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drug1682 | Interleukin 6 (IL6) Antagonist Wiki | 0.50 |
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There are 4 clinical trials
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 load of SARS-CoV-2 Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 3 - Cohort 1 (Patients ≥18 Years) • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by COVID-19-related medically-attended visits - Cohort 2 (Patients 0 to <18 Years) - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo - To characterize further the concentrations of REGN10933 and REGN10987 in serum over time - To assess the immunogenicity of REGN10933 and REGN10987
Description: Primary: Phase 1, Phase 3 (Cohort 2) Secondary: Phase 2, Phase 3 (Cohort 1)
Measure: Proportion of patients with treatment-emergent serious adverse events (SAEs) Time: Through Day 29Description: Primary: Phase 1, Phase 3 (Cohort 2) Secondary: Phase 2, Phase 3 (Cohort 1)
Measure: Proportion of patients with infusion-related reactions Time: Through Day 4Description: Primary: Phase 1, Phase 3 (Cohort 2) Secondary: Phase 2, Phase 3 (Cohort 1)
Measure: Proportion of patients with hypersensitivity reactions Time: Through Day 29Description: Phase 1 Only
Measure: Time-weighted average change from baseline in viral load (log10 copies/mL), 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 2 Secondary: Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in NP swab samples Time: Baseline up to Day 7Description: Primary: Phase 3 (Cohort 1) Secondary: Phase 3 (Cohort 2)
Measure: Cumulative Incidence of COVID-19 related medically attended visits Time: Through Day 29Description: Primary: Phase 3 (Cohort 2) Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1)
Measure: Concentration of REGN10933 in serum over time Time: Through Day 29Description: Primary: Phase 3 (Cohort 2) Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1)
Measure: Concentration of REGN10987 in serum over time Time: Through Day 29Description: Primary: Phase 3 (Cohort 2) Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1)
Measure: Incidence of anti-drug antibodies (ADA) to REGN10933 Time: Through Day 29Description: Primary: Phase 3 (Cohort 2) Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1)
Measure: Incidence of ADA to REGN10987 Time: Through Day 29Description: Primary: Phase 3 (Cohort 2) Secondary: Phase 3 (Cohort 1)
Measure: Incidence of neutralizing antibody (NAb) to REGN10933 Time: Through Day 29Description: Primary: Phase 3 (Cohort 2) Secondary: Phase 3 (Cohort 1)
Measure: Incidence of NAb to REGN10987 Time: Through Day 29Description: Phase 1 Only
Measure: Time-weighted average change from baseline in viral load (log10 copies/mL), as 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 load (log10 copies/mL), as 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 Only
Measure: Time to negative RT-qPCR in NP swabs with no subsequent positive RT-qPCR Time: Through Day 29Description: Phase 1, Phase 2, Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Change from baseline in viral load at each visit, as measured by RT-qPCR in NP swabs Time: Baseline up to Day 29Description: Phase 1 Only
Measure: Change from baseline in viral load at each visit, as measured by RT-qPCR in saliva samples Time: Baseline up to Day 29Description: Phase 1 Only
Measure: Change from baseline in viral load at each visit, 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 1, Phase 2
Measure: Time-weighted average change from baseline in viral load (log10 copies/mL) from day 1 to post-baseline study days Time: Day 1 to Day 29Description: Phase 1, Phase 2, Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Proportion of participants with at least one COVID-19 related medically-attended visit Time: Through Day 29Description: Phase 1, Phase 2, Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Proportion of participants with at least two COVID-19 related medically-attended visit Time: Through Day 29Description: Phase 1, Phase 2, Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Total number of COVID-19 related medically-attended visits Time: Through Day 29Description: Phase 1, Phase 2
Measure: Proportion of participants admitted to a hospital due to COVID-19 Time: Through Day 29Description: Phase 2, Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19 Time: Through Day 29Description: Phase 1, Phase 2
Measure: Proportion of participants with at least 1 outpatient or telemedicine visit due to COVID-19 Time: Through Day 29Description: Phase 2, Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Proportion of participants requiring mechanical ventilation due to COVID-19 Time: Through Day 29Description: Phase 2, Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Number of days of hospitalization due to COVID-19 Time: Through Day 29Description: Phase 2 Only
Measure: Proportion of participants with All-Cause Mortality Time: Through Day 29Description: Phase 2 Only
Measure: Time to first onset of symptoms consistent with COVID-19 (asymptomatic cohort only) Time: Up to Day 29Description: Phase 2 Only
Measure: Duration of symptoms consistent with COVID-19 Time: Up to 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 29Description: Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Cumulative incidence of COVID-19-related hospitalizations or emergency room visits Time: Through Day 29Description: Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Cumulative incidence of COVID-19-related hospitalizations Time: Through Day 29Description: Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Cumulative incidence of COVID-19-related emergency room visits Time: Through Day 29Description: Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Proportion of participants requiring supplemental oxygen due to COVID-19 Time: Through Day 29Description: Phase 2 Only
Measure: Proportion of participants with high viral load at each visit Time: Through Day 29Description: Phase 2 Only
Measure: Proportion of participants with viral loads below the limit of detection at each visit Time: Through Day 29Description: Phase 2 Only
