Phase 2
Completed N=1,149
COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection
Source: ClinicalTrials.gov NCT04666441 ↗Enrolled (actual)
1,149
Serious AEs
0.6%
Results posted
Apr 2022
Primary outcomePrimary: Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples — -1.68; -2.25; -2.34; -2.24 log10 copies/mL — p=0.0004
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples |
-1.68; -2.25; -2.34; -2.24; -2.40; -2.24 | 0.0004 sig |
| SECONDARY Time-Weighted Average Daily Change From Day 1 in Viral Load |
-1.19; -1.66; -1.76; -1.77; -1.68; -1.56 | 0.0002 sig |
| SECONDARY Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline |
-1.28; -1.69; -1.73; -1.76; -1.68; -1.62 | 0.0005 sig |
| SECONDARY Number of Participants With High Viral Load |
108; 106; 96; 95; 91; 99 | — |
| SECONDARY Number of Participants With Viral Loads Below the Limit of Detection |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Viral Loads Below the Lower Limit of Quantification |
0; 1; 0; 0; 0; 3 | — |
| SECONDARY Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples |
-1.22; -1.71; -1.91; -1.85; -1.69; -1.55 | 0.0070 sig |
| SECONDARY Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) |
0; 0; 0; 0; 2; 0 | — |
| SECONDARY Number of Participants With Infusion-Related Reactions Grade 2 or Above |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Injection-Site Reactions Grade 3 or Above |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Hypersensitivity Reactions Grade 2 or Above |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Concentration of REGN10933 in Serum |
0.529; 1.95; 0.847; 13.3; 0.992; 0.395 | — |
| SECONDARY Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 |
3; 2; 3; 0; 2; 1 | — |
| SECONDARY Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 |
4; 11; 7; 6; 0; 13 | — |
| SECONDARY Concentration of REGN10987 in Serum |
0.529; 2.04; 0.823; 13.1; 1.02; 0.370 | — |
| SECONDARY Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 |
3; 4; 0; 3; 3; 3 | — |
| SECONDARY Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 |
1; 2; 0; 2; 1; 2 | — |
Eligibility Criteria
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:
- Age ≤50
- No obesity, with obesity defined as BMI ≥30 kg/m2
- Does not have cardiovascular disease or hypertension
- Does not have chronic lung disease or asthma
- Does not have type 1 or type 2 diabetes mellitus
- Does not have chronic kidney disease, with or without dialysis
- Does not have chronic liver disease
- Is not pregnant or
- Asymptomatic patient: Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time 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
Data sourced from ClinicalTrials.gov (NCT04666441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.