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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bempegaldesleukin IV + Standard of Care | Experimental |
| |
| Placebo + Standard of Care | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bempegaldesleukin | Drug | Administered as an intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC of Bempegaldesleukin [Pharmacokinetic Parameter]. | Area under the serum concentration-time curve (AUC) of bempegaldesleukin calculated from time 0 to 168 hours. | Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose. |
| Cmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | Maximum observed serum concentration (Cmax) of bempegaldesleukin. | Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose. |
| Tmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | Time to maximum concentration of bempegaldesleukin. Cmax = maximum concentration. Tmax = time to maximum concentration. | Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose. |
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Safety and Tolerability of bempegaldesleukin (starting at dose 0.00075 mg/kg) in combination with SOC was evaluated by incidence of Treatment-Emergent Adverse Events of Any Grade, Grade 3-4, and Grade 5 (Death). | Safety and tolerability were evaluated from baseline up to approximately 30 days. |
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Dose finding for this study was based on the assessment of DLT of bempegaldesleukin dose levels. Number and percentage of patients with any DLT were summarized by bempegaldesleukin dose level in bempegaldesleukin plus SOC treatment groups [0.00075 mg/kg, N=5; 0.0015 mg/kg, N=5; and 0.003 mg/kg, N=5] and placebo plus SOC (N=15). Adverse events related to study drug(s) that were defined as DLTs included the following:
The event was considered a DLT if it was confirmed to be at least possibly related to study drug, met any of the above definitions, and was confirmed to have occurred in a patient treated with bempegaldesleukin. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Require Supplemental Oxygen. | The percentage of patients requiring supplemental oxygen was evaluated as part of disease measurements to assess efficacy. No patient in the study required supplemental oxygen. | From baseline, following the administration of study drug approximately up to 30 days. |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Nektar Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A G A Clinical Trials - HyperCore - PPDS | Hialeah | Florida | 33012 | United States | ||
| New Generation Medical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bempegaldesleukin 0.00075 mg/kg | Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2020 | Mar 28, 2023 |
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| Standard of Care | Drug | Standard of Care Treatment for COVID-19 Infection |
|
| Placebo | Other | Administered as an intravenous infusion |
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| The DLT evaluation period was up to approximately 7 days following the bempegaldesleukin treatment. |
| Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm. | To assess the effect of bempegaldesleukin on the time course and extent of changes in absolute lymphocyte counts (ALC). Data are reported by dose and arm for Day 8 compared to baseline. | ALC was evaluated from baseline up to 7 days (Day 8) following the study drug administration. |
| 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(a); 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. The data are reported for Day 8 by arm. There were no scores rated 3 and higher per this scale at any timepoint. Abbreviations: ECMO = extracorporeal membrane oxygenation; FiO2 = fraction of inspired oxygen; PaO2 = partial pressure of arterial oxygen; SpO2 = oxygen saturation (a) If hospitalized for isolation only, record status as for ambulatory patient. Source: WHO 2020. |
| From baseline up to 7 days (Day 8) following the study drug administration. |
| Hialeah |
| Florida |
| 33016 |
| United States |
| Clinical Site Partners - Winter Park - HyperCore -PPDS | Winter Park | Florida | 32789 | United States |
| SMS Clinical Research, LLC | Mesquite | Texas | 75149 | United States |
| FG001 |
| Bempegaldesleukin 0.0015 mg/kg |
Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| FG002 | Bempegaldesleukin 0.003 mg/kg | Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| FG003 | Placebo | Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration. All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bempegaldesleukin 0.00075 mg/kg | Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| BG001 | Bempegaldesleukin 0.0015 mg/kg | Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| BG002 | Bempegaldesleukin 0.003 mg/kg | Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| BG003 | Placebo | Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration. All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Systolic Blood Pressure (BP) | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure (BP) | Mean | Standard Deviation | mmHg |
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| Pulse Rate | Mean | Standard Deviation | beats/minute |
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| Respiration Rate | Mean | Standard Deviation | breaths/minute |
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| Oxygen Saturation at Room Air | Mean | Standard Deviation | % |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC of Bempegaldesleukin [Pharmacokinetic Parameter]. | Area under the serum concentration-time curve (AUC) of bempegaldesleukin calculated from time 0 to 168 hours. | Participants with PK concentration profile to enable AUC calculation. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/ml | Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose. |
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| Primary | Cmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | Maximum observed serum concentration (Cmax) of bempegaldesleukin. | Participants with PK concentration profile to enable Cmax calculation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose. |
