A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 in Adults Hospitalized with COVID-19 - M20-404

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年4月9日

试验速览

Trial never started

•1. Adult, at least 18 years old, weighing at least 45 kg
•2. Confirmed SARS-CoV-2 infection based on initial nucleic acid or antigen
•testing from respiratory swab, saliva, or other bodily fluid within 7 days
•prior to randomization (note: timing based on date of test result)
•3. Must have >= 1 symptom associated with COVID-19 (e.g., fever, chills/sweats,
•cough, shortness of breath/dyspnea, sore throat, fatigue, dyspnea, myalgia,
•headache, congestion, gastrointestinal symptoms [nausea, vomiting, diarrhea],
•new loss of taste or smell) with an onset of <= 8 days prior to randomization
•AND evidence of lower respiratory tract infection by clinical assessment or
•4. Hospitalized or plans for hospital admission due to COVID-19 at the time of
•randomization

•1. Must not have an oxygen saturation (SpO2) < 88% on room air at rest for 5
•minutes OR ratio of arterial partial pressure of oxygen to fraction of inspired
•oxygen (PaO2/FiO2) <= 200 mmHg at randomization
•2. Not requiring high-flow oxygen therapy/non-invasive or invasive mechanical
•ventilation/ECMO or anticipated impending need for high-flow oxygen
•therapy/non-invasive or invasive mechanical ventilation/ECMO

发起方