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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2021-05-18

Brief Summary

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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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Detailed Description

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Conditions

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Covid-19 Coronavirus Disease 2019

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bempegaldesleukin IV + Standard of Care

Group Type EXPERIMENTAL

Bempegaldesleukin

Intervention Type DRUG

Administered as an intravenous infusion

Standard of Care

Intervention Type DRUG

Standard of Care Treatment for COVID-19 Infection

Placebo + Standard of Care

Group Type PLACEBO_COMPARATOR

Standard of Care

Intervention Type DRUG

Standard of Care Treatment for COVID-19 Infection

Placebo

Intervention Type OTHER

Administered as an intravenous infusion

Interventions

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Bempegaldesleukin

Administered as an intravenous infusion

Intervention Type DRUG

Standard of Care

Standard of Care Treatment for COVID-19 Infection

Intervention Type DRUG

Placebo

Administered as an intravenous infusion

Intervention Type OTHER

Other Intervention Names

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NKTR-214 BEMPEG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No