Measure: Proportion of participants with viral loads below the lower limit of quantitation at each visit Time: Through Day 29Description: Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Time to All-Cause Mortality Time: Through Day 169Description: Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: All-Cause Mortality Time: At Day 29, Day 120, and Day 169Description: Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Viral load over time in participants with COVID-19-related medically-attended visits Time: Through Day 29Description: Phase 3 (Cohort 1), Phase 3 (Cohort 2)
Measure: Viral load over time in participants without COVID-19-related medically-attended visits Time: Through Day 29The primary objectives are: Phase 1/2 (Cohort 1) - To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo Phase 2 (Cohort 1A) - To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo Phase 3 (Cohort 1 and Cohort 1A) - To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
Description: Primary: Through Day 169: Phase 1/2: C1 (Futility) Through Day 57: Phase 2: C1A (Clinical Efficacy) Timeframe determined based on Phase 1/2 data: Phase 3, C1, C1A (Clinical Efficacy) Secondary (Clinical Efficacy): Through Day 169: Phase 1/2: C1 Through Day 57: Phase 2: C2 Timeframe determined based on Phase 1/2 data: Phase 3: C1, C1A
Measure: Incidence of death or required mechanical ventilation Time: Through day 169Description: Primary: Through Day 169: Phase 1/2: C1 Through Day 57: Phase 2, C1A Secondary: Through Day 57: Phase 2: C2, C3
Measure: Proportion of patients with treatment-emergent Serious Adverse Events (SAEs) Time: Through Day 169Description: Primary: Phase 1/2: C1, Phase 2: C1A Secondary: Phase 2: C2, C3
Measure: Proportion of patients with infusion-related reactions Time: Through Day 4Description: Primary: Phase 1/2: C1, Phase 2: C1A Secondary: Phase 2: C2, C3
Measure: Proportion of patients with hypersensitivity reactions Time: Through Day 29Description: Phase 1/2: C1, Phase 2: C1A, C2, C3, Phase 3: C1, C1A
Measure: Time-weighted average change from baseline in viral load as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples Time: Baseline to Day 7Description: Phase 1/2: C1, Phase 2: C1A, C2, C3, Phase 3: C1, C1A
Measure: Time-weighted average change from baseline in viral load as measured by RT-qPCR in NP swab samples Time: Baseline up to Day 11Description: Phase 1/2: C1, Phase 2: C1A, C2, C3, Phase 3: C1, C1A
Measure: Time-weighted average change from baseline in viral load as measured by RT-qPCR in NP swab samples Time: Baseline up to Day 29Description: Phase 1/2: C1, Phase 2: C1A, C2, C3, Phase 3: C1, C1A
Measure: Change from baseline in viral load as measured by RT-qPCR in NP swabs Time: Baseline up to Day 29Description: Negative RT-qPCR with no subsequent positive Phase 1/2: C1, Phase 2; C1A, C2, C3, Phase 3: C1, C1A
Measure: Time to sustained negative RT-qPCR in NP swab samples Time: Up To Day 29Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 57: Phase 2: C1A, C2, C3
Measure: Incidence of deaths due to any cause Time: Through Day 169Description: Through Day 29: Phase 1/2: C1, Phase 2: C1A, C2, Phase 3: C1, C1A
Measure: Incidence of required mechanical ventilation Time: Through Day 29Description: Phase 1/2: C1, Phase 2: C1A, C2, Phase 3: C1, C1A
Measure: Proportion of patients who died or went on mechanical ventilation Time: By Day 29Description: Phase 1/2: C1, Phase 2: C1A, C2, C3, Phase 3: C1, C1A
Measure: Proportion of patients who died Time: By Day 29Description: Phase 1/2: C1, Phase 2: C1A, C2, Phase 3: C1, C1A
Measure: Proportion of patients who went on mechanical ventilation Time: By Day 29Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Time to discharge Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Serum concentration of REGN10933 over time Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Serum concentration of REGN10987 over time Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933 Time: Through day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987 Time: Through day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10933 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10987 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10933 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10987 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
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: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
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: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10933 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10987 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10933 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10987 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Observed terminal half-life [t1/2] for REGN10933 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Observed terminal half-life [t1/2] of REGN10987 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Clearance (CL) for REGN10933 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Clearance (CL) of REGN10987 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10933 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10987 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Mean residence time (MRT) of REGN10933 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Assessment of PK parameter: Mean residence time (MRT) of REGN10987 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Incidence of anti-drug antibodies (ADA) to REGN10933 Time: Through Day 169Description: Through Day 169: Phase 1/2: C1, Phase 3: C1, C1A Through Day 29: Phase 2: C1A, C2, C3
Measure: Incidence of anti-drug antibodies (ADA) to REGN10987 Time: Through Day 169Provide Compassionate Use access to REGN-COV2 for adult patients with recently diagnosed mild-to-moderate coronavirus disease (COVID-19) who are at high risk for poor outcomes.
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
Description: Measured in patients who have a central-lab determined RT-qPCR positive test and are seronegative at baseline
Measure: Time-weighted average daily change from baseline in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples Time: Baseline to day 7Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports