Trial Search Results

A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness

The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) 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 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.

Stanford is currently 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
  • Drug: VIR-7831
  • Drug: LY3853113

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - For low-risk participant arms 9-11 only: Are greater than or equal to (≥)18 and less
   than (<)65 years of age at the time of randomization and do not have the risk factors
   defined in the bullet point directly below

   - For high-risk participant arms 12 and 13 only:

   -- Are ≥18 years of age and satisfy at least one of the following risk factors at the
   time of screening

      - Are ≥65 years of age

      - Have a body mass index (BMI) ≥ 35

      - Have chronic kidney disease

      - 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, OR

         - hypertension, OR

         - chronic obstructive pulmonary disease or other chronic respiratory disease

   - For high-risk participant arms 12 and 13 only:

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

         - 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

         - 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.

For high-risk participants arm 14 only:

   - Are ≥12 years of age and satisfy at least one of the following risk factors at the
   time of screening Are ≥65 years of age

   - Are adults (≥18 years of age) with BMI >25 kg/m2 , or if age 12-17, have BMI ≥85th
   percentile for their age and gender based on CDC growth charts

   - Have chronic kidney disease

   - Have type 1 or type 2 diabetes

   - Have immunosuppressive disease

   - Are currently receiving immunosuppressive treatment

   - Have cardiovascular disease (including congenital heart disease) or hypertension

   - Have chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma
   [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary
   hypertension)

   - Have sickle cell disease

   - Have neurodevelopmental disorder (for example, cerebral palsy) or other conditions
   that confer medical complexity (for example, genetic or metabolic syndromes and severe
   congenital anomalies)

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

   - 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, nasal congestion or runny nose, new loss of smell, chills

   - 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
   and/or assent

Exclusion Criteria:

   - For low-risk participants only: BMI ≥35

   - 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) <300, respiratory rate ≥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

   - For low-risk arms only: have received a SARS-CoV-2 vaccine or have participated in a
   previous SARS-CoV-2 vaccine study and are currently blinded to treatment allotment

   - 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

   - Are investigator site personnel directly affiliated with this study

   - Have body weight <40 kilograms

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
650-723-9656
Recruiting