A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Bamlanivimab; Etesevimab; Placebo; VIR-7831; Bebtelovimab
Intervention description: Administered IV.; Administered IV.; Administered IV.; Administered IV.; Administered IV.
Intervention MeSH terms: Bamlanivimab; Sotrovimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Includes open label arms
Enrollment: 1755.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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 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