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

Sponsor

Nektar Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT04646044

Collaborator

(none)

Enrollment

Locations

Arms

6.1

Actual Duration (Months)

7.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid-19 Coronavirus Disease 2019	Drug: Bempegaldesleukin Drug: Standard of Care Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 13, 2020

Actual Primary Completion Date :

May 11, 2021

Actual Study Completion Date :

May 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

AUC of BEMPEG/standard of care (SOC) (PK). [Approximately 30 days]
Area under the serum concentration-time curve (AUC) of BEMPEG /SOC.
Cmax of BEMPEG /SOC (PK). [Approximately 30 days]
Maximum observed serum concentration (Cmax) of BEMPEG /SOC.
Tmax of BEMPEG /SOC (PK). [Approximately 30 days]
Time to Cmax (Tmax) of BEMPEG /SOC.
Incidence of adverse events. [Approximately 30 days]
Incidence of treatment emergent adverse events (TEAEs). [Approximately 30 days]
Incidence of serious adverse events (SAEs). [Approximately 30 days]
Incidence of dose limiting toxicities (DLT) for BEMPEG. [Approximately 30 days]
Presence and levels of anti-drug antibodies directed to BEMPEG. [Approximately 30 days]
Fold change from baseline in absolute lymphocyte count by Central Laboratory. [Approximately 30 days]

Secondary Outcome Measures

Percentage of patients who require supplemental oxygen. [Approximately 30 days]
Change from baseline on the daily collection World Health Organization (WHO) Clinical Progression Scale, an 11-point clinical status ordinal scale. [Approximately 30 days]
The WHO Clinical Progression Scale scores and descriptors are as follows: 0- Uninfected; no viral RNA detected; 1- Asymptomatic; viral RNA detected; 2- Symptomatic; independent; 3- Symptomatic; assistance needed; 4- Hospitalized, no oxygen therapy; 5- Hospitalized; oxygen by mask or nasal prongs ; 6- Hospitalized; oxygen by non-invasive ventilation or high-flow; 7- Intubation and mechanical ventilation, PaO2/FiO2 ≥ 150 or SpO2/FiO2 ≥ 200; 8- Mechanical ventilation, PaO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors; 9- Mechanical ventilation, PaO2/FiO2 < 150 and vasopressors, dialysis, or ECMO; 10- Death Abbreviations: ECMO = extracorporeal membrane oxygenation; FiO2 = fraction of inspired oxygen; PaO2 = partial pressure of arterial oxygen; SpO2 = oxygen saturation If hospitalized for isolation only, record status as for ambulatory patient. Source: WHO 2020.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	A G A Clinical Trials - HyperCore - PPDS	Hialeah	Florida	United States	33012
2	New Generation Medical Research	Hialeah	Florida	United States	33016
3	Clinical Site Partners - Winter Park - HyperCore -PPDS	Winter Park	Florida	United States	32789
4	SMS Clinical Research, LLC	Mesquite	Texas	United States	75149