Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
Status unconfirmed · Phase 2
Conditions studied: Covid19
In brief
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.
Key facts
- Study ID
- NCT04840459
- Run by
- Sohail Rao
- People needed
- 1000
- Starts
- 2020-11-20
- Expected to finish
- 2023-01-31
- Last updated by the study team
- 2022-03-29
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Younger than 12 years of age
- Do not meet criteria to be classified as "high risk'
Where it is running
- DHR Health Institute for Research and Development — Edinburg, Texas, United States (enrolling)
- DHR Health — Edinburg, Texas, United States (enrolling)
- Starr County Memorial Hospital — Rio Grande City, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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