COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04646044

Nektar Therapeutics

studyinquiry@nektar.com

2020-11-27

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

- 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.

2

Nektar Therapeutics

18

100

United States

Mild disease at enrollment

1: Mild disease at enrollment

30

AUC of Bempegaldesleukin [Pharmacokinetic Parameter].;Cmax of Bempegaldesleukin [Pharmacokinetic Parameter].;Number of Participants Experiencing Dose-Limiting Toxicities (DLTs);Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability];Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm.;Tmax of Bempegaldesleukin [Pharmacokinetic Parameter].

None

Phase 1

[{"arm_notes": "", "treatment_id": 676, "treatment_name": "Interleukin-2", "treatment_type": "Interleukins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]