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REGN10933+REGN10987 combination therapyWiki

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


Correlated Drug Terms (4)


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

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials


1 A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19

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

NCT04425629 COVID-19 Drug: REGN10933+REGN10987 combination therapy Drug: Placebo

Primary Outcomes

Description: Primary: Phase 1 Secondary: Phase 2, Phase 3

Measure: Proportion of patients with treatment-emergent serious adverse events (SAEs)

Time: Through Day 29

Description: Primary: Phase 1 Secondary: Phase 2, Phase 3

Measure: Proportion of patients with infusion-related reactions

Time: Through Day 4

Description: Primary: Phase 1 Secondary: Phase 2, Phase 3

Measure: Proportion of patients with hypersensitivity reactions

Time: Through Day 29

Description: 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 22

Description: 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 29

Secondary Outcomes

Description: 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 22

Description: 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 22

Description: 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 29

Description: Phase 2, Phase 3

Measure: Time to negative RT-qPCR in NP swabs with no subsequent positive RT-qPCR

Time: Through Day 29

Measure: Change from baseline in viral shedding as measured by RT-qPCR in NP swabs

Time: Baseline up to Day 29

Description: Phase 1 Only

Measure: Change from baseline in viral shedding as measured by RT-qPCR in saliva samples

Time: Baseline up to Day 29

Description: Phase 1 Only

Measure: Change from baseline in viral shedding as measured by RT-qPCR in nasal swabs

Time: Baseline up to Day 29

Description: Phase 1 Only

Measure: Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva)

Time: Up to Day 29

Description: Phase 1 Only

Measure: Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva)

Time: Up to Day 29

Measure: Time-weighted average change from baseline in viral shedding

Time: Baseline up to Day 29

Measure: Proportion of patients with at least two COVID-19 related medically attended visits

Time: Through Day 29

Measure: Total number of COVID-19 related medically-attended visits

Time: Through Day 29

Measure: Proportion of patients admitted to a hospital due to COVID-19

Time: Through Day 29

Description: Phase 2, Phase 3

Measure: Proportion of patients admitted to an intensive care unit (ICU) due to COVID-19

Time: Through Day 29

Measure: Proportion of patients at least 1 outpatient or telemedicine visit due to COVID-19

Time: Through Day 29

Description: Phase 2, Phase 3

Measure: Proportion of patients requiring mechanical ventilation due to COVID-19

Time: Through Day 29

Description: Phase 2, Phase 3

Measure: Number of days of hospitalization due to COVID-19

Time: Through Day 29

Description: Phase 2, Phase 3

Measure: Number of deaths due to any cause (All-Cause Mortality)

Time: Through Day 29

Measure: Serum concentration of REGN10933 over time

Time: Through Day 29

Measure: Serum concentration of REGN10987 over time

Time: Through Day 29

Description: Phase 1 only

Measure: Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933

Time: Through Day 29

Description: Phase 1 only

Measure: Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987

Time: Through Day 29

Description: Phase 1 only

Measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933

Time: Through Day 29

Description: Phase 1 only

Measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987

Time: Through Day 29

Description: Phase 1 only

Measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10933

Time: Through Day 29

Description: Phase 1 only

Measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10987

Time: Through Day 29

Description: 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 29

Description: 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 29

Measure: Incidence of anti-drug antibodies (ADA) to REGN10933

Time: Through Day 29

Measure: Incidence of anti-drug antibodies (ADA) to REGN10987

Time: Through Day 29

2 A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19

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 - 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

NCT04426695 COVID-19 Drug: REGN10933+REGN10987 combination therapy Drug: Placebo

Primary Outcomes

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 169

Description: Primary: Phase 1:C1 Secondary: Phase 2: C1, C2, C3

Measure: Proportion of patients with infusion-related reactions

Time: Through Day 4

Description: Primary: Phase 1:C1 Secondary: Phase 2: C1, C2, C3

Measure: Proportion of patients with hypersensitivity reactions

Time: Through Day 29

Description: 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 22

Description: 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 29

Secondary Outcomes

Description: 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 22

Description: 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 22

Description: 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 29

Description: Phase 2: C1, C2, C3

Measure: Time to negative RT-qPCR in NP swabs with no subsequent positive RT-qPCR

Time: Through Day 29

Description: 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 29

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Time-weighted average change in viral shedding

Time: Baseline up to Day 29

Description: Phase 1: C1

Measure: Change from baseline in viral shedding as measured by RT-qPCR in saliva samples

Time: Baseline up to Day 29

Description: Phase 1: C1

Measure: Change from baseline in viral shedding as measured by RT-qPCR in nasal swabs

Time: Baseline up to Day 29

Description: Phase 1: C1

Measure: Correlation of RT-qPCR results over time between different sample types

Time: Up to Day 29

Description: Phase 1: C1

Measure: Concordance of RT-qPCR results over time between different sample types

Time: Up to Day 29

Description: 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 29

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Time to no longer requiring oxygen supplementation

Time: Through Day 29

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Number of days of supplemental oxygen use

Time: Through Day 29

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Proportion of patients initiating high-intensity oxygen therapy

Time: Up to Day 29 or hospital discharge

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Number of days of high-intensity oxygen therapy

Time: Through Day 29

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Proportion of patients initiating mechanical ventilation

Time: Up to Day 29 or hospital discharge

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Number of days of mechanical ventilation

Time: Through Day 29

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Number of Ventilator-free days

Time: Through Day 29

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Number of days of hospitalization

Time: Through Day 29

Description: 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 169

Description: 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 169

Description: Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 57

Measure: Overall Survival

Time: Through Day 169

Description: Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 29

Measure: Serum concentration of REGN10933 over time

Time: Through Day 169

Description: Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 29

Measure: Serum concentration of REGN10987 over time

Time: Through Day 169

Description: 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 169

Description: 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 169

Description: Phase 1 only

Measure: Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933

Time: Through day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987

Time: Through day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10933

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10987

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10933

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10987

Time: Through Day 169

Description: 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 169

Description: 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 169

Description: Phase 1 only

Measure: Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10933

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10987

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10933

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10987

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Observed terminal half-life [t1/2] for REGN10933

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Observed terminal half-life [t1/2] of REGN10987

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Clearance (CL) for REGN10933

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Clearance (CL) of REGN10987

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10933

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10987

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Mean residence time (MRT) of REGN10933

Time: Through Day 169

Description: Phase 1 only

Measure: Assessment of PK parameter: Mean residence time (MRT) of REGN10987

Time: Through Day 169

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Proportion of patients admitted into an intensive care unit (ICU)

Time: Up to Day 29

Description: Phase 1: C1 Phase 2: C1, C2, C3

Measure: Days of ICU stay

Time: Up to Day 29


No related HPO nodes (Using clinical trials)