Back to resultsA Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19
Primary Purpose
Covid-19, Coronavirus Disease 2019
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bempegaldesleukin
Standard of Care
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid-19 focused on measuring BEMPEG, Bempegaldesleukin, CD122, CD122-Biased Agonist, CD122-Biased Cytokine, Coronavirus Disease, COVID-19, IL-2 receptor agonist, Lymphopenia, Mild COVID, NKTR-214, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus 2
Eligibility Criteria
Inclusion Criteria:
- Male or female patients, age 18 years or older on the day of signing the informed consent form.
- Agrees to admission to an in-patient facility for monitoring from Days 1 to 8, inclusive.
- Symptoms of mild illness with COVID-19 without shortness of breath, dyspnea, or clinical signs indicative of more serious COVID-19.
- Laboratory confirmed SARS-CoV-2 infection within 4 days prior to the screening visit or during the 7-day screening period.
- Respiratory rate < 20 breaths per minute, heart rate < 90 beats per minute (bpm).
- Oxygen saturation by pulse oximetry > 93% on room air.
- Body mass index < 35 kg/m2.
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
- Alanine transaminase (ALT) or aspartate transaminase (AST) < 2 x upper limit of normal (ULN) and total bilirubin < 1.5 x ULN.
- Agrees to not participate in another clinical trial for the treatment of COVID-19 while on study unless the patient's condition has worsened and is considered to be moderate, severe, or critical by the Investigator.
Exclusion Criteria:
- Shortness of breath, hypoxia, or signs of serious lower airway disease.
- C-reactive protein, lactate dehydrogenase (LDH), or interleukin-6 (IL-6) > 1.5 x ULN.
- D-dimer or ferritin > 1.5 x ULN.
- Imminently requiring, or currently on, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- Systolic blood pressure < 90 mm Hg or diastolic blood pressure < 60 mm Hg.
- Evidence of acute respiratory distress syndrome (ARDS) or systemic inflammatory response syndrome (SIRS)/shock.
- Known cardiovascular history, including unstable or deteriorating cardiac disease.
- Autoimmune disease.
- History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-cerebrovascular accident/transient ischemic attack arterial thromboembolic event.
- Central nervous system disease or dysfunction.
- Requirement for > 2 anti-hypertensive medications.
- Unwilling to refrain from alcohol consumption from Day 1 of admission to the in-patient facility until discharge from the facility.
- Adrenal insufficiency.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- A G A Clinical Trials - HyperCore - PPDS
- New Generation Medical Research
- Clinical Site Partners - Winter Park - HyperCore -PPDS
- SMS Clinical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bempegaldesleukin IV + Standard of Care
Placebo + Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
AUC of BEMPEG/standard of care (SOC) (PK).
Area under the serum concentration-time curve (AUC) of BEMPEG /SOC.
Cmax of BEMPEG /SOC (PK).
Maximum observed serum concentration (Cmax) of BEMPEG /SOC.
Tmax of BEMPEG /SOC (PK).
Time to Cmax (Tmax) of BEMPEG /SOC.
Incidence of adverse events.
Incidence of treatment emergent adverse events (TEAEs).
Incidence of serious adverse events (SAEs).
Incidence of dose limiting toxicities (DLT) for BEMPEG.
Presence and levels of anti-drug antibodies directed to BEMPEG.
Fold change from baseline in absolute lymphocyte count by Central Laboratory.
Secondary Outcome Measures
Percentage of patients who require supplemental oxygen.
Change from baseline on the daily collection World Health Organization (WHO) Clinical Progression Scale, an 11-point clinical status ordinal scale.
The WHO Clinical Progression Scale scores and descriptors are as follows:
0- Uninfected; no viral RNA detected; 1- Asymptomatic; viral RNA detected; 2- Symptomatic; independent; 3- Symptomatic; assistance needed; 4- Hospitalized, no oxygen therapy; 5- Hospitalized; oxygen by mask or nasal prongs ; 6- Hospitalized; oxygen by non-invasive ventilation or high-flow; 7- Intubation and mechanical ventilation, PaO2/FiO2 ≥ 150 or SpO2/FiO2 ≥ 200; 8- Mechanical ventilation, PaO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors; 9- Mechanical ventilation, PaO2/FiO2 < 150 and vasopressors, dialysis, or ECMO; 10- Death
Abbreviations: ECMO = extracorporeal membrane oxygenation; FiO2 = fraction of inspired oxygen; PaO2 = partial pressure of arterial oxygen; SpO2 = oxygen saturation If hospitalized for isolation only, record status as for ambulatory patient. Source: WHO 2020.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04646044
Brief Title
A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19
Official Title
A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Mild COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nektar Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose of this phase-1b, multicenter, randomized double-blind, placebo-controlled, trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bempegaldesleukin (BEMPEG; NKTR-214) in combination with standard of care (SOC) in adult patients with mild COVID-19 (coronavirus disease 2019). The trial will also define the recommended phase 2 dose (RP2D) of bempegaldesleukin in patients with mild COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Coronavirus Disease 2019
Keywords
BEMPEG, Bempegaldesleukin, CD122, CD122-Biased Agonist, CD122-Biased Cytokine, Coronavirus Disease, COVID-19, IL-2 receptor agonist, Lymphopenia, Mild COVID, NKTR-214, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bempegaldesleukin IV + Standard of Care
Arm Type
Experimental
Arm Title
Placebo + Standard of Care
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bempegaldesleukin
Other Intervention Name(s)
NKTR-214, BEMPEG
Intervention Description
Administered as an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care Treatment for COVID-19 Infection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administered as an intravenous infusion
Primary Outcome Measure Information:
Title
AUC of BEMPEG/standard of care (SOC) (PK).
