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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
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.
CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
DHR Health Institute for Research and Development
Edinburg, Texas, United States
RECRUITINGDHR Health
Edinburg, Texas, United States
RECRUITINGStarr County Memorial Hospital
Rio Grande City, Texas, United States
RECRUITINGMinimize 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.
Time frame: two weeks
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