Coronavirus Disease 2019, Covid-19
Conditions
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
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.
Interventions
Administered as an intravenous infusion
DRUGStandard of Care
Standard of Care Treatment for COVID-19 Infection
OTHERPlacebo
Administered as an intravenous infusion
Sponsors
Nektar Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm. | ALC was evaluated from baseline up to 7 days (Day 8) following the study drug administration. | 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. |
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Safety and tolerability were evaluated from baseline up to approximately 30 days. | 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). |
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | The DLT evaluation period was up to approximately 7 days following the bempegaldesleukin treatment. | 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: * Any Grade ≥ 3 drug-related AE. * Any Grade ≥ 3 drug-related laboratory abnormality that was clinically significant per the Investigator. * Respiratory compromise or other virus-related AE attributed to worsening COVID-19, such as severe hypoxia, cyanosis, or chest pain/pressure. 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. |
| AUC of Bempegaldesleukin [Pharmacokinetic Parameter]. | Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose. | Area under the serum concentration-time curve (AUC) of bempegaldesleukin calculated from time 0 to 168 hours. |
| Cmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose. | Maximum observed serum concentration (Cmax) of bempegaldesleukin. |
| Tmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose. | Time to maximum concentration of bempegaldesleukin. Cmax = maximum concentration. Tmax = time to maximum concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | From baseline up to 7 days (Day 8) following the study drug administration. | 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. |
| Percentage of Patients Who Require Supplemental Oxygen. | From baseline, following the administration of study drug approximately up to 30 days. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 5 |
| 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. | 5 |
| 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. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Bempegaldesleukin 0.00075 mg/kg | Bempegaldesleukin 0.0015 mg/kg | Bempegaldesleukin 0.003 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 32.4 years STANDARD_DEVIATION 5.5 | 31.8 years STANDARD_DEVIATION 7.1 | 40.8 years STANDARD_DEVIATION 12.9 | 35.6 years STANDARD_DEVIATION 11.9 | 35.3 years STANDARD_DEVIATION 10.5 |
| Body Mass Index (BMI) | 28.2 kg/m2 STANDARD_DEVIATION 4.88 | 26.6 kg/m2 STANDARD_DEVIATION 2.03 | 27.5 kg/m2 STANDARD_DEVIATION 5.13 | 27.8 kg/m2 STANDARD_DEVIATION 4.62 | 27.6 kg/m2 STANDARD_DEVIATION 4.24 |
| Diastolic Blood Pressure (BP) | 80.4 mmHg STANDARD_DEVIATION 3.21 | 77.4 mmHg STANDARD_DEVIATION 7.3 | 82.8 mmHg STANDARD_DEVIATION 5.45 | 78.1 mmHg STANDARD_DEVIATION 9.6 | 79.1 mmHg STANDARD_DEVIATION 7.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 4 Participants | 13 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Oxygen Saturation at Room Air | 97.4 % STANDARD_DEVIATION 1.82 | 97.6 % STANDARD_DEVIATION 0.55 | 97.8 % STANDARD_DEVIATION 0.45 | 97.7 % STANDARD_DEVIATION 1.33 | 97.7 % STANDARD_DEVIATION 1.18 |
| Pulse Rate | 72.8 beats/minute STANDARD_DEVIATION 6.98 | 78.0 beats/minute STANDARD_DEVIATION 6.52 | 79.8 beats/minute STANDARD_DEVIATION 3.7 | 73.5 beats/minute STANDARD_DEVIATION 9.3 | 75.2 beats/minute STANDARD_DEVIATION 7.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 4 Participants | 14 Participants | 27 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 5 participants | 15 participants | 30 participants |
| Respiration Rate | 15.8 breaths/minute STANDARD_DEVIATION 1.1 | 16.2 breaths/minute STANDARD_DEVIATION 0.45 | 16.6 breaths/minute STANDARD_DEVIATION 0.89 | 16.1 breaths/minute STANDARD_DEVIATION 0.52 | 16.2 breaths/minute STANDARD_DEVIATION 0.7 |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 1 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 4 Participants | 10 Participants | 22 Participants |
| Systolic Blood Pressure (BP) | 125.4 mmHg STANDARD_DEVIATION 7.44 | 119.2 mmHg STANDARD_DEVIATION 15.35 | 125.0 mmHg STANDARD_DEVIATION 6.28 | 122.3 mmHg STANDARD_DEVIATION 13 | 122.8 mmHg STANDARD_DEVIATION 11.47 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 15 |
| other Total, other adverse events | 3 / 5 | 5 / 5 | 2 / 5 | 4 / 15 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 15 |
Outcome results
Primary
AUC of Bempegaldesleukin [Pharmacokinetic Parameter].
Area under the serum concentration-time curve (AUC) of bempegaldesleukin calculated from time 0 to 168 hours.
Time frame: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
Population: Participants with PK concentration profile to enable AUC calculation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bempegaldesleukin 0.00075 mg/kg | AUC of Bempegaldesleukin [Pharmacokinetic Parameter]. | 153.2 hr*ng/ml | Geometric Coefficient of Variation 62.5 |
| Bempegaldesleukin 0.0015 mg/kg | AUC of Bempegaldesleukin [Pharmacokinetic Parameter]. | 997.4 hr*ng/ml | Geometric Coefficient of Variation 249.6 |
| Bempegaldesleukin 0.003 mg/kg | AUC of Bempegaldesleukin [Pharmacokinetic Parameter]. | 2704.7 hr*ng/ml | Geometric Coefficient of Variation 73.8 |
Primary
Cmax of Bempegaldesleukin [Pharmacokinetic Parameter].
Maximum observed serum concentration (Cmax) of bempegaldesleukin.
