Recruiting
Phase 2

Bamlanivimab, Casirivimab, Imdevimab

Sponsor:

Sohail Rao

Code:

NCT04840459

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

BAMLANIVIMAB

CASIRIVIMAB

IMDEVIMAB

Study Details

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.

Conditions

Covid19

Study ID

NCT04840459

Start date

Nov 20, 2020

Status verified date

Mar, 2022

Completion date

Jan 31, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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'

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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

Interventions

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.

Primary outcome 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. [ Time Frame: two weeks ]

Central Contacts and Locations

Central contacts

Sohail Rao, MD

9563622387s.rao@dhr-rgv.com

Monica Betancourt-Garcia, MD

956-3623223m.betancourt@dhr-rgv.com

Locations

DHR Health Institute for Research and Development

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Sohail Rao, MD

956-362-2387s.rao@dhr-rgv.com

Monica Betancourt-Garcia, MD

9563623223m.betancourt@dhr-rgv.com

Principal Investigator:

Sohail Rao, MD

DHR Health

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Sohail Rao, MD

956-362-2387s.rao@dhr-rgv.com

Monica Garcia-Betancourt, MD

9563623223m.betancourt@dhr-rgv.com

Principal Investigator:

Sohail Rao, MD

Starr County Memorial Hospital

Recruiting

Rio Grande City, Texas, United States, 78582

Contacts

Sohail Rao, MD

956-362-2387s.rao@dhr-rgv.com

Monica Garcia-Betancourt, MD

9563623223m.betancourt@dhr-rgv.com

Principal Investigator:

Sohail Rao, MD

More Information

Sponsor

Sohail Rao

Last update posted

Mar 29, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sohail Rao on 2022-03-29.