Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
Use of Monoclonal Antibodies (Bamlanivimab and Casirivimab + Imdevimab) for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
1 other identifier
interventional
1,000
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Nov 2020
Longer than P75 for phase_2 covid19
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 20, 2020
CompletedFirst Submitted
Initial submission to the registry
April 5, 2021
CompletedFirst Posted
Study publicly available on registry
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedMarch 29, 2022
March 1, 2022
2.1 years
April 5, 2021
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (2)
Determine Rate of Recovery after monoclonal antibody therapy
six weeks from monoclonal administration
Determine if if Hospitalization occurred after monoclonal
six weeks from monoclonal administration
Study Arms (2)
BAMLANIVIMAB
EXPERIMENTALThe 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
EXPERIMENTAL10 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
Interventions
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 is a recombinant human mAbs which are unmodified in the Fc regions.
IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
Eligibility Criteria
You may qualify if:
- adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing
- 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.
You may not qualify if:
- Younger than 12 years of age
- Do not meet criteria to be classified as "high risk'
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohail Raolead
Study Sites (3)
DHR Health Institute for Research and Development
Edinburg, Texas, 78539, United States
DHR Health
Edinburg, Texas, 78539, United States
Starr County Memorial Hospital
Rio Grande City, Texas, 78582, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sohail Rao, MD
DHR Heath Institute for Research and Development
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- President and CEO
Study Record Dates
First Submitted
April 5, 2021
First Posted
April 12, 2021
Study Start
November 20, 2020
Primary Completion
December 31, 2022
Study Completion
January 31, 2023
Last Updated
March 29, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share