Name (Synonyms) | Correlation |
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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: Primary: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Secondary: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Incidence and severity of treatment-emergent adverse events (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 1 monthDescription: 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 A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive 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 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 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 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 that has an onset during the EAP 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: 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 Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of days of hospital and intensive care unit (ICU) stay in subjects 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 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 that has an onset during the EAP 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 A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Incidence and severity of TEAEs in baseline seropositive participants (based on central lab test) 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: Incidence and severity of symptomatic SARS-CoV-2 infection 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 23