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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
Primary Objective: - To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (strict-term) confirmed by RT-qPCR - To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing asymptomatic or symptomatic SARS-CoV-2 infection confirmed by RT-qPCR - To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo
Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants who have a positive SARS-CoV-2 RT-qPCR (based on central lab test) and signs and symptoms (strict-term) of SARS-CoV-2 infection during the Efficacy assessment period (EAP) Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants who have a RT-qPCR confirmed SARS-CoV-2 infection (either symptomatic or asymptomatic) during the EAP Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants with treatment-emergent adverse events (TEAEs) and severity of TEAEs Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad term) during the EAP Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants who have a positive SARS-CoV-2 RT-qPCR and absence of signs and symptoms (strict term) during the EAP Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants who have a positive SARS-CoV-2 RT-qPCR and absence of signs and symptoms (broad term) during the EAP Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Number of days of symptomatic SARS-CoV-2 infection (strict-term) from the first day of the first sign or symptom until the last day of the last sign or symptom associated with the first positive SARS-CoV-2 RT-PCR that occurs during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Number of days of symptomatic SARS-CoV-2 infection (broad-term) from the first day of the first sign or symptom until the last day of the last sign or symptom associated with the first positive SARS-CoV-2 RT-PCR that occurs during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Time-weighted average of viral shedding (log10 copies/mL) from the first positive SARS CoV-2 RT-qPCR Nasopharyngeal (NP) swab sample (with an onset during the EAP) until the visit within the window including 22 days after the positive test during the EAP Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Maximum SARS-CoV-2 RT-qPCR log10 viral copies/mL in Nasopharyngeal (NP) swab samples among individuals with ≥1 RT-qPCR positive that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Area under the curve (AUC) in viral shedding (log10 copies/mL) from the first positive SARS-CoV-2 RT-qPCR NP swab sample until the first confirmed negative test, that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Number of medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP Time: Up to 8 monthsDescription: Daily responsibilities including work (employed adults) or school (matriculating students), or family obligations/responsibilities (childcare or eldercare) Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Number of days missed for daily responsibilities due to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Incidence of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Severity of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of baseline seropositive subjects (based on central lab test) with TEAEs and severity of TEAEs Time: Up to 8 monthsDescription: Pharmacokinetic (PK) parameters may include, but are not limited to: - Maximum observed plasma concentration (Cmax) - Cmax/Dose - Time of maximum observed plasma concentration (tmax) - Time of Clast (tlast) - Last measurable plasma concentration (Clast) - Area under plasma concentration-time curve from time 0 to infinity (AUCinf) - AUCinf/Dose - Elimination half-life (t1/2) - Concentration in serum 28 days (C28) after dosing) Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Concentrations of REGN10933 in serum over time and selected PK parameters Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Concentrations of REGN10987 in serum over time and selected PK parameters Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 over time Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 over time Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Proportion of participants who subsequently develop signs and symptoms (strict-term) of symptomatic SARS-CoV-2 infection during EAP Time: Within 14 and 28 days of a positive RT-qPCRDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Proportion of participants who subsequently develop signs and symptoms (broad-term) of symptomatic SARS-CoV-2 infection during EAP Time: Within 14 and 28 days of a positive RT-qPCRDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of days of symptomatic SARS CoV-2 infection (strict-term) Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of days of symptomatic SARS CoV-2 infection (broad-term) Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Time-weighted average change from baseline in viral shedding in NP swab samples until the visit within the window including day 23 Time: Until day 23Description: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Area under the curve (AUC) in viral shedding (log10 copies/mL) in NP swab samples until the first confirmed negative test Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Maximum SARS-CoV-2 RT-qPCR log10 viral copies/mL in NP swab samples Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of medically attended visits in emergency rooms or urgent care centers related to RT-qPCR confirmed SARS-CoV-2 infection Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection Time: Up to 8 monthsDescription: Daily responsibilities including work (employed adults) or school (matriculating students), or family obligations/responsibilities (childcare or eldercare) Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of days missed for daily responsibilities due to a RT-qPCR confirmed SARS-CoV-2 infection Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Proportion of participants with TEAEs and severity of TEAEs Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Incidence of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Severity of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods Time: Up to 8 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
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