Covid19
Conditions
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.
Interventions
BIOLOGICALBAMLANIVIMAB
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.
BIOLOGICALCASIRIVIMAB
CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
BIOLOGICALIMDEVIMAB
IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
Sponsors
Sohail Rao
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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'
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determine Rate of Recovery after monoclonal antibody therapy | six weeks from monoclonal administration | Participants will complete a questionnaire that will ask them to answer when symptoms started and how long after monoclonal antibody therapy did participants begin to feel better |
| Determine if if Hospitalization occurred after monoclonal | six weeks from monoclonal administration | Participants will complete a questionnaire that will ask them how they felt after monoclonal antibody therapy and whether or not they required hospitalization. Medical records will be reviewed to confirm. |
Countries
United States
Contacts
Primary ContactSohail Rao, MD
Backup ContactMonica Betancourt-Garcia, MD
Outcome results
None listed