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Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04426695
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 8, 2020
First Posted Date  ICMJE June 11, 2020
Last Update Posted Date September 21, 2020
Actual Study Start Date  ICMJE June 10, 2020
Estimated Primary Completion Date January 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2020)
  • Proportion of patients with treatment-emergent Serious Adverse Events (SAEs) [ Time Frame: Through Day 169 ]
    Primary: Up to Day 169: Phase 1: C1 Secondary: Up to Day 29: Phase 1: C1, Phase 2: C1A, C1, C2, C3 Up to Day 57: Phase 2: C1A, C1, C2, C3
  • Proportion of patients with infusion-related reactions [ Time Frame: Through Day 4 ]
    Primary: Phase 1:C1 Secondary: Phase 2: C1A, C1, C2, C3
  • Proportion of patients with hypersensitivity reactions [ Time Frame: Through Day 29 ]
    Primary: Phase 1:C1 Secondary: Phase 2: C1A, C1, C2, C3
  • 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 Frame: Baseline up to Day 22 ]
    Phase 1:C1 Phase 2: C1A, C1, C2, C3
  • Proportion of patients with at least 1-point improvement on a 7-Point Ordinal Scale in clinical status [ Time Frame: From Day 1 up to Day 29 ]
    Primary: Day 8: Phase 2: C1A, 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: C1A, 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
  • Proportion of patients with treatment-emergent Serious Adverse Events (SAEs) [ Time Frame: Through Day 169 ]
    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
  • Proportion of patients with infusion-related reactions [ Time Frame: Through Day 4 ]
    Primary: Phase 1:C1 Secondary: Phase 2: C1, C2, C3
  • Proportion of patients with hypersensitivity reactions [ Time Frame: Through Day 29 ]
    Primary: Phase 1:C1 Secondary: Phase 2: C1, C2, C3
  • Time-weighted average change from baseline viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples [ Time Frame: Baseline up to Day 22 ]
    Phase 1 only
  • Time-weighted average change from baseline viral shedding as measured by RT-qPCR in saliva samples [ Time Frame: Baseline up to Day 22 ]
    Primary: Phase 2:C1, C2, C3 Secondary: Phase 1:C1
  • Proportion of patients with at least 1-point improvement on a 7-Point Ordinal Scale in clinical status [ Time Frame: Day 1, Day 8, Day 22, Day 29 ]
    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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2020)
  • Time-weighted average change from baseline in viral shedding as measured by RT-qPCR in saliva samples [ Time Frame: Baseline up to Day 22 ]
    Phase 1: C1
  • Time-weighted average change from baseline in viral shedding as measured by RT-qPCR in nasal samples [ Time Frame: Baseline up to Day 22 ]
    Phase 1: C1
  • Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples [ Time Frame: Through Day 29 ]
    Phase 1: C1
  • Time to negative RT-qPCR in NP swabs with no subsequent positive RT-qPCR [ Time Frame: Through Day 29 ]
    Phase 2: C1A, C1, C2, C3
  • Change from baseline in viral shedding as measured by RT-qPCR in NP swabs [ Time Frame: Baseline up to Day 29 ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Time-weighted average change in viral shedding [ Time Frame: Baseline up to Day 29 ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Change from baseline in viral shedding as measured by RT-qPCR in saliva samples [ Time Frame: Baseline up to Day 29 ]
    Phase 1: C1
  • Change from baseline in viral shedding as measured by RT-qPCR in nasal swabs [ Time Frame: Baseline up to Day 29 ]
    Phase 1: C1
  • Correlation of RT-qPCR results over time between different sample types [ Time Frame: Up to Day 29 ]
    Phase 1: C1
  • Concordance of RT-qPCR results over time between different sample types [ Time Frame: Up to Day 29 ]
    Phase 1: C1
  • Proportion of patients with at least 2-point improvement on a 7-Point Ordinal Scale in clinical status [ Time Frame: From Day 1 up to Day 29 ]
    Phase 1: C1, Phase 2: C1A, C1 Day 8 Phase 2: C2, C3 Day 22 Phase 1: C1, Phase 2: C1A, C1, C2, C3 Day 29
  • Time to no longer requiring oxygen supplementation [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Number of days of supplemental oxygen use [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Proportion of patients initiating high-intensity oxygen therapy [ Time Frame: Up to Day 29 or hospital discharge ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Number of days of high-intensity oxygen therapy [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Proportion of patients initiating mechanical ventilation [ Time Frame: Up to Day 29 or hospital discharge ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Number of days of mechanical ventilation [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Number of Ventilator-free days [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Number of days of hospitalization [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Proportion of patients re-admitted to hospital after discharge through the end of study [ Time Frame: Through Day 169 ]
    Phase 1: C1: Through Day 169 Phase 2: C1A, C1, C2, C3: Through Day 57
  • Proportion of patients admitted into an intensive care unit (ICU) [ Time Frame: Up to Day 29 ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Days of ICU stay [ Time Frame: Up to Day 29 ]
    Phase 1: C1 Phase 2: C1A, C1, C2, C3
  • Number of deaths due to any cause (All-Cause Mortality) [ Time Frame: Through Day 169 ]
    Phase 1: C1 Through Day 29 and Day 169 Phase 2: C1A, C1, C2, C3 Through Day 29 and Day 57
  • Overall Survival [ Time Frame: Through Day 169 ]
