A Study of LY3819253 (LY-CoV555) in Participants With Mild to Moderate COVID-19 Illness

  • STATUS
    Recruiting
  • participants needed
    400
  • sponsor
    Eli Lilly and Company
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Updated on 16 February 2024
See if I qualify
body mass index
fever
renal disease
cardiovascular disease
heart disease
asthma
hypertension
dyspnea
immunosuppressive agents
chronic disease
chronic obstructive pulmonary disease
respiratory disorder
cough
headache
sickle cell disease
intermittent positive pressure ventilation
pharyngitis
covid-19
gastrointestinal symptoms
malaise
myalgia
sickle cell anemia
lung disease
sore throat
chronic respiratory disease
throat

Summary

The purpose of this study is to measure how well LY3819253 works against the virus that causes COVID-19. LY3819253 will be given to participants with early symptoms of COVID-19, via an injection into a vein. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone.

Details
Condition Covid 19
Age 18years - 100years
Treatment Placebo, LY3819253
Clinical Study IdentifierNCT04427501
SponsorEli Lilly and Company
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Are currently not hospitalized
Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion
Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
Are men or non-pregnant women who agree to contraceptive requirements
Understand and agree to comply with planned study procedures
Agree to the collection of nasopharyngeal swabs and venous blood
The participant or legally authorized representative give signed informed consent

Exclusion Criteria

Have oxygen saturation (SpO2) less than or equal to ()93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate greater than or equal to ()30 per minute, heart rate 125 per minute
Require mechanical ventilation or anticipated impending need for mechanical ventilation
Have known allergies to any of the components used in the formulation of the interventions
Have hemodynamic instability requiring use of pressors within 24 hours of randomization
Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days
Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study
Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
Have received treatment with a SARS-CoV-2 specific monoclonal antibody
Have a history of convalescent COVID-19 plasma treatment
Have participated in a previous SARS-CoV-2 vaccine study
Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Are pregnant or breast feeding
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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body mass index
fever
renal disease
cardiovascular disease
heart disease
asthma
hypertension
dyspnea
immunosuppressive agents
chronic disease
chronic obstructive pulmonary disease
respiratory disorder
cough
headache
sickle cell disease
intermittent positive pressure ventilation
pharyngitis
covid-19
gastrointestinal symptoms
malaise
myalgia
sickle cell anemia
lung disease
sore throat
chronic respiratory disease
throat

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