Trial Search Results

A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness

The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early symptoms of COVID-19. 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eli Lilly and Company

Collaborator: AbCellera Biologics Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: LY3819253
  • Drug: LY3832479
  • Drug: Placebo

Phase:

Phase 2/Phase 3

Eligibility


Inclusion Criteria:

   - Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)

   - 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. (Not applicable to participants in treatment arm 22.)

   - Must have sample taken for test confirming viral infection no more than 3 days prior
   to starting the drug infusion

   - Are males or females, including pregnant females who agree to contraceptive
   requirements

   - Understand and agree to comply with planned study procedures

   - Agree to the collection of nasopharyngeal swabs and venous blood. (Not applicable to
   participants in treatment arms 20-21.)

   - The participant or legally authorized representative give signed informed consent
   and/or assent

Participants in treatment arms 7-9, 13-14, and 18-21 ONLY

   - Are greater than or equal to (≥)18 years of age and must satisfy at least one of the
   following at the time of screening

      - Are pregnant

      - Are ≥65 years of age

      - Have a body mass index (BMI) ≥35

      - Have chronic kidney disease (CKD)

      - Have type 1 or type 2 diabetes

      - Have immunosuppressive disease

      - Are currently receiving immunosuppressive treatment or

      - Are ≥55 years of age AND have:

         - cardiovascular disease (CVD), OR

         - hypertension, OR

         - chronic obstructive pulmonary disease (COPD) or other chronic respiratory
         disease

   - Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the
   time of screening

      - Are pregnant

      - Have a body mass index (BMI) ≥85th percentile for their age and gender based on
      CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm

      - Have sickle cell disease

      - Have congenital or acquired heart disease

      - Have neurodevelopmental disorders, for example, cerebral palsy

      - Have a medical-related technological dependence, for example, tracheostomy,
      gastrostomy, or positive pressure ventilation (not related to COVID-19)

      - Have asthma or reactive airway or other chronic respiratory disease that requires
      daily medication for control

      - Have type 1 or type 2 diabetes

      - Have chronic kidney disease

      - Have immunosuppressive disease, or

      - Are currently receiving immunosuppressive treatment

Participants in treatment arm 22 ONLY

- Are 0 (≥ 32 weeks gestational age AND ≥ 1.5 kilograms [kg]) to 17 years of age
(inclusive) AND satisfy at least one of the following risk factors at the time of screening

   - Are pregnant

   - Have a BMI ≥85th percentile for their age and gender based on CDC growth charts,
   https://www.cdc.gov/growthcharts/clinical_charts.htm

   - Have sickle cell disease

   - Have congenital or acquired heart disease

   - Have neurodevelopmental disorders, for example, cerebral palsy, autism, or Down
   syndrome (FAIR Health 2020; Spreat et al. 2020)

   - Have a medical-related technological dependence, for example, tracheostomy,
   gastrostomy, or positive pressure ventilation (not related to COVID-19)

   - Have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory
   disease that requires daily medication for control

   - Have type 1 or type 2 diabetes

   - Have chronic kidney disease

   - Have immunosuppressive disease, or

   - Are currently receiving immunosuppressive treatment, or

   - Are less than (<) one year of age.

   - Have one or more COVID-19 symptoms

      - Shortness of breath/difficulty breathing

      - Fever

      - Sore throat

      - Nausea

      - Diarrhea

      - Tiredness

      - Headache

      - New loss of taste

      - Nasal congestion/runny nose

      - Chills

      - Stomachache

      - Vomiting

      - Cough

      - Muscle/body aches and pain

      - New loss of smell

      - Poor appetite or poor feeding (in babies)

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 due to COVID-19

   - Require mechanical ventilation or anticipated impending need for mechanical
   ventilation due to COVID-19

   - 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 received convalescent COVID-19 plasma treatment

   - Have participated in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2
   vaccine

   - 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

   - Mothers who are breast feeding

Participants in Treatment Arm 22 ONLY

   - Have a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) in the
   opinion of the investigator

   - Are currently hospitalized for treatment of COVID-19. Other reasons for
   hospitalization are acceptable.

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
833-277-0197
Not Recruiting