    Phase 1: C1: Through Day 169 Phase 2: C1A, C1, C2, C3: Through Day 57
  • Serum concentration of REGN10933 over time [ Time Frame: Through Day 169 ]
    Phase 1: C1: Through Day 169 Phase 2: C1A, C1, C2, C3: Through Day 29
  • Serum concentration of REGN10987 over time [ Time Frame: Through Day 169 ]
    Phase 1: C1: Through Day 169 Phase 2: C1A, C1, C2, C3: Through Day 29
  • Incidence of anti-drug antibodies (ADA) to REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1: C1: Through Day 169 Phase 2: C1A, C1, C2, C3: Through Day 29
  • Incidence of anti-drug antibodies (ADA) to REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1: C1: Through Day 169 Phase 2: C1A, C1, C2, C3: Through Day 29
  • Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933 [ Time Frame: Through day 169 ]
    Phase 1 only
  • Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987 [ Time Frame: Through day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Time to Cmax (tmax) for REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Time to Cmax (tmax) for REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • 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 Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Observed terminal half-life [t1/2] for REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Observed terminal half-life [t1/2] of REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Clearance (CL) for REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Clearance (CL) of REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Mean residence time (MRT) of REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Mean residence time (MRT) of REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
  • Time-weighted average change from baseline viral shedding as measured by RT-qPCR in nasal samples [ Time Frame: Day 1 up to Day 22 ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples [ Time Frame: Through Day 57 ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Change from baseline in SARS-CoV-2 viral shedding as measured by RT-qPCR in NP swabs [ Time Frame: Baseline up to Day 29 ]
    Phase 1: C1
  • Change from baseline in SARS-CoV-2 viral shedding as measured by RT-qPCR in saliva samples [ Time Frame: Baseline up to Day 29 ]
    Phase 1: C1, Phase 2: C1, C2, C3
  • Change from baseline in SARS-CoV-2 viral shedding as measured by RT-qPCR in nasal swabs [ Time Frame: Baseline up to Day 29 ]
    Phase 1: C1, Phase 2: C1, C2, C3
  • Proportion of patients with at least 2-point improvement on a 7-Point Ordinal Scale in clinical status [ Time Frame: Baseline to Day 8, Day 22, Day 29 ]
    Phase 1: C1, Phase 2: C1 Day 8 Phase 2: C2, C3 Day 22 Phase 1: C1, Phase 2: C1, C2, C3 Day 29
  • Time to no longer requiring oxygen supplementation [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Number of days of supplemental oxygen use [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Proportion of patients initiating high-intensity oxygen therapy [ Time Frame: Up to Day 29 or hospital discharge ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Number of days of high-intensity oxygen therapy [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Proportion of patients initiating mechanical ventilation [ Time Frame: Up to Day 29 or hospital discharge ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Number of days of mechanical ventilation [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Number of Ventilator-free days [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Number of days of hospitalization [ Time Frame: Through Day 29 ]
    Phase 1: C1 Phase 2: C1, C2, C3
  • Proportion of patients re-admitted to hospital after discharge through the end of study [ Time Frame: Through Day 169 ]
    Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 57
  • Number of deaths due to any cause (All-Cause Mortality) [ Time Frame: Through Day 169 ]
    Phase 1: C1 Through Day 29 and Day 169 Phase 2: C1, C2, C3 Through Day 29 and Day 57
  • Overall Survival [ Time Frame: Through Day 57 ]
    Phase 1: C1: Through Day 169 Phase 2: C1, C2, C3: Through Day 57
  • Serum concentration of REGN10933 over time [ Time Frame: Through Day 57 ]
  • Serum concentration of REGN10987 over time [ Time Frame: Through Day 57 ]
  • Incidence of anti-drug antibodies (ADA) to REGN10933 [ Time Frame: Through Day 57 ]
  • Incidence of anti-drug antibodies (ADA) to REGN10987 [ Time Frame: Through Day 57 ]
  • Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933 [ Time Frame: Through day 169 ]
    Phase 1 only
  • Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987 [ Time Frame: Through day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Time to Cmax (tmax) for REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Time to Cmax (tmax) for REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • 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 Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Observed terminal half-life [t1/2] for REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Observed terminal half-life [t1/2] of REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Clearance (CL) for REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Clearance (CL) of REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Mean residence time (MRT) of REGN10933 [ Time Frame: Through Day 169 ]
    Phase 1 only
  • Assessment of PK parameter: Mean residence time (MRT) of REGN10987 [ Time Frame: Through Day 169 ]
    Phase 1 only
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
Official Title  ICMJE 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
Brief Summary

