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REGN10933+REGN10987Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D007239 Infection NIH 0.06

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2

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

NCT04452318 Healthy Participants Drug: REGN10933+REGN10987 Drug: Placebo
MeSH:Infection

Primary Outcomes

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 month

Description: 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 month

Description: 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 months

Secondary Outcomes

Description: 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 month

Description: 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 month

Description: 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 month

Description: 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 months

Description: 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 months

Description: 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 month

Description: 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 month

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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-qPCR

Description: 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-qPCR

Description: 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 months

Description: 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 months

Description: 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


No related HPO nodes (Using clinical trials)