Description
Area under the serum concentration-time curve (AUC) of BEMPEG /SOC.
Time Frame
Approximately 30 days
Title
Cmax of BEMPEG /SOC (PK).
Description
Maximum observed serum concentration (Cmax) of BEMPEG /SOC.
Time Frame
Approximately 30 days
Title
Tmax of BEMPEG /SOC (PK).
Description
Time to Cmax (Tmax) of BEMPEG /SOC.
Time Frame
Approximately 30 days
Title
Incidence of adverse events.
Time Frame
Approximately 30 days
Title
Incidence of treatment emergent adverse events (TEAEs).
Time Frame
Approximately 30 days
Title
Incidence of serious adverse events (SAEs).
Time Frame
Approximately 30 days
Title
Incidence of dose limiting toxicities (DLT) for BEMPEG.
Time Frame
Approximately 30 days
Title
Presence and levels of anti-drug antibodies directed to BEMPEG.
Time Frame
Approximately 30 days
Title
Fold change from baseline in absolute lymphocyte count by Central Laboratory.
Time Frame
Approximately 30 days
Secondary Outcome Measure Information:
Title
Percentage of patients who require supplemental oxygen.
Time Frame
Approximately 30 days
Title
Change from baseline on the daily collection World Health Organization (WHO) Clinical Progression Scale, an 11-point clinical status ordinal scale.
Description
The WHO Clinical Progression Scale scores and descriptors are as follows:
0- Uninfected; no viral RNA detected; 1- Asymptomatic; viral RNA detected; 2- Symptomatic; independent; 3- Symptomatic; assistance needed; 4- Hospitalized, no oxygen therapy; 5- Hospitalized; oxygen by mask or nasal prongs ; 6- Hospitalized; oxygen by non-invasive ventilation or high-flow; 7- Intubation and mechanical ventilation, PaO2/FiO2 ≥ 150 or SpO2/FiO2 ≥ 200; 8- Mechanical ventilation, PaO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors; 9- Mechanical ventilation, PaO2/FiO2 < 150 and vasopressors, dialysis, or ECMO; 10- Death
Abbreviations: ECMO = extracorporeal membrane oxygenation; FiO2 = fraction of inspired oxygen; PaO2 = partial pressure of arterial oxygen; SpO2 = oxygen saturation If hospitalized for isolation only, record status as for ambulatory patient. Source: WHO 2020.
Time Frame
Approximately 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients, age 18 years or older on the day of signing the informed consent form.
Agrees to admission to an in-patient facility for monitoring from Days 1 to 8, inclusive.
Symptoms of mild illness with COVID-19 without shortness of breath, dyspnea, or clinical signs indicative of more serious COVID-19.
Laboratory confirmed SARS-CoV-2 infection within 4 days prior to the screening visit or during the 7-day screening period.
Respiratory rate < 20 breaths per minute, heart rate < 90 beats per minute (bpm).
Oxygen saturation by pulse oximetry > 93% on room air.
Body mass index < 35 kg/m2.
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
Alanine transaminase (ALT) or aspartate transaminase (AST) < 2 x upper limit of normal (ULN) and total bilirubin < 1.5 x ULN.
Agrees to not participate in another clinical trial for the treatment of COVID-19 while on study unless the patient's condition has worsened and is considered to be moderate, severe, or critical by the Investigator.
Exclusion Criteria:
Shortness of breath, hypoxia, or signs of serious lower airway disease.
C-reactive protein, lactate dehydrogenase (LDH), or interleukin-6 (IL-6) > 1.5 x ULN.
D-dimer or ferritin > 1.5 x ULN.
Imminently requiring, or currently on, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Systolic blood pressure < 90 mm Hg or diastolic blood pressure < 60 mm Hg.
Evidence of acute respiratory distress syndrome (ARDS) or systemic inflammatory response syndrome (SIRS)/shock.
Known cardiovascular history, including unstable or deteriorating cardiac disease.
Autoimmune disease.
History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-cerebrovascular accident/transient ischemic attack arterial thromboembolic event.
Central nervous system disease or dysfunction.
Requirement for > 2 anti-hypertensive medications.
Unwilling to refrain from alcohol consumption from Day 1 of admission to the in-patient facility until discharge from the facility.
Adrenal insufficiency.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Nektar Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
A G A Clinical Trials - HyperCore - PPDS
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
New Generation Medical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Clinical Site Partners - Winter Park - HyperCore -PPDS
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
SMS Clinical Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19
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