florida
United States	Regeneron Study Site	Teaneck	New Jersey
United States	Regeneron Study Site	Tucson	Arizona
United States	Regeneron Study Site	Tyler	Texas
United States	Regeneron Study Site	Washington	District of Columbia
United States	Regeneron Study Site	West Palm Beach	Florida
United States	Regeneron Study Site	Wilmington	North Carolina
United States	Regeneron Study Site	Winter Haven	Florida
United States	Regeneron Study Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples	Time-weighted average daily change from Day 1 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.	Day 1 to Day 7
Secondary	Time-Weighted Average Daily Change From Day 1 in Viral Load	Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.	Day 1 to Day 5
Secondary	Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline	Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline.	Day 1 to Day 7
Secondary	Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline	Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline.	Day 1 to Day 5
Secondary	Number of Participants With High Viral Load	Number of participants with viral load greater than 10,000 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.	Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Secondary	Number of Participants With Viral Loads Below the Limit of Detection	Number of participants with viral load less than 299 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.	Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Secondary	Number of Participants With Viral Loads Below the Lower Limit of Quantification	Number of participants with viral load less than 714 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.	Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Secondary	Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples	Change from Day 1 in Viral Load (log10 copies/mL) as Measured by Quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) Swab Samples	Day 3, Day 5, Day 7, Day 15, Day 22
Secondary	Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)		Through day 29
Secondary	Number of Participants With Infusion-Related Reactions Grade 2 or Above		Through day 4
Secondary	Number of Participants With Injection-Site Reactions Grade 3 or Above		Through day 4
Secondary	Number of Participants With Hypersensitivity Reactions Grade 2 or Above		Through day 29
Secondary	Concentration of REGN10933 in Serum		Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose
Secondary	Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933		Through day 120
Secondary	Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933		Through day 120
Secondary	Concentration of REGN10987 in Serum		Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose
Secondary	Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987		Through day 120
Secondary	Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987		Through day 120