Name (Synonyms) | Correlation | |
---|---|---|
drug2120 | Ruxolitinib plus simvastatin Wiki | 0.71 |
drug194 | Antibody-Rich Plasma from COVID-19 recovered patients Wiki | 0.71 |
drug2319 | Standard of Care Wiki | 0.14 |
drug1822 | Placebo Wiki | 0.08 |
Name (Synonyms) | Correlation | |
---|---|---|
D018352 | Coronavirus Infections NIH | 0.06 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
Name (Synonyms) | Correlation |
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There are 2 clinical trials
The primary objectives are: Phase 1 - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo - To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral shedding of SARS-CoV-2 Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral shedding of SARS-CoV-2 Phase 3 • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo
Description: Primary: Phase 1 Secondary: Phase 2, Phase 3
Measure: Proportion of patients with treatment-emergent serious adverse events (SAEs) Time: Through Day 29Description: Primary: Phase 1 Secondary: Phase 2, Phase 3
Measure: Proportion of patients with infusion-related reactions Time: Through Day 4Description: Primary: Phase 1 Secondary: Phase 2, Phase 3
Measure: Proportion of patients with hypersensitivity reactions Time: Through Day 29Description: Primary: Phase 1, Phase 2 Secondary: Phase 3
Measure: Time-weighted average change from baseline in viral shedding as measured by quantitative reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples Time: Baseline up to Day 22Description: Primary: Phase 3 Secondary: Phase 1, Phase 2
Measure: Proportion of patients with at least one COVID-19 related medically attended visit Time: Through Day 29Description: Phase 1 Only
Measure: Time-weighted average change from baseline in viral shedding measured by RT-qPCR in saliva samples Time: Baseline up to Day 22Description: Phase 1 Only
Measure: Time-weighted average change from baseline in viral shedding measured by RT-qPCR in nasal swab samples Time: Baseline up to Day 22Description: Phase 1 Only
Measure: Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples Time: Through Day 29Description: Phase 2, Phase 3
Measure: Time to negative RT-qPCR in NP swabs with no subsequent positive RT-qPCR Time: Through Day 29Description: Phase 1 Only
Measure: Change from baseline in viral shedding as measured by RT-qPCR in saliva samples Time: Baseline up to Day 29Description: Phase 1 Only
Measure: Change from baseline in viral shedding as measured by RT-qPCR in nasal swabs Time: Baseline up to Day 29Description: Phase 1 Only
Measure: Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva) Time: Up to Day 29Description: Phase 1 Only
Measure: Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva) Time: Up to Day 29Description: Phase 2, Phase 3
Measure: Proportion of patients admitted to an intensive care unit (ICU) due to COVID-19 Time: Through Day 29Description: Phase 2, Phase 3
Measure: Proportion of patients requiring mechanical ventilation due to COVID-19 Time: Through Day 29Description: Phase 2, Phase 3
Measure: Number of days of hospitalization due to COVID-19 Time: Through Day 29Description: Phase 2, Phase 3
Measure: Number of deaths due to any cause (All-Cause Mortality) Time: Through Day 29Description: Phase 1 only
Measure: Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933 Time: Through Day 29Description: Phase 1 only
Measure: Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987 Time: Through Day 29Description: Phase 1 only
Measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933 Time: Through Day 29Description: Phase 1 only
Measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987 Time: Through Day 29Description: Phase 1 only
Measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10933 Time: Through Day 29Description: Phase 1 only
Measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10987 Time: Through Day 29Description: Phase 1 only
Measure: Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933 Time: Through Day 29Description: Phase 1 only
Measure: Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987 Time: Through Day 29The primary objectives are: Phase 1 - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo - To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral shedding of SARS-CoV-2 Phase 2 - To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral shedding of SARS-CoV-2 - To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo in improving clinical status Phase 3 - To evaluate and confirm the clinical efficacy of REGN10933+REGN10987 compared to placebo in improving clinical status
Description: Primary: Up to Day 169: Phase 1: C1 Secondary: Up to Day 29: Phase 1: C1, Phase 2: C1, C2, C3 Up to Day 57: Phase 2: C1, C2, C3
Measure: Proportion of patients with treatment-emergent Serious Adverse Events (SAEs) Time: Through Day 169Description: Primary: Phase 1:C1 Secondary: Phase 2: C1, C2, C3
Measure: Proportion of patients with infusion-related reactions Time: Through Day 4Description: Primary: Phase 1:C1 Secondary: Phase 2: C1, C2, C3
Measure: Proportion of patients with hypersensitivity reactions Time: Through Day 29Description: Phase 1:C1 Phase 2: C1, C2, C3
Measure: Time-weighted average change from baseline in viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples Time: Baseline up to Day 22Description: Primary: Day 8: Phase 2:C1, Phase 3:C1 Day 22: Phase 2:C2, C3, Phase 3:C2, C3 Secondary: Day 8: Phase 1:C1 Day 29: Phase 1:C1, Phase 2:C1, C2, C3 7-point Ordinal Scale: Death; Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized
