NCT04646044

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid-19
• Coronavirus Disease 2019

Interventions

Type	Name	Description
DRUG	Bempegaldesleukin	Administered as an intravenous infusion
DRUG	Standard of Care	Standard of Care Treatment for COVID-19 Infection
OTHER	Placebo	Administered as an intravenous infusion

Timeline

• Start date: 2020-11-13
• Primary completion: 2021-05-11
• Completion: 2021-05-18
• First posted: 2020-11-27
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study