Clinical trial NCT04646044: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: AUC of Bempegaldesleukin [Pharmacokinetic Parameter].
timeFrame: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
measure: Cmax of Bempegaldesleukin [Pharmacokinetic Parameter].
timeFrame: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
measure: Tmax of Bempegaldesleukin [Pharmacokinetic Parameter].
timeFrame: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
measure: Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Safety and tolerability were evaluated from baseline up to approximately 30 days.
measure: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
timeFrame: The DLT evaluation period was up to approximately 7 days following the bempegaldesleukin treatment.
measure: Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm.
timeFrame: ALC was evaluated from baseline up to 7 days (Day 8) following the study drug administration.
Secondary outcomes:
measure: Percentage of Patients Who Require Supplemental Oxygen.
timeFrame: From baseline, following the administration of study drug approximately up to 30 days.
measure: Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale.
timeFrame: From baseline up to 7 days (Day 8) following the study drug administration.
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: A G A Clinical Trials - HyperCore - PPDS
state: Florida
city: Hialeah
country: United States
facility: New Generation Medical Research
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners - Winter Park - HyperCore -PPDS
state: Florida
city: Mesquite
country: United States
facility: SMS Clinical Research, LLC
state: Texas
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: