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

COMPLETEDPHASE1

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

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

NCT04646044•Nektar Therapeutics

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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.
+3 more criteria

Locations (4)

A G A Clinical Trials - HyperCore - PPDS

Hialeah, Florida, United States

New Generation Medical Research

Hialeah, Florida, United States

Clinical Site Partners - Winter Park - HyperCore -PPDS

Winter Park, Florida, United States

SMS Clinical Research, LLC

Mesquite, Texas, United States

Key Dates

Start Date

November 13, 2020

Primary Completion Date

May 11, 2021

Completion Date

May 18, 2021

Last Updated

March 12, 2024

Enrollment

ACTUAL participants

Conditions

Covid-19Coronavirus Disease 2019

Interventions

Bempegaldesleukin

DRUG

Standard of Care

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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