Phase 1
Completed N=30
A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19
Source: ClinicalTrials.gov NCT04646044 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: AUC of Bempegaldesleukin [Pharmacokinetic Parameter]. — 153.2; 997.4; 2704.7 hr*ng/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC of Bempegaldesleukin [Pharmacokinetic Parameter]. |
153.2; 997.4; 2704.7 | — |
| PRIMARY Cmax of Bempegaldesleukin [Pharmacokinetic Parameter]. |
5.33; 12.67; 65.16 | — |
| PRIMARY Tmax of Bempegaldesleukin [Pharmacokinetic Parameter]. |
0.067; 0.383; 0.258 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] |
2; 3; 1; 4; 0; 0 | — |
| PRIMARY Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) |
0; 0; 0; 0 | — |
| PRIMARY Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm. |
5.85; 46; 65.82; -4.54 | — |
| SECONDARY Percentage of Patients Who Require Supplemental Oxygen. |
0; 0; 0; 0 | — |
| SECONDARY Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale. |
5; 2; 0; 7; 0; 2 | — |
Eligibility Criteria
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 93% on room air.
- Body mass index 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 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.
Data sourced from ClinicalTrials.gov (NCT04646044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.