Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
NCT ID: NCT04840459
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
1000 participants
INTERVENTIONAL
2020-11-20
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BAMLANIVIMAB
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
BAMLANIVIMAB
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.
CASIRIVIMAB + IMDEVIMAB
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
CASIRIVIMAB
CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
IMDEVIMAB
IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
Interventions
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BAMLANIVIMAB
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.
CASIRIVIMAB
CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
IMDEVIMAB
IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
Eligibility Criteria
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Inclusion Criteria
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
2. Do not meet criteria to be classified as "high risk'
12 Years
ALL
No
Sponsors
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Sohail Rao
OTHER
Responsible Party
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Sohail Rao
President and CEO
Principal Investigators
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Sohail Rao, MD
Role: PRINCIPAL_INVESTIGATOR
DHR Heath Institute for Research and Development
Locations
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DHR Health Institute for Research and Development
Edinburg, Texas, United States
DHR Health
Edinburg, Texas, United States
Starr County Memorial Hospital
Rio Grande City, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1686206
Identifier Type: -
Identifier Source: org_study_id
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