A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19

Nektar Therapeutics

Status and phase: Completed; Phase 1

Conditions: Coronavirus Disease 2019; Covid-19

Treatments: Other: Placebo; Drug: Bempegaldesleukin; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04646044

20-214-34

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Bempegaldesleukin IV + Standard of Care

Experimental group

Treatment:

Drug: Standard of Care

Drug: Bempegaldesleukin

Placebo + Standard of Care

Placebo Comparator group

Treatment:

Other: Placebo

Drug: Standard of Care