Measure: Proportion of patients with at least 1-point improvement on a 7-Point Ordinal Scale in clinical status Time: From Day 1 up to Day 29Description: Phase 1: C1
Measure: Time-weighted average change from baseline in viral shedding as measured by RT-qPCR in saliva samples Time: Baseline up to Day 22Description: Phase 1: C1
Measure: Time-weighted average change from baseline in viral shedding as measured by RT-qPCR in nasal samples Time: Baseline up to Day 22Description: Phase 1: C1
Measure: Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples Time: Through Day 29Description: Phase 2: C1, C2, C3
Measure: Time to negative RT-qPCR in NP swabs with no subsequent positive RT-qPCR Time: Through Day 29Description: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Change from baseline in viral shedding as measured by RT-qPCR in NP swabs Time: Baseline up to Day 29Description: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Time-weighted average change in viral shedding Time: Baseline up to Day 29Description: Phase 1: C1
Measure: Change from baseline in viral shedding as measured by RT-qPCR in saliva samples Time: Baseline up to Day 29Description: Phase 1: C1
Measure: Change from baseline in viral shedding as measured by RT-qPCR in nasal swabs Time: Baseline up to Day 29Description: Phase 1: C1
Measure: Correlation of RT-qPCR results over time between different sample types Time: Up to Day 29Description: Phase 1: C1
Measure: Concordance of RT-qPCR results over time between different sample types Time: Up to Day 29Description: Phase 1: C1, Phase 2: C1 Day 8 Phase 2: C2, C3 Day 22 Phase 1: C1, Phase 2: C1, C2, C3 Day 29
Measure: Proportion of patients with at least 2-point improvement on a 7-Point Ordinal Scale in clinical status Time: From Day 1 up to Day 29Description: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Time to no longer requiring oxygen supplementation Time: Through Day 29Description: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Number of days of supplemental oxygen use Time: Through Day 29Description: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Proportion of patients initiating high-intensity oxygen therapy Time: Up to Day 29 or hospital dischargeDescription: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Number of days of high-intensity oxygen therapy Time: Through Day 29Description: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Proportion of patients initiating mechanical ventilation Time: Up to Day 29 or hospital dischargeDescription: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Number of days of mechanical ventilation Time: Through Day 29Description: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Number of Ventilator-free days Time: Through Day 29Description: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Number of days of hospitalization Time: Through Day 29Description: Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 57
Measure: Proportion of patients re-admitted to hospital after discharge through the end of study Time: Through Day 169Description: Phase 1: C1 Through Day 29 and Day 169 Phase 2: C1, C2, C3 Through Day 29 and Day 57
Measure: Number of deaths due to any cause (All-Cause Mortality) Time: Through Day 169Description: Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 57
Measure: Overall Survival Time: Through Day 169Description: Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 29
Measure: Serum concentration of REGN10933 over time Time: Through Day 169Description: Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 29
Measure: Serum concentration of REGN10987 over time Time: Through Day 169Description: Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 29
Measure: Incidence of anti-drug antibodies (ADA) to REGN10933 Time: Through Day 169Description: Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 29
Measure: Incidence of anti-drug antibodies (ADA) to REGN10987 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933 Time: Through day 169Description: Phase 1 only
Measure: Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987 Time: Through day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10933 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10987 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10933 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10987 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10933 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10987 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10933 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10987 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Observed terminal half-life [t1/2] for REGN10933 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Observed terminal half-life [t1/2] of REGN10987 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Clearance (CL) for REGN10933 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Clearance (CL) of REGN10987 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10933 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10987 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Mean residence time (MRT) of REGN10933 Time: Through Day 169Description: Phase 1 only
Measure: Assessment of PK parameter: Mean residence time (MRT) of REGN10987 Time: Through Day 169Description: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Proportion of patients admitted into an intensive care unit (ICU) Time: Up to Day 29Description: Phase 1: C1 Phase 2: C1, C2, C3
Measure: Days of ICU stay Time: Up to Day 29