Time frame: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
Population: Participants with PK concentration profile to enable Cmax calculation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bempegaldesleukin 0.00075 mg/kg | Cmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | 5.33 ng/ml | Geometric Coefficient of Variation 135.7 |
| Bempegaldesleukin 0.0015 mg/kg | Cmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | 12.67 ng/ml | Geometric Coefficient of Variation 350.8 |
| Bempegaldesleukin 0.003 mg/kg | Cmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | 65.16 ng/ml | Geometric Coefficient of Variation 104.1 |
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: * Any Grade ≥ 3 drug-related AE. * Any Grade ≥ 3 drug-related laboratory abnormality that was clinically significant per the Investigator. * Respiratory compromise or other virus-related AE attributed to worsening COVID-19, such as severe hypoxia, cyanosis, or chest pain/pressure. 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.
Time frame: The DLT evaluation period was up to approximately 7 days following the bempegaldesleukin treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bempegaldesleukin 0.00075 mg/kg | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Bempegaldesleukin 0.003 mg/kg | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Placebo | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 0 Participants |
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).
Time frame: Safety and tolerability were evaluated from baseline up to approximately 30 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bempegaldesleukin 0.00075 mg/kg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Grade 5 | 0 Participants |
| Bempegaldesleukin 0.00075 mg/kg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Grade 3-4 | 0 Participants |
| Bempegaldesleukin 0.00075 mg/kg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Any Grade | 2 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Grade 5 | 0 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Any Grade | 3 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Grade 3-4 | 0 Participants |
| Bempegaldesleukin 0.003 mg/kg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Any Grade | 1 Participants |
| Bempegaldesleukin 0.003 mg/kg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Grade 5 | 0 Participants |
| Bempegaldesleukin 0.003 mg/kg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Grade 3-4 | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Grade 3-4 | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Grade 5 | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants with TEAEs of Any Grade | 4 Participants |
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.
Time frame: ALC was evaluated from baseline up to 7 days (Day 8) following the study drug administration.
Population: Analysis population included patients with both baseline and Day 8 ALC measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bempegaldesleukin 0.00075 mg/kg | Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm. | 5.85 Percent change from baseline | Standard Deviation 21.456 |
| Bempegaldesleukin 0.0015 mg/kg | Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm. | 46 Percent change from baseline | — |
| Bempegaldesleukin 0.003 mg/kg | Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm. | 65.82 Percent change from baseline | Standard Deviation 60.201 |
| Placebo | Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm. | -4.54 Percent change from baseline | Standard Deviation 19.663 |
Primary
Tmax of Bempegaldesleukin [Pharmacokinetic Parameter].
Time to maximum concentration of bempegaldesleukin. Cmax = maximum concentration. Tmax = time to maximum concentration.
Time frame: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
Population: Participants with PK concentration profile to enable Tmax calculation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bempegaldesleukin 0.00075 mg/kg | Tmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | 0.067 hours |
| Bempegaldesleukin 0.0015 mg/kg | Tmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | 0.383 hours |
| Bempegaldesleukin 0.003 mg/kg | Tmax of Bempegaldesleukin [Pharmacokinetic Parameter]. | 0.258 hours |
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.
Time frame: From baseline up to 7 days (Day 8) following the study drug administration.
Population: Analysis population included patients with both baseline and Day 8 scores.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bempegaldesleukin 0.00075 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with more than 2-point worsening | 0 Participants |
| Bempegaldesleukin 0.00075 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 1-point improvement | 0 Participants |
| Bempegaldesleukin 0.00075 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 1-point worsening | 0 Participants |
| Bempegaldesleukin 0.00075 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with no change from baseline | 5 Participants |
| Bempegaldesleukin 0.00075 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 2-point worsening | 0 Participants |
| Bempegaldesleukin 0.00075 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 2-point improvement | 0 Participants |
| Bempegaldesleukin 0.00075 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with more than 2-point improvement | 0 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 2-point improvement | 0 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with more than 2-point improvement | 0 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with more than 2-point worsening | 0 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with no change from baseline | 2 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 1-point improvement | 2 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 1-point worsening | 0 Participants |
| Bempegaldesleukin 0.0015 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 2-point worsening | 0 Participants |
| Bempegaldesleukin 0.003 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with more than 2-point worsening | 0 Participants |
| Bempegaldesleukin 0.003 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with no change from baseline | 0 Participants |
| Bempegaldesleukin 0.003 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 1-point improvement | 3 Participants |
| Bempegaldesleukin 0.003 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 2-point improvement | 1 Participants |
| Bempegaldesleukin 0.003 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with more than 2-point improvement | 0 Participants |
| Bempegaldesleukin 0.003 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 1-point worsening | 1 Participants |
| Bempegaldesleukin 0.003 mg/kg | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 2-point worsening | 0 Participants |
| Placebo | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 1-point worsening | 1 Participants |
| Placebo | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 1-point improvement | 6 Participants |
| Placebo | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 2-point improvement | 1 Participants |
| Placebo | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with 2-point worsening | 0 Participants |
| Placebo | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with no change from baseline | 7 Participants |
| Placebo | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with more than 2-point improvement | 0 Participants |
| Placebo | Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. | Patients with more than 2-point worsening | 0 Participants |
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.
Time frame: From baseline, following the administration of study drug approximately up to 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bempegaldesleukin 0.00075 mg/kg | Percentage of Patients Who Require Supplemental Oxygen. | 0 % of participants |
| Bempegaldesleukin 0.0015 mg/kg | Percentage of Patients Who Require Supplemental Oxygen. | 0 % of participants |
| Bempegaldesleukin 0.003 mg/kg | Percentage of Patients Who Require Supplemental Oxygen. | 0 % of participants |
| Placebo | Percentage of Patients Who Require Supplemental Oxygen. | 0 % of participants |