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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Phase 1/Phase 2/Phase 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: REGN10933+REGN10987 combination therapy
    Administered intravenously (IV) single dose
  • Drug: Placebo
    Placebo IV Single Dose
Study Arms  ICMJE
  • Experimental: On Low-Flow Oxygen
    Cohort 1 (C1): O2 saturation >93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device
    Interventions:
    • Drug: REGN10933+REGN10987 combination therapy
    • Drug: Placebo
  • Experimental: With COVID-19 symptoms but not requiring supplemental O2
    Cohort 1A (C1A): With COVID-19 symptoms but not requiring supplemental oxygen
    Interventions:
    • Drug: REGN10933+REGN10987 combination therapy
    • Drug: Placebo
  • Experimental: High O2 No Mechanical Ventilation
    Cohort 2 (C2): On high-intensity oxygen (O2) therapy but not on mechanical ventilation
    Interventions:
    • Drug: REGN10933+REGN10987 combination therapy
    • Drug: Placebo
  • Experimental: On Mechanical Ventilation
    Cohort 3 (C3): On mechanical ventilation
    Interventions:
    • Drug: REGN10933+REGN10987 combination therapy
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2020)
2970
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2020)
1860
Estimated Study Completion Date  ICMJE January 25, 2021
Estimated Primary Completion Date January 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization and no alternative explanation for current clinical condition. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable.
  • Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10 days before randomization
  • Hospitalized for COVID-19 illness for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:

    1. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
    2. Cohort 1: Maintains O2 saturation >93% on low-flow oxygen as defined in the protocol
    3. Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol
    4. Cohort 3: On mechanical ventilation

Key Exclusion Criteria:

  • Phase 1 Only: Patients maintaining O2 saturation >94% on room air
  • In the opinion of the investigator, unlikely to survive for >48 hours from screening
  • Receiving extracorporeal membrane oxygenation (ECMO)
  • Has new-onset stroke or seizure disorder during hospitalization
  • Initiated on renal replacement therapy due to COVID-19

NOTE: Other protocol defined inclusion / exclusion criteria apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04426695
Other Study ID Numbers  ICMJE R10933-10987-COV-2066
2020-002537-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP