Clinical trial NCT04840459: Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
Official title: Use of Monoclonal Antibodies (Bamlanivimab and Casirivimab + Imdevimab) for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
Lead sponsor: DHR Health Institute for Research and Development
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing
2. 12 years of age and older weighing at least 40 kg
3. 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:

1. Have a body mass index (BMI) \>35
2. Have chronic kidney disease
3. Have diabetes
4. Have immunosuppressive disease
5. Are currently receiving immunosuppressive treatment
6. Are over 65 years of age
7. Are over 55 years of age AND have: cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease
8. Are 12 - 17 years of age AND have
9. 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

1. Younger than 12 years of age
2. Do not meet criteria to be classified as "high risk'

Primary outcomes:
measure: 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.
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
measure: Determine Rate of Recovery after monoclonal antibody therapy
timeFrame: six weeks from monoclonal administration
measure: Determine if if Hospitalization occurred after monoclonal
timeFrame: six weeks from monoclonal administration
Locations:
city: Edinburg
country: United States
facility: DHR Health Institute for Research and Development
state: Texas
city: Edinburg
country: United States
facility: DHR Health
state: Texas
city: Rio Grande City
country: United States
facility: Starr County Memorial Hospital
state: Texas
Study officials:
affiliation: DHR Heath Institute for Research and Development
name: Sohail Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: