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

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04634409

Run by

Eli Lilly and Company

People needed

1755

Starts

2020-10-29

Expected to finish

2021-10-18

Last updated by the study team

2022-07-01

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 severe acute respiratory syndrome coronavirus 2 (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

Where it is running

• The Institute for Liver Health — Mesa, Arizona, United States
• Perseverance Research Center — Scottsdale, Arizona, United States
• CRI of Arizona, LLC — Sun City West, Arizona, United States
• Fiel Family and Sports Medicine PC — Tempe, Arizona, United States
• The Institute for Liver Health — Tucson, Arizona, United States
• KLR Business Group, Inc. dba Arkansas Clinical Research — Little Rock, Arkansas, United States
• Applied Rsch Ctr - Arkansas Inc. — Little Rock, Arkansas, United States
• Smart Cures Clin Research — Anaheim, California, United States
• Hope Clinical Research — Canoga Park, California, United States
• VCT-Covina — Covina, California, United States
• Neighborhood Healthcare — Escondido, California, United States
• Chemidox Clinical Trials — Lancaster, California, United States
• Ark Clinical Research — Long Beach, California, United States
• Long Beach Clinical Trials LLC — Long Beach, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Central Valley Research, LLC — Modesto, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• Sutter Institute For Medical Research — Sacramento, California, United States
• Wolverine Clinical Trials, LLC — Santa Ana, California, United States
• St. Joe Heritage HC-Santa Rosa — Santa Rosa, California, United States
• Stanford University Hospital — Stanford, California, United States
• Mazur, Statner, Dutta, Nathan — Thousand Oaks, California, United States
• South Bay Clinical Research Institute — Torrance, California, United States
• Infect Disease Doctors Med Grp — Walnut Creek, California, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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