Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04666441 | COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection | PHASE2 | COMPLETED | 1,149 | — | — | Dec 15, 2020 | Sep 21, 2021 | Apr 8, 2022 | 57 | United States |
| NCT04426695 | Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19 | PHASE1 | COMPLETED | 2,252 | — | — | Jun 10, 2020 | Oct 22, 2021 | Jan 27, 2023 | 123 | United States, Brazil +4 |
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.
Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.
Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.
Cumulative incidence percentage was estimated using Kaplan-Meier method.
Cumulative incidence percentage was estimated using Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| IV Dose 1 | EXPERIMENTAL | Combination therapy intravenous (IV) single dose |
| IV Dose 2 | EXPERIMENTAL | Combination therapy IV single dose |
| IV Dose 3 | EXPERIMENTAL | Combination therapy IV single dose |
| IV Dose 4 | EXPERIMENTAL | Combination therapy IV single dose |
| Placebo IV Dose | EXPERIMENTAL | Matching placebo IV single dose |
| SC Dose 1 | EXPERIMENTAL | Combination therapy subcutaneous (SC) single dose |
| SC Dose 2 | EXPERIMENTAL | Combination therapy SC single dose |
| Placebo SC Dose | EXPERIMENTAL | Matching placebo SC single dose |
| On Low-Flow Oxygen | EXPERIMENTAL | Cohort 1 (C1): O2 saturation \>93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device |
| With COVID-19 symptoms but not requiring supplemental O2 | EXPERIMENTAL | Cohort 1A (C1A): With COVID-19 symptoms but not requiring supplemental oxygen |
| High O2 No Mechanical Ventilation | EXPERIMENTAL | Cohort 2 (C2): On high-intensity oxygen (O2) therapy but not on mechanical ventilation |
| On Mechanical Ventilation | EXPERIMENTAL | Cohort 3 (C3): On mechanical ventilation |
| Name | Type | Description |
|---|---|---|
| REGN10933+REGN10987 combination therapy | DRUG | Administered IV or SC single dose |
| Placebo | DRUG | Administered IV or SC single dose to match |
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, a...