A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)
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.
• 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