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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAMLANIVIMAB | Experimental | The dosage of bamlanivimab in adults and pediatric patients 12 years of age and older weighing at least 40 kg is a single IV infusion of 700 mg bamlanivimab administered over at least 60 minutes |
|
| CASIRIVIMAB + IMDEVIMAB | Experimental | 10 mL of casirivimab and 10 mL of imdevimab from each respective vial using two separate syringes and dilute together in the infusion bag containing 0.9% Sodium Chloride Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAMLANIVIMAB | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Will record the number of participants who are prevented from progressing to sever infection. | two weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine Rate of Recovery after monoclonal antibody therapy | 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 | six weeks from monoclonal administration |
| Determine if if Hospitalization occurred after monoclonal |
Inclusion Criteria:
High risk is defined as patients who meet at least one of the following criteria:
v. asthma, reactive airway or other chronic respiratory disease o that requires daily medication for control.
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sohail Rao, MD | Contact | 9563622387 | s.rao@dhr-rgv.com | |
| Monica Betancourt-Garcia, MD | Contact | 956-3623223 | m.betancourt@dhr-rgv.com |
| Name | Affiliation | Role |
|---|---|---|
| Sohail Rao, MD | DHR Heath Institute for Research and Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DHR Health Institute for Research and Development | Recruiting | Edinburg | Texas | 78539 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711749 | bamlanivimab |
| C000711487 | casirivimab |
| C000711488 | imdevimab |
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| CASIRIVIMAB | Biological | CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions. |
|
| IMDEVIMAB | Biological | IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions. |
|
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. |
| six weeks from monoclonal administration |
| DHR Health | Recruiting | Edinburg | Texas | 78539 | United States |
|
| Starr County Memorial Hospital | Recruiting | Rio Grande City | Texas | 78582 | United States |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |