Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting

Study Overview
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Brief Summary
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No therapeutic agent is currently approved for the treatment of SARSCoV-2 infection. More importantly, no intervention is currently available to mitigate the progression of disease from mid/moderate to serve particularly in high risk patients. Recognizing this limitation and urgency of finding a treatment for COVID-19, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergencyuse of the unapproved product bamlanivimab or casirivimab + imdevimab for the treatment of mild to moderate coronavirus disease 2019 (COVID19) in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Official Title
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Use of Monoclonal Antibodies (Bamlanivimab and Casirivimab + Imdevimab) for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting

Conditions
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Covid19

Intervention / Treatment
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* Biological: BAMLANIVIMAB
* Biological: CASIRIVIMAB
* Biological: IMDEVIMAB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing 12 years of age and older weighing at least 40 kg are at :high risk for progressing to severe COVID-19 and/or hospitalization High risk is defined as patients who meet at least one of the following criteria: Have a body mass index (BMI) >35 Have chronic kidney disease Have diabetes Have immunosuppressive disease Are currently receiving immunosuppressive treatment Are over 65 years of age Are over 55 years of age AND have: cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease Are 12 - 17 years of age AND have BMI >85th percentile for their age and gender based on CDC o growth charts, ii. sickle cell disease OR iii. congenital or acquired heart disease OR iv. neurodevelopmental disorders, for example, cerebral palsy, OR a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR v. asthma, reactive airway or other chronic respiratory disease o that requires daily medication for control. Exclusion Criteria Younger than 12 years of age Do not meet criteria to be classified as high risk'

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAMLANIVIMAB<br>The dosage of bamlanivimab in adults and pediatric patients 12 years of age and older weighing at least 40 kg is a single IV infusion of 700 mg bamlanivimab administered over at least 60 minutes | Biological: BAMLANIVIMAB<br>* n. Bamlanivimab is a recombinant neutralizing human mIgG1? monoclonal antibody (mAb) to the spike protein of SARS-CoV-2, and is unmodified in the Fc region.<br>|
| Experimental: CASIRIVIMAB + IMDEVIMAB<br>10 mL of casirivimab and 10 mL of imdevimab from each respective vial using two separate syringes and dilute together in the infusion bag containing 0.9% Sodium Chloride Injection | Biological: CASIRIVIMAB<br>* CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.<br>Biological: IMDEVIMAB<br>* IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimize and/or eliminate the number of patients with mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 and/or hospitalization. | Will record the number of participants who are prevented from progressing to sever infection. | two weeks |