Status:
UNKNOWN
Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
Lead Sponsor:
Sohail Rao
Conditions:
Covid19
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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'
Exclusion
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04840459
Start Date
November 20 2020
End Date
January 31 2023
Last Update
March 29 2022
Active Locations (3)
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1
DHR Health Institute for Research and Development
Edinburg, Texas, United States, 78539
2
DHR Health
Edinburg, Texas, United States, 78539
3
Starr County Memorial Hospital
Rio Grande City, Texas, United States, 78582