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| Primary | Tmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | Time to maximum concentration of bempegaldesleukin. Cmax = maximum concentration. Tmax = time to maximum concentration. | Participants with PK concentration profile to enable Tmax calculation. | Posted | Median | Full Range | hours | Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose. |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Safety and Tolerability of bempegaldesleukin (starting at dose 0.00075 mg/kg) in combination with SOC was evaluated by incidence of Treatment-Emergent Adverse Events of Any Grade, Grade 3-4, and Grade 5 (Death). | Posted | Count of Participants | Participants | Safety and tolerability were evaluated from baseline up to approximately 30 days. |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Dose finding for this study was based on the assessment of DLT of bempegaldesleukin dose levels. Number and percentage of patients with any DLT were summarized by bempegaldesleukin dose level in bempegaldesleukin plus SOC treatment groups [0.00075 mg/kg, N=5; 0.0015 mg/kg, N=5; and 0.003 mg/kg, N=5] and placebo plus SOC (N=15). Adverse events related to study drug(s) that were defined as DLTs included the following:
The event was considered a DLT if it was confirmed to be at least possibly related to study drug, met any of the above definitions, and was confirmed to have occurred in a patient treated with bempegaldesleukin. | Posted | Count of Participants | Participants | The DLT evaluation period was up to approximately 7 days following the bempegaldesleukin treatment. |
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| Primary | Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm. | To assess the effect of bempegaldesleukin on the time course and extent of changes in absolute lymphocyte counts (ALC). Data are reported by dose and arm for Day 8 compared to baseline. | Analysis population included patients with both baseline and Day 8 ALC measures. | Posted | Mean | Standard Deviation | Percent change from baseline | ALC was evaluated from baseline up to 7 days (Day 8) following the study drug administration. |
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| Secondary | Percentage of Patients Who Require Supplemental Oxygen. | The percentage of patients requiring supplemental oxygen was evaluated as part of disease measurements to assess efficacy. No patient in the study required supplemental oxygen. | Posted | Number | % of participants | From baseline, following the administration of study drug approximately up to 30 days. |
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| Secondary | 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(a); 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. The data are reported for Day 8 by arm. There were no scores rated 3 and higher per this scale at any timepoint. Abbreviations: ECMO = extracorporeal membrane oxygenation; FiO2 = fraction of inspired oxygen; PaO2 = partial pressure of arterial oxygen; SpO2 = oxygen saturation (a) If hospitalized for isolation only, record status as for ambulatory patient. Source: WHO 2020. | Analysis population included patients with both baseline and Day 8 scores. | Posted | Count of Participants | Participants | From baseline up to 7 days (Day 8) following the study drug administration. |
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Adverse events will be reported starting immediately after the patient has been administered the first dose of study drug until 30 days after the last dose of study drug, up to a maximum of approximately 40 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bempegaldesleukin 0.00075 mg/kg | Bempegaldesleukin at dose of 0.00075 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG001 | Bempegaldesleukin 0.0015 mg/kg | Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG002 | Bempegaldesleukin 0.003 mg/kg | Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG003 | Placebo | Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration. All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. | 0 | 15 | 0 | 15 | 4 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patients with at Least One Treatment-Emergent Adverse Event (TEAE) | General disorders | MedRA 23.1 | Non-systematic Assessment | Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs on or after the treatment dose, and treatment-emergent period is from the study dose date up to 30 days after the study dose. |
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| Headache | Nervous system disorders | MedRA 23.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedRA 23.1 | Non-systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedRA 23.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedRA 23.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedRA 23.1 | Non-systematic Assessment |
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| Pain | General disorders | MedRA 23.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedRA 23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Nektar Therapeutics | 855-482-8676 | StudyInquiry@nektar.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2021 | Mar 28, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D008231 | Lymphopenia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000611752 | bempegaldesleukin |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| OG003 | Placebo | Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration. All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
|
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Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1
All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution.
| OG002 | Bempegaldesleukin 0.003 mg/kg | Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| OG003 | Placebo | Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration. All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
|
|
Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| OG003 | Placebo | Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration. All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
|
|
| OG003 | Placebo | Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration. All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
|
|
| OG001 | Bempegaldesleukin 0.0015 mg/kg | Bempegaldesleukin at dose of 0.0015 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| OG002 | Bempegaldesleukin 0.003 mg/kg | Bempegaldesleukin at dose of 0.003 mg/kg was given by IV infusion as a single dose administered over 15 (± 5) minutes on Day 1 All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
| OG003 | Placebo | Placebo control consisted of sterile normal saline solution administered at the same volume as the active administration. All patients received standard of care (SOC) for COVID-19 determined by the Investigator or institution, which followed the approved prescribing guidelines in their country and institution. |
|
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