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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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/Exclusion criteria may apply.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bempegaldesleukin IV + Standard of Care
  • Drug: Bempegaldesleukin
    Administered as an intravenous infusion
    Other names:
    • NKTR-214
    • BEMPEG
  • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection
Placebo Comparator
Placebo + Standard of Care
  • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection
  • Other: Placebo
    Administered as an intravenous infusion

Recruiting Locations

More Details

NCT ID
NCT04646044
Status
Completed
Sponsor
Nektar Therapeutics

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.