Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
- Conditions
- Covid19
- Interventions
- Biological: BAMLANIVIMABBiological: CASIRIVIMABBiological: IMDEVIMAB
- Registration Number
- NCT04840459
- Lead Sponsor
- Sohail Rao
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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'
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BAMLANIVIMAB BAMLANIVIMAB 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 CASIRIVIMAB + IMDEVIMAB IMDEVIMAB 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 CASIRIVIMAB + IMDEVIMAB CASIRIVIMAB 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
- Primary Outcome Measures
Name Time Method 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. two weeks Will record the number of participants who are prevented from progressing to sever infection.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
DHR Health Institute for Research and Development
🇺🇸Edinburg, Texas, United States
DHR Health
🇺🇸Edinburg, Texas, United States
Starr County Memorial Hospital
🇺🇸Rio Grande City